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Exploring Clinical Trials In Myositis (Webinar) #myositis #autoimmunedisease #health #webinar — Transcript

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0:03Greetings to everyone present here
0:05today. I am Mario Patel. I'm part of the
0:07senior management team at Myioitis India
0:09and I'm delighted to welcome you to
0:11today's webinar on clinical trial in
0:13myioitis.
0:14So myioitis India a unit of Malasa
0:16Foundation is a nonprofit dedicated to
0:18supporting people living with myioitis
0:20through patient services, education,
0:22research, collaboration and access to
0:24expert care. We work closely with
0:27patients, caregivers, physicians, and
0:29researchers to ensure that no one with
0:30myitis is left without reliable
0:32information or support. Today's webinar
0:35is designed especially for patients,
0:37caregivers, and anyone who has questions
0:39about clinical trials. Many people hear
0:42the term clinical trial and feel
0:43uncertain, anxious, or confused. Through
0:45this session, we aim to clearly explain
0:48what clinical trials actually are, why
0:50patients are invited to participate, and
0:52what participation truly looks like in
0:54real life. Next slide please. So we
0:56thank Brendon Pharmaceuticals and
0:58Astroenica for the support to the
1:00organization and the webinar and we
1:01would also thank all our patients and
1:03volunteers and supporters. Next slide
1:05please.
1:07So here's how you can become a
1:09volunteer. You can email us and you can
1:12also sign up on our website at
1:13myitisindia.org.
1:15You can donate and you can also help us
1:17with spreading a awareness. Next slide.
1:22These are all our socials including our
1:24website, our Instagram page
1:26myioitis_india,
1:28our Facebook page, our Twitter, our
1:29YouTube and our WhatsApp queries number
1:31will be shared later. Next slide.
1:36So the agenda for today's webinar is we
1:38have three speakers Dr. Rohit Garval,
1:41Dr. Fani Kumar and Dr. Anushkar Raarwal.
1:43Dr. Rohital will take us through bioitis
1:45clinical trials. He will explain what
1:48they are, why they matter and what
1:50patients should know. Dr. Dr. Fani Kumar
1:52will take you through a patient
1:53step-by-step journey of a clinical trial
1:54and Dr. Anushka Agarwal will explain
1:57accessing clinical trials in myitis and
1:59how my India supports patients and
2:01physicians.
2:04So it is now my pleasure to introduce
2:06our first speaker Dr. Rohit Agraal. Dr.
2:08Agraal is a professor of medicine in the
2:10division of rheumatology and clinical
2:11immunology at the University of
2:13Pittsburgh in United States and is a
2:15globally recognized expert in myioitis
2:16and inflammatory muscle diseases. He's a
2:18senior physician and researcher at UPMC
2:21myioitis center and has been closely
2:23involved in several international
2:24clinical trials and research
2:25collaborations in myioitis. Beyond his
2:28academic work, Dr. Agarval has been
2:29working tirelessly to support myitis
2:31patients in India through the Myioitis
2:33India organization, helping improve
2:35awareness, access to expert care and
2:37participation in research. Today, he
2:39will help us understand what clinical
2:41trials really are, why patient
2:43participation matters, and how concerns
2:45about safety and uncertainty their
2:46interest. We are honored to have him
2:48today with us.
2:50>> Thank you. Um can I share my uh slides?
2:55My slides are being shared. Can you
2:58check?
3:00>> Uh and you can see them very well.
3:03>> Yes sir.
3:04>> Okay. Well, first of all, um thank you
3:07to my India um for allowing me to give
3:11this quick talk. Um so what I'm going to
3:14be talking about is what are my what are
3:16clinical trials specifically related to
3:18myioitis and why patients should
3:22participate in clinical trial um um and
3:26what are the benefits what are the risk
3:28of participating in clinical trial.
3:31So first I want to talk about what is
3:33clinical trial because I think there is
3:35there are many misconceptions
3:38uh specifically in India. in India uh
3:40many times people say okay I don't want
3:43to be part of clinical trial because I
3:45don't want to be a guinea pig on whom
3:47you're going to try a drug um so let me
3:50explain um to our viewers what what it
3:52really uh means because what happens is
3:56any drug that you currently get any
3:58doctor that prescribes you any drug
4:01before that drug is approved or even
4:03known that is be used in that treatment
4:06it has gone through extensive clinical
4:08trial
4:09So that means the benefit of any
4:12treatment that you're currently on or
4:15may be getting in future someone else
4:18before you have actually participated in
4:21clinical trial and proved that that drug
4:25works and then that drug is now
4:27available for you. So keep in mind when
4:30you get a treatment someone else
4:34is behind the treatment typically not a
4:36doctor typically a patient who
4:38participated in clinical trial. So when
4:41you say this is um I don't want to be a
4:43guinea pig is kind of think about it
4:45again any treatment you're getting
4:47someone else was your guinea pig. So
4:50keep you know you have to think about
4:52that. The second point I wanted to
4:54explain you is that clinical trial is a
4:56very very safe place. In past people
5:00used to think that oh they will put me
5:02in a trial now I'm stuck. I will get
5:04experimental drug or I will not get a
5:06drug and I don't know what's going to
5:08happen to me. That's not how current
5:11clinical trials operate. Current
5:13clinical trials are highly regulated.
5:15That means there are there are rules and
5:18regulations in place at every level that
5:21that all the way from local to national
5:24to international level that how a
5:26clinical trial is done. So what is a
5:29clinical trial? So typically what would
5:31happen in a clinical trial is there is a
5:33drug that is to be tested for a
5:36particular disease. Before a drug comes
5:39to the clinical trial, there's a lot of
5:42research that already has happened in
5:44that drug in that area. Not just take um
5:48a drug and start experimenting in a
5:50disease. Doctors don't do that before
5:53even get to the clinical trial. We
5:54actually have a very good idea
5:57or almost a preliminary proof that this
6:01drug does work in this disease. So
6:04there's typically about about five years
6:06of research that has done in that dis uh
6:09in that drug in that disease before it
6:12even guts gets to clinical trial. So
6:14actually most clinical trials we
6:16actually know that that the drug will
6:18work otherwise we would not let that
6:19drug come to the clinical trial. So
6:23before that clinical trial we may have
6:24given it to a couple of few patients. We
6:27may have experimented on the lab. We may
6:29have experimented on the rats. So we
6:32actually know that this drug works in
6:33that disease. When you get a clinical
6:36tri when you get to a clinical trial,
6:38what typically happens and this is a
6:40meio myioitis clinical trial. You get a
6:43drug or a placebo. So you get randomized
6:45which means you don't know what will
6:47what whether you will get a drug or a
6:49placebo for about 6 to 12 months. So
6:53then once you finish that period then
6:57typically you will get the real
6:58treatment or drug for next 6 to 12
7:00months. That's how most clinical trials
7:03are planned. So the patients who got the
7:06drug will get the benefit of the drug
7:08for longer period of time and the
7:10patient who got the placebo would also
7:12get the benefit of the drug in the
7:14subsequent period of time after the
7:16first initial phase one period is
7:19complete then the next phase they will
7:21get the drug. And also very importantly
7:24when you get into the clinical trial it
7:27does not mean that you your current
7:30treatment will be stopped. So actually
7:32in most clinical trials your current
7:34treatment is maintained as it is. That
7:37means the doctors that have put you on
7:38any treatment one drug two drug or three
7:40drug that typically is maintained
7:43throughout the clinical trial as
7:45standard of care. So that means when
7:48you're getting a new drug or placebo,
7:50you're getting on the top of your
7:52current treatment. That means if you
7:55join a clinical trial, you may benefit,
7:57but if you get or you get a new drug,
8:00you may benefit, but if you get a
8:02placebo, you're still on your current
8:04treatment. And that is a common
8:06misconception people have that I may
8:08have to stop my current treatment and
8:10what if I get worse? That typically
8:12doesn't happen. We're trying to see if
8:14we can get you even better than what you
8:17currently are. And the last is what if I
8:20worsen and if you worsen there are many
8:23pathways in which the doctor can easily
8:26doctor and patient can easily safeguard
8:28the patient. One, there are additional
8:30treatment allowed as per the trial rules
8:32in many cases where the doctor can give
8:34you additional treatment in case things
8:37are getting worse and the second is if
8:40there is any further problem you can
8:42always have an option to exit the trial
8:44or your doctors can talk to you and see
8:47what best can be done. Um, more
8:50importantly when you join a clinical
8:51trial you're joining as a volunteer. You
8:53do not have to join a clinical trial but
8:56in most cases you benefit from join
8:59clinical trial and I previously
9:01explained there are strict rules by
9:02doctors institution country that that is
9:05that clinical trial done is in a proper
9:07way also I will tell you from my
9:10experience I have at least had
9:12experience of admitting um you know 20
9:1530 40 patients in clinical trial over
9:18the last 10 years. Every time a patient
9:21has joined a clinical trial, they have
9:23thanked me that they are better because
9:26they joined the clinical trial and
9:28they're so happy that they were the
9:30reason that that the drug got approved.
9:33I um there's a drug called approved
9:36called IVIG intermaromyioitis
9:39and I uh enrolled three patients in that
9:41clinical trial. Till date that those
9:44three patient thanked me because of them
9:46a drug is now approved or known to be uh
9:50effective and safe in patients with
9:53dermatomyioitis for example.
9:58So next what I'm going to cover is why
10:01join a clinical trial and there are many
10:02reasons and I will go through many
10:04reasons differently and I I think
10:06covered some of them but in interest of
10:08time I will go uh one by one. Um so one
10:11is when you join a clinical trial this
10:13is your golden opportunity to get access
10:16to new treatment before that new
10:18treatment is actually even available in
10:21market. Typically there's a lag of about
10:233 to 5 years before a new treatment
10:27would be available by your doctor but it
10:30would be available through clinical
10:32trial. So five years earlier you could
10:34get a newer and a better treatment if
10:36you join a clinical trial. The second
10:38thing is clinical trial are also more
10:42use more targeted treatment that means
10:44whatever is the problem is what the new
10:47science is trying to target the disease
10:49problem. So typically we see the newer
10:51treatment are better than the previous
10:53traditional treatments like steroids and
10:55other and also as I explained you your
10:58standard of care your current
10:59medications are maintained throughout
11:01the clinical trial. So you don't really
11:03have a risk of having any major problem
11:05because you're already on the current
11:07treatment that your doctor would have
11:09normally given. And also um post-trial
11:13after the trial you have access to that
11:15treatment for longer period of time
11:18through various programs called open
11:20label extension in which the company
11:21says because this patient participated
11:23in clinical trial we will continue to
11:25give this drug if the patient wants to
11:27be on this drug.
11:29Then another benefit that comes from
11:32clinical trial that you may or may not
11:33have thought about is the clinical
11:36trials are require frequent checks and
11:40assessments and reviews of the patient.
11:42A normal clinical care you may see
11:44doctor once a month and uh maybe for 5
11:47minutes maybe for 10 minutes or 15
11:49minutes but in a clinical trial you're
11:51going to be with the doctors for an hour
11:53or more. So the amount of assessment and
11:57checks or understanding of disease the
11:59doctors can get during the clinical
12:02trial is very very high. Actually I know
12:05more much more about my clinical trial
12:07patient than my regular clinic patient
12:09because I'm with them a long time. I
12:11understand their disease better. I'm
12:13able to manage their disease better. So
12:15there are many many uh advantages from
12:18high quality care to high monitoring
12:20that comes in clinical trial.
12:22Third is empowerment and contribution.
12:25Because of you, a drug may be available
12:29in future for the whole generation of
12:32patients like you. So you're really um
12:34you know would could be the reason to
12:36advance science. You could be the reason
12:38who uh would actually help patients who
12:41with this conditions in future. So it's
12:43very rewarding actually to be able to uh
12:47be a person to lead to that discovery of
12:50a new treatment.
12:54And in meiocyitis specifically the
12:56clinical trials are very important. Why?
12:58Because myiocyitis is a rare and complex
13:01disease. As you know myioitis can cause
13:03weakness, rash and lung problems. And
13:05and basically our current care of
13:08meiocyitis. The current treatments are
13:10not good. That is why we want to do
13:13clinical trials with targeted treatment
13:15that can actually address the problem
13:18than the general treatment that we give
13:20right now. And the idea is that general
13:22treatment especially steroid brings in
13:24lot of side effects. These targeted
13:26treatment would not only get better
13:28control of the disease. We hope they
13:30also would have a much lesser side
13:32effects or problems.
13:35And um what it looks like to be in a
13:37trial. You get regular visits every few
13:39weeks or every month. You get blood
13:41test. You get examination. You get
13:43history taken by your doctors. Uh it's a
13:45lot more than a usual care. And also you
13:48have a full right to uh stop the study
13:51any point of time. So it's still you are
13:53in very much in control. Just because
13:56you you join a clinical trial doesn't
13:58mean you want to you will stay in a
13:59clinical trial. You can join a clinical
14:01trial and if it's not working or for
14:03whatever reason you have a full right to
14:05get out of the clinical trial without
14:07any problem.
14:09And also um when you when you join a
14:12clinical trial the doctor would talk to
14:13you about consent. they will explain you
14:15the risk and benefit. Um there is also
14:19oversight committees on the trial.
14:21Independent experts are reviewing your
14:23case on a regular basis. So there's
14:24somebody above even your doctor, even
14:27your institution to watch that
14:29everything is done correctly. Um and
14:31also myioitis India can help you with
14:33that information. So if you have a uh
14:36question or issues come up, we are
14:38always going to be there to help you
14:41apart from your doctors and institution
14:43where you joining the clinical trial.
14:46And then how how the progress is
14:48checked. How do we know the treatment is
14:50working? When you're in clinical trial,
14:51your doctors will regularly examine your
14:53muscles, skin, joints, uh do labs, we'll
14:56ask you how you doing and that's how we
14:58make sure that the the treatment is
15:00actually working when you're in a
15:02clinical trial.
15:04And also a lot of people are worried
15:05about cost. When you join a clinical
15:07trial, you don't have to pay for
15:09anything any test. You typically
15:12sometime your travel is also covered to
15:14come to the center. Sometimes your um
15:16you know hotel cost might be covered if
15:18you have to travel to a center and uh
15:20you know do a visit. So almost all costs
15:23are covered in most cases.
15:25What you should join uh ask before you
15:28join you should ask uh what's the goal
15:29of the study? What's the risk and
15:31benefit? Will I be able to continue my
15:33standard of care medication? How many
15:35visits would it require? How long does
15:37it take? Will I get the real drug after
15:39the trial? Are the cost covered? All of
15:42those things are good questions for you
15:44to ask. And how do you find a trial for
15:47myioitis u in my in India? At least you
15:50can just email or call myioitis India.
15:53Uh any vol one of the volunteers will
15:55help you to connect to the right
15:56clinical trial. But there are websites
15:58and and other areas where you can find a
16:01clinical trial that may be appropriate
16:03for you.
16:05Um so in in the end I just wanted to um
16:07thank you for listening and also um you
16:10know clinical trials are not like a
16:11voodoo science. It's actually a very
16:13very thoughtout process. Any drug coming
16:16to the clinical trial has already known
16:19to work in your disease. We're just
16:20having the final step of making sure
16:23this drug has everything um you know uh
16:26that we could release it in the market
16:28in a way. Um and there are many strong
16:30rules and the patient rights are always
16:32the first. Um so you are always going to
16:35be in control. Just by signing a consent
16:37doesn't mean you losing any control.
16:40Thank you.
16:44>> Thank you Dr. Rodal for this very
16:48interesting insight into how one can
16:50begin to understand clinical trials. Um
16:53if anyone has any questions please feel
16:55free to add them to the chat box. We
16:57will be happy to take them up and answer
16:59them to the ask them to the speakers. Uh
17:02for now we will begin with the next
17:04talk. Um and Simon can take over.
17:07>> Okay. So uh our next speaker is Dr. Fani
17:10Kumar uh who is an additional professor
17:12in the department of clinical immunology
17:14and rheumatology at NIMS Hyderabad. A
17:17prolific academic with 25 peer-reviewed
17:20publications and 10 textbook chapters.
17:22His expertise is grounded in deep
17:24clinical and research experience. His he
17:27specializes in complex inflammatory
17:29conditions including takayasuitis and
17:32inflammatory myioitis specifically
17:34anti-ynthetase syndrome and MDA5
17:36disease. Dr. Kumar brings extensive
17:39hands-on experience as a principal and
17:42co-principal investigator in clinical
17:44trials for rheumatoid arthritis, lupus
17:47and sclerodma. For today's session, he
17:50will bridge the gap between complex
17:52research and patient reality. Drawing
17:54from his work within the Indian clinical
17:56landscape, he will provide a
17:58step-by-step look at the patient journey
18:00within a trial, highlighting why local
18:03participation is vital to ensuring
18:05treatments are effective for Indian
18:08disease patterns and lifestyle. Over to
18:10you Dr. Fanny.
18:12>> Thank you for the introduction and uh I
18:14thank my India for this initiative
18:16because the patient centered programs
18:18and the clinical trials is a must in the
18:20need as told by professor Rohit. I think
18:23the medications in myioitis are meager
18:26and uh less studied and we need more and
18:29more targeted therapy. So I think uh
18:31clearing the myth of patients is very
18:33important for uh good recruitment and
18:35retention the clinical trials in
18:37myioitis. In the next 15 minutes I'll be
18:40talking about one of our patient journey
18:42myioidis clinical trial which is ongoing
18:45at our site and uh the next I will talk
18:47about how clinical trial proceed some
18:49insights already given by professor
18:51Rohit and I will talk about mainly the
18:53common misconceptions and what is the
18:55need for them in the end I will end the
18:58end my talk with our trial patient
19:00experience both pre-trial and into the
19:02trial when I counsel her
19:04so first I will talk about uh our own
19:07patient uh journey into the myioitis
19:09clinical train. We had a middle-aged
19:11female symptomatic from 2022. She came
19:14with joint pains severe with the muscle
19:17weakness in upper and lower limbs and
19:18she had rash or the face and she was
19:21already when she came to our center she
19:23was in highdose steroid and failed
19:25multiple therapies uh tried outside of
19:27our center and when we seen her in June
19:302024 we diagnosed her as antic syndrome
19:34Joe positive and by the time she
19:35developed a lot of steroid related
19:37adverse effect like she developed
19:39diabetes fatty liver disease and obesity
19:45And later I think uh in she had a
19:48disease flare in September 24 and we
19:50tried lot of combination therapies which
19:52are usually not approved but we tried
19:55them but she had stable for almost 6
19:58months later she had a disease flare
20:01where she had skin and muscle symptoms
20:03worsen. So later I think so wartness so
20:06I think after trying lot of medicine
20:07available so wness so then I think uh
20:10luck I think she had a we had a clinical
20:12trial at the same time approved with our
20:15center too so we just gave them an
20:17option counsel for the medication and
20:19clinical trial and she consented and at
20:22end of my presentation we'll talk with
20:24the patient with her experience at the
20:26end of my presentation so in the next
20:30few slides I will talk about how a
20:31clinical trial proceed. So whenever I
20:34think uh your doctor who is your
20:36treating physician sees you the case and
20:38there is a study going on in this
20:40particular disease. So when you when
20:42they feel that you are fit for it so
20:44they compare to see all the inclusion
20:46criteria what is the inclusion criteria.
20:48So which are because as said all the
20:50clinical trials are protocol based and
20:52they're strict in enrollment. So to have
20:55an uh equal enrollment across many
20:59centers. So, so they take the inclusion
21:01crit if they fill the inclusion criteria
21:03then your physician will connect with
21:05the study team. So if you are a good fit
21:10so what the study team do so study team
21:12will explain the study purpose benefits
21:14and any possible risk and we'll have
21:16enough time to think about it is not in
21:18a hurry type of thing. So I usually do
21:21in my clinical till whenever I enroll I
21:23give them an ample time maybe days to
21:26weeks to think about it to discuss their
21:28family when they can't take their
21:30opinion or or they can they can't
21:33confirm themselves. So this helps you to
21:35make an informed decision without any
21:37pressure. So at the end I think your
21:39comfort matters. We want you to fully
21:41understand the trial before you decide
21:43to participate. Take your time and we we
21:46every time invite questions. So to ask
21:48questions first and to have a proper
21:50communication before you agree and feel
21:52confident to go to the further process.
21:58So so you will receive a consent form in
22:01language you prefer. So in all the local
22:03languages are Hindi and English. Once
22:06you agree with the consent and
22:08everything. So once you agree to
22:10participate we record your informal
22:11consent on video. This is important. We
22:14take both audio and video consent. is
22:16important for transparency and proper
22:18documentation.
22:23Then it's screening. So when we first uh
22:25after the consent process done so the
22:28screening actors will be more of a
22:29demographic data. We take the medical
22:31and treatment history. We take the
22:33physical examination vital sense all the
22:35lab investigations. We also see the what
22:37is the standard of care already patient
22:39is taking at present and we go with the
22:42different disease acted assessment. So
22:44which is mandatory and we follow with
22:46the trial drug also how you are doing
22:48over time and we take the patient report
22:50outcome questions which are quality of
22:52life. So it is most of is one of the end
22:54point for most of the studies.
23:00Then I think this part I think I feel
23:02most of them have lot of queries in it.
23:04So what is this randomization? So
23:08randomization is something it is a
23:10proper controlled studies to keep the
23:12selection bias less and less
23:14confounding. So this randomization means
23:17that doctor doesn't choose your group.
23:18So where you fall? So you may fall into
23:21treatment group or you fall into a
23:23placebo group where you do you get a
23:25dummy instead of the study drug and we
23:28see the outcome measurement at at
23:30whatever the stipulated. So most of the
23:33studies do one year study. So till one
23:36year you'll be either getting a
23:38treatment or a placebo.
23:42So later I think once the randomization
23:44is complete you get a study medicine and
23:47instructions. So how to use it and you
23:49have followup visits. So it all depends
23:51because as said safety is very important
23:54part. So the earlier visits will be very
23:56short and the later wheels will be far.
23:59So as you do well so but it's all
24:01protocol based nothing to change it or
24:05accordingly to each individual patient.
24:07So you have health checks at each
24:08followup visit. You have blood test and
24:10you have repeated questions being
24:12repeated every time to see how the drug
24:14working on you and you have a safety
24:17track throughout the trial.
24:22So as said I think all the trials are
24:25under regulatory because if you go to
24:27any country they have their own
24:28regulatory body who will control any
24:31clinical trial conducting in their
24:32country itself. So coming to India I
24:34think uh all clinical trials must be
24:37documented in the clinical trial
24:38registry India and the most common uh I
24:41think the biggest body which takes as a
24:44regulator that is a CIS school and DCJ
24:46is the final approving authority and
24:48this organizable to the ministry of
24:51health and family welfare. So it all
24:52goes with a very stricter rules. So I
24:54think not that the investing contracts
24:57are given so they are all with the
24:58regulatory process.
25:00Next slide.
25:03So I I think in my last decade I think
25:07uh enrolling patients into clinical of
25:09different romatic diseases I feel
25:11whenever I counel for a clinical trial I
25:12hear lot of apprehension. So the first
25:14question I hear is is safe tested
25:17whether it is tested first one the fear
25:19perception the first one makes them
25:22uncomfortable. So I think I take time to
25:24talk about this and the second is the
25:26drug tested before in this condition and
25:29what happens if any side effects how
25:30they will be tackled.
25:34So as uh shown in this uh slide so you
25:37see any investigational drug goes
25:39through a rigorous process of in
25:41development in the preclinical either on
25:44cellular basis or in animals. Then they
25:46go to phase one which is on a human
25:48study where 20 to 80 people are studied
25:50which are healthy volunteers or disease
25:52people and phase two is all about safety
25:54and effectiveness in a small group of
25:57patient and the phase three is into
25:59thousands of patient multi-institutional
26:01and multi-country studies. So they all
26:04concentrate on safety and effectiveness
26:06once I think the approval process gets
26:08after the phase three results it goes to
26:11phase four. So this all all being
26:13reported because after they get marketed
26:15also the long-term surveillance
26:16continues for any drug. So the
26:18misconceptions I think clinical trials
26:20aren't safe. So as I said they have
26:22strict safety protocols and reviewed by
26:25ethics board to protect patients and as
26:28I said I think in the professor Rohit
26:29talk also I think they are expensive but
26:32people say who will pay I think these
26:34are common questions I hear about it. So
26:36all the trial related processes the
26:38travel the everything will be any safety
26:41issue happening within the trial either
26:44an admission required or any adverse
26:46effect happening. So everything will be
26:47taken care by the either the trial
26:49insurance or the sponsor.
26:53So then the next chapter I hear is can I
26:55come out of the trial if a person or it
26:57is must to stay till trial ends as I
27:00think it is again recap the same point
27:03made by professor Rohit. I think uh no
27:05one will be tied into the trial. So I
27:08think it all is a voluntary informed
27:10consent. So at any point you can come
27:13out of the trial. So if if I think if a
27:15wor in the trial I think it is a
27:17treating patient who will decide if you
27:19think it is due to the drug and they
27:21decide not to give the drug and go with
27:23an other options of treatment as a
27:25regular care and like get operations
27:27about injectable drug and oral drug and
27:29I feel oral drug people give concern
27:32soon and they have mis conception that
27:34injectable drug has more side effects
27:36than oral drug which is not and any
27:38scale drug I think for safety is first
27:40so they'll be monitored so both I think
27:42either of it for a clinical control is
27:44equal. So is a trial drug cure my
27:47disease. So as understand for any
27:49rheumatic disease I think we talk about
27:51the control than the cure. So I think
27:53whenever I say about the trial drug the
27:56first the other question comes is
27:57curable. So I don't think any disase
27:59curable. So it may boast effective
28:01treatment as more targeted than the
28:04imosception which are used as standard
28:06of care. So then the next question comes
28:08if I get placible when I talk about
28:10randomization if they get placible what
28:12is my benefit in participating in trial.
28:16So then then I I say them uh so I think
28:20every phase I think the first phase of
28:22the study will be randomized study later
28:24will be an open label extension study.
28:27So even if you get plaso in the random
28:29phase then you'll be able to get the
28:31study drug in the open label extension.
28:33So I think they will get the real drug
28:35after the randomation period. So the
28:37main misconceptions here I think it will
28:40be time consuming and inconvenient as
28:42said by professor dohit I think the care
28:44will be much better and will be given
28:46more time by the study team and the
28:48treating physician every visit and
28:50knowing your disease perfectly at each
28:52visit with the different questionates.
28:54So you'll be more high quality care you
28:56will be provided and as I said it will
28:58not be out of your control and it is all
29:00voluntary to continue in the trial and
29:03you can exit the trial at any point of
29:05time.
29:09So your rights and what to expect. So
29:11you can leave anytime no cost for study
29:13medicine. Your privacy is protected and
29:17uh and any questions hold during the
29:20study period will be will be answered by
29:22your treating physician the study team
29:24at any point of time.
29:30So what is the need? I think this part I
29:32think professor Rohit has covered. So I
29:33think as as I said I think treatment the
29:36novel treatment takes time to again get
29:39approved and marketed. So you get a
29:41chance to get the drug keeping your
29:43disease under better control and you are
29:46advancing science so that you are we can
29:48find treatments for new diseases so it
29:52will decrease the health cost later and
29:54it can be better understanding the
29:56science and you have you will be helping
29:58the other peers so other patients of the
30:00same disease over time that I think the
30:03study drug can be given to them over
30:04time after approval.
30:08So with this I think I will uh ask the
30:10back end team to unmute uh Miss X. So so
30:14that I think I will ask her experience
30:16in the train with the questions shown on
30:19the slide. So the first question so I
30:21will try to keep it in uh English but
30:24she's comfortable in our local language.
30:26So I will translate you for the rest of
30:28the audience. So the first question to
30:30her is why did she decide to join
30:32clinical trial?
30:51join.
30:53Okay. So I think to translate I think uh
30:56she said I think she used lot of
30:58medication and her disease is
30:59refractive. So she when we gave this
31:02option so she thought it is a targeted
31:05treatment and effective. So then she
31:07decided to join the clinical trial. So
31:09the next question to her uh were there
31:11any apprehension or hesitation from your
31:14side?
31:28starting.
31:35Yeah.
31:40Yeah. So I think uh uh so what she says
31:44is I think her apprehensions initially
31:46with the injectable drug and everything
31:48she has it in before the study and I
31:51think as more and more communication
31:53with the study team and the treating
31:54physician and her apprehensions has over
31:57time I think they got settled.
32:00So what is your experience in the trial
32:02so far?
32:13Okay.
32:16So her experience in the trial so far is
32:19gratifying. So she says uh at the
32:22beginning of the study she has muzzle
32:24weakness and joint pain. Now everything
32:27is settling out and she's happy with the
32:29trial medication.
32:32So do you think you you have the took
32:35the right decision by joining the
32:36clinical trial?
32:44>> Yeah. So she feels that I think after
32:47the gratifying response everything she
32:49had so she feels she took a right
32:51decision by joining the clinical tri.
32:54Thank you. Thank you for your uh inputs.
32:57Yeah. Thank you I think for giving this
33:00opportunity. So happy to take questions.
33:05>> Thank you for the very interesting talk
33:07Dr. Sani S. We really liked how complex
33:10concepts such as the inclusion and the
33:12exclusion criteria and the randomization
33:13were explained so simply and the
33:15interactive session with a real patient
33:16at the end. Um we will be taking
33:19questions in the Q&A round after the
33:22third talk. Uh thank you for your talk.
33:24>> Thank you. Yeah.
33:25>> Uh our next speaker is Dr. Anushka
33:27Agraal. She is a rheatologist trained at
33:29Indrust Abola Hospital, New Delhi with
33:32focused clinical and research experience
33:34in idiopathic inflammatory myopathies
33:37and myioitis myioitis related lung
33:39diseases. She has been actively involved
33:42with myioitis India in academic and
33:44administrative roles reflecting her
33:46commitment to patient centric education
33:48and advocacy. Her work spans
33:51participation in international meioitis
33:53research collaborations and fellowships
33:55at leading meioitis centers such as the
33:57University of Pittsburgh Medical Center
33:59USA and the Dutch Myioitis Group. For
34:03today's session, she brings the combined
34:05perspective of a clinician and patient
34:07advocacy leader to the role of Myioitis
34:10India in helping patients understand the
34:12clinical trials. Over to you Dr.
34:14Anushka.
34:15>> Uh thank you Myioitis India for giving
34:17me this opportunity. uh I would like to
34:20discuss the final topic for this event
34:24today on how how myioitis India can help
34:27you. So basically I think in the last
34:30two uh talks you have heard of what a
34:33clinical trial is what happens in a
34:35clinical trial. How a clinical trial
34:38identifies good medicines that are not
34:40available on the market and makes them
34:42accessible to patients who are not doing
34:45so well on current treatment. I can
34:47understand that there are lot of medical
34:49terms, lot of new information that can
34:51be overwhelming for someone who has
34:53heard about the disease for the first
34:55time and is experiencing it. So that is
34:58where myioitis India comes into play. We
35:01help you understand your disease. We
35:03help you understand your treatment
35:05options. We help you understand what the
35:08new drug is, how you can use it, how it
35:11will benefit you. And if you want to we
35:14try to connect you to the nearest
35:16clinical trial centers or investigators
35:19who are doing clinical trials on your uh
35:22disease. Next slide please. So basically
35:25we can be your bridge. We can be your
35:27bridge in understanding how your disease
35:29is progressing and how we can better
35:32treat your disease and help you get
35:34better. Next slide please.
35:37So as we have understood so far clinical
35:40research goes through multiple steps
35:42which start with analysis in very uh
35:45animal models and then there are a lot
35:47of studies before the drug comes out to
35:51the patient in clinical trials. They
35:52have been studied in other patients in
35:55other regions in other countries and
35:57when the drug is found to be effective
35:59only then a clinical trial of this scale
36:02is done to see how it is responding to
36:05patients in India. As we mostly know,
36:08most of the drugs that undergo clinical
36:11trials in India have already been
36:13studied in multiple countries like USA,
36:16United Kingdom and Germany and other
36:18countries and have been found to be
36:20effective. But their results cannot be
36:24used on the Indian population because we
36:26are different. Our genetic makeup is
36:28different. Our diet is different. Our
36:30environmental exposures are different.
36:32So for a drug to be available in the
36:35Indian market, it has to be found to be
36:37effective on Indian patients. So it does
36:40not mean that undergoing a clinical
36:42trial, the drug is being tested on you
36:44for the first time. It has been tested
36:46in multiple people in multiple different
36:49genetic makeups, different geographies
36:51and found to be effective. Hence a
36:53similar study is being done in India in
36:56Indian patients. So coming to trial
36:58information, how can myioitis India
37:01help? Now we with this webinar we have
37:03answered the question of what is a
37:05clinical trial. The second question that
37:07comes is what will happen to me? What
37:10will be done in the clinical trial that
37:12Dr. Fanny has nicely explained the
37:15treatments the procedures and the
37:16timelines of the trial and what does it
37:19mean for me in the future. If you get
37:21the drug in phase one and you improve
37:24then you are continued on the drug and
37:26you are doing well. If you get the
37:28placebo in phase one, then you will get
37:30the drug in phase two. When phase one
37:32completes, if for some reason you
37:35develop some side effect through the
37:37medicine or the medicine does not work
37:39for you, then you will still be on your
37:42current standard therapy and that will
37:44still be effective for you and you are
37:46free to exit the clinical trial if you
37:49feel you do not want to continue
37:51further. And all this info for Indian
37:54trials can be found out on the clinical
37:57trials registry for India. The link to
37:59the website you can see in the slide. So
38:04how myioitis India plays a role in this?
38:06There can be three scenarios where
38:08myioitis India can help you. In the
38:11first scenario, a patient like any one
38:13of you will come to myioitis India to
38:16know about the active trials. I can see
38:18a number of questions in the chat box
38:20where people are having a disease. They
38:22are on treatment but they are not doing
38:24well. So they want to know what other
38:26options they have. We can help you with
38:29a list of currently active clinical
38:31trial centers. We can facilitate
38:33referral to centers or investigators in
38:36India who are involved in clinical
38:38trials in myioitis.
38:41uh apart from that if you find a
38:43clinical trial that might be good for
38:46you or you are fulfilling the inclusion
38:49criteria for that clinical trial then we
38:51can offer trial support. That means
38:54understanding the consent forms,
38:56understanding the medical jargon,
38:58understanding the rules and the
38:59regulations, how the treatments will
39:01benefit you, what are the possible side
39:03effects and understanding timeline and
39:06many other questions which you may think
39:08of that are coming to your mind. We also
39:11help patients ask the correct questions
39:13to the investigators to understand their
39:16trial eligibility. Like Dr. Rohit
39:18Agarwal mentioned, you should know what
39:20to ask a investigator before enrolling
39:22in a trial so that you can extract all
39:25the information from the investigator
39:27regarding that trial before enrolling.
39:30Next, please.
39:34And at the same time we can help you
39:36connect to other patients who may have
39:39experienced clinical trial in apartments
39:41environments in the past like the
39:43patient who just shared her experience
39:45who has been enrolled in a clinical
39:47trial with Dr. Fenny. We can help you
39:49understand and connect with these
39:51patients so that you can also get a
39:53patient's experience and their point of
39:56view on how they are doing in a clinical
39:58trial.
39:59Next slide please. So this was the first
40:01scenario in which a patient comes to
40:04myioitis India to understand if there is
40:08a clinical trial that is suited for him.
40:11The next comes guiding patients who have
40:13been offered enrollment. That means if a
40:16patient who is not doing so well has
40:18been offered that there is a clinical
40:20trial that their doctor thinks will be
40:22good for them and they can enroll into
40:24that clinical trial. The medicine is
40:26supposed to be beneficial for them. So
40:28we can answer some questions which they
40:30might be hesitating in asking their own
40:32doctors. We can provide them with
40:34additional information regarding that
40:36clinical trial which is otherwise
40:38publicly available on major platforms.
40:42So we can them understand their roles
40:44and commitments. We can always offer
40:47them trial support. We can un help them
40:49understand what their treating doctor is
40:51expecting from them if they join a
40:54clinical trial. How the drug might
40:56benefit for them. what other options do
40:58they have in case they don't want to
41:00join the clinical trial.
41:03We can also help them understand how
41:05treatment protocols will change and what
41:08effects the drug will have on their
41:10health. Will they be able to reduce
41:11their medications? Will the treatment
41:14prevent their disease from progressing
41:16and stabilize their symptoms but they
41:18will still have to continue medications
41:20that they are already continuing or will
41:22they be able to reduce the dose and stop
41:25medication at some time. All these
41:27questions are valid and we help you
41:30understand them better. We can always
41:32help you in connecting to other patients
41:35who have experienced clinical trial
41:37environments for better understanding.
41:39So after these two scenarios there is a
41:42third scenario in which the patient does
41:45not directly come to us but the doctors
41:48come to us looking for options for their
41:50patients. We as we know myioitis is not
41:53a disease at this point of time which
41:56can be cured. It can only be managed
41:58with medications and physiootherapy so
42:01that patients do well and are able to
42:03have a good quality of life. But there
42:06are still some patients who will have a
42:09severe disease which is not responding
42:11to medications. Everything has been done
42:13but the disease is continuously
42:15progressing. In those cases sometimes
42:17doctors may also approach myioitis India
42:20to look for other options for their
42:22patients or for any active clinical
42:25trials that the that are currently
42:27enrolling. So similarly we can help the
42:30doctors to find the correct centers and
42:33investigators in India who are involved
42:35in these myioasitis trials and then with
42:38the help of the doctors the patients can
42:40be enrolled in those trials if they fit
42:43the inclusion criteria. I would like to
42:46emphasize here that not every patient
42:48can enroll into a clinical trial. There
42:51are some criterias, there are some
42:53stages of disease that the patient
42:55should be in before enrolling into
42:57clinical trials.
42:59We also help the patient and the
43:01physician correct connect to the nearest
43:04stakeholder or the nearest institution
43:07which is conducting a clinical trial so
43:09that even the physician is uptodated
43:12about their patients care and the
43:14physician can be a part of the
43:16decision-m process.
43:19So myioitis India is available to help
43:22patients with all informations that is
43:25related to the myioitis treatment
43:27options whether they are clinical
43:29trials, non-clinical trials, drugs that
43:31are already available in the market or
43:34any medication that the patient feels
43:36can be used. We are here to help you
43:39guide whether they will benefit you or
43:41not. But we will not be a treating
43:43doctors. We are just a support system to
43:46give you the right knowledge so that you
43:48can make an informed decision. We you
43:51can contact us through any of these
43:53portals. You can scan this QR code and
43:56then it will give you ways in which you
43:59can contact us. You can directly call or
44:02WhatsApp us on the number shown or you
44:04can WhatsApp you can message us through
44:06Twitter, Instagram or Facebook or
44:09YouTube.
44:11Thank you for listening.
44:14We're happy to take any questions now.
44:16>> Thank you so much Dr. Anushka. That was
44:18a really good insight into what actually
44:20goes on into how a patient suffering
44:23from acetis can approach a person who is
44:24doing a clinical trial. Um we will now
44:27be beginning with the question and
44:28answer session. A notification to
44:30everyone. If you have a question and you
44:32want to speak and cannot type, please
44:34raise your hand in the zoom app. We will
44:37be happy to unmute you. Before that, we
44:39already have a list of questions we
44:41received from patients. Uh we have two
44:43patients asking a question about the
44:45drug. Can you please explain how an
44:47imunosuppressant works and what is the
44:48difference between an imunosuppressant
44:50and an immune system regulator? How does
44:51that affect myioitis? Dr. Anushka please
44:55if you can.
44:56>> Okay. Okay. So the question is for me uh
44:58definitely immunosuppressant and immunom
45:01modulators are medications that are on a
45:04spectrum. Immunosuppressant is we say
45:07something that is a strong medication
45:09that will suppress some amount of good
45:12immunity along with the bad immunity.
45:14While it is trying to control your bad
45:16immunity, it will suppress some amount
45:19of good immunity which will make you
45:21sensitive to side effects. So an
45:23imunosuppressant is something like a
45:25steroid. Steroid is an imunosuppressant.
45:27When steroids are used in high doses,
45:30they suppress the bad immunity but they
45:32also have certain side effects. uh with
45:35apart from that immuno regulators are
45:38targeted medicines. Immunore regulators
45:40do not suppress the whole immune system.
45:44They are medicines which act on one
45:46pathway or one molecule and they block
45:49that molecule. So they help in uh
45:52improvement of the disease and
45:53improvement of the symptoms with very
45:55less side effects as compared to
45:57imunosuppressants. So in imunom
45:59modulators retoximab is an immunom
46:02modulator or also jack inhibitors that
46:05is tophacetanib is an imunomodulator
46:08they also have side effects it's not
46:10that they are completely safe but they
46:12are safer than the imunosuppressants
46:15>> also uh Anushka I want to mention um
46:17there are the current clinical trials
46:20are always going to be on more targeted
46:23or newer uh therapies which are more
46:26targeted instead of suppressing the
46:28whole immune system they suppress very
46:31small part of immune system the part
46:33that is causing the problem that is why
46:36newer treatment seems to be safer um so
46:40for example drugs like jack inhibitor
46:42andimab uh retimab or newer agents like
46:47uh interfron beta blockers um those are
46:50more specific uh to me myioitis so what
46:55happens is because you're blocking a
46:56small part of immune system which is
46:58causing the disease. It leads to less
47:01side effects. So that's another
47:03advantage of being in clinical trial
47:05because these drugs otherwise may not be
47:07clinically available.
47:09Okay, next question.
47:12>> So the next question was what happens if
47:14something bad happens to me in a
47:16clinical trial? Would insurance or
47:17medica cover it?
47:20>> That's a very good point. So typically
47:23if there is a problem in the clinical
47:25trial it is to be covered by the
47:28clinical trial. So for example if it's
47:32related to clinical trial it would be
47:33covered by clinical trial. But let's say
47:36something happened that is not related
47:37to clinical trial. For example you had
47:40an accident uh and you had a medical
47:42problem because of accident while you
47:44were in clinical trial that would not be
47:46covered by the clinical trial. So it's
47:48very common sense if there is a side
47:50effects from the clinical trial then the
47:52your doctor and your medical team would
47:55uh you know would take care of it as a
47:58part of your clinical care and clinical
48:00trial. So it would be no different for
48:03you in terms of the claim or or anything
48:06most part would be covered by the trial
48:07but if it's not thought to be not
48:09related it'll be covered by your your
48:11regular medical care.
48:13>> Yeah. Hi my name is Vikram Marura. I am
48:16staying in Gurango. So I have been
48:19through four rounds of IVIG in 2024 with
48:23absolutely no improvement in my
48:25condition of inclusion body myioitis.
48:28So I have lost about 30 kgs of muscle
48:30mass in the past uh 3 to four years more
48:34rapidly in the last two years and I'm
48:37presently at 60 kgs. Now
48:40should I go in for some treatment first?
48:42Can I see Dr. Anushka Agarwal in Delhi
48:46first and then take the course forward.
48:48Please advise.
48:49>> So that's a good question. I'm going to
48:51let Anushka speak about how they can be
48:54in touch with you. But um the inclusion
48:57body myioitis actually had couple of
49:01clinical trials ongoing last year or so.
49:04uh but right now those clinical trials
49:07are uh closed uh for enrollment even in
49:10US and in India we have not been able to
49:13open any clinical trial in inclusion
49:16body myioitis or IBM. In future we are
49:19working in myioitis India to help our
49:22myio inclusion body myioitis patient by
49:25offering clinical trials in India. Um in
49:28terms of your specific case, I think I
49:31agree you should see a rheatologist or a
49:33neurologist and be in a regular care. Um
49:37but I would have to say there are not
49:39that many options in currently available
49:42in IBM or inclusion body myioid. Anushka
49:45could you guide him how he can be in
49:47touch with you and have an evaluation?
49:51>> Yes sure uh Mr. Dr. Vikram you can drop
49:55a message to myasitis India and they
49:57will help fix uh an appointment for you
50:00with me. Right now I am actually working
50:02in Noida. So if that will be helpful for
50:04you, you can travel to Noa or we can
50:06even do an online consultation. Myitis
50:08India will help you get in touch with
50:10me.
50:11>> Yeah Mr. Vikram actually the best way to
50:13do would be to contact myasitis India.
50:16We could do sometimes a review session
50:19with you and find the right doctor near
50:22you who would know myioitis. So we can
50:26refer you to the appropriate doctor if
50:27Anushka is far for you.
50:30>> Yeah. So my name is Sai Kumar. I am
50:32Syasa's husband. So I want to talk with
50:36Dr. Fani Kumar.
50:37>> Yeah you can go ahead. Yeah sir.
50:39Namaskarum.
50:41So actually
50:5036 years. So papa
50:54poly.
50:57So
51:07any
51:14appointment.
51:17So later on
51:40we will do that.
51:42Any particular question regarding
51:44clinical trialsinical
51:46trials
51:52first you said about RA with polyioetis
51:55for that time I think we don't have I
51:57think for overlap cases I think we don't
52:00have any inclusion in any clinical trail
52:01for the present
52:03>> but for your care of polymers you can
52:05meet meet us I think may not be may not
52:08be suitable for a clinical trail for
52:10that time
52:11>> okay okay whatever We are having nose I
52:13think
52:14>> but also
52:16>> Fanny but also sometimes we see people
52:18get diagnosed with rheumatoid
52:20>> because of polyarthritis related to
52:22myioitis. So
52:24>> I always try to evaluate a patient even
52:27if they sound overlap.
52:28>> Agreed.
52:29>> You may want to evaluate to see if their
52:31myioitis might be the main one and RA
52:34was more like myioitis related
52:36arthritis.
52:37>> Yes sir. Agreed. Yeah.
52:38>> So yeah.
52:40>> Yes. Uh uh this is Reema. I'm going
52:43through IBM since 8 years and I'm on
52:45predence alone 7.5 mg.
52:49Um can you am I audible?
52:52>> Yes. Yes, you are.
52:53>> Yes. Yes.
52:55uh so I was um wanted to know that
52:58should I go under imunosuppressants to
53:01reduce my predinis alone because uh
53:04predinis loone has got a lot of side
53:06effects and also I would like to should
53:08I be consulting a neurologist or
53:10rheumatologist because right now I'm
53:13under a neurologist
53:14>> and is it possible to uh consult Dr.
53:18Rohit Agarwal or Dr. Kal because I'd
53:21love to do that and I want to
53:22participate in the clinical trial as
53:24well.
53:26>> So they're very good questions. I'm
53:27going to quickly answer each one of
53:29them. Um so you were on steroid but um
53:32whether to answer whether you you should
53:34get on imunosuppressive drugs or
53:36non-steroid drugs is very difficult
53:39without knowing your case. So I think
53:41what you should do is probably the best
53:43step is to write to myioitis India where
53:46you can have a support session with
53:48myioitis India team and volunteers and
53:50doctors and then they can guide you what
53:52would be the next best step to get it
53:54evaluated. So that's one thing and the
53:57second thing is there are no clinical
53:58trials in IBM in my in India. There are
54:02clinical trials in dermaromyioitis.
54:04There are clinical trials in
54:05polymyioitis, anti-synthesis syndrome,
54:07Im&M and many other myioitis but not in
54:10IBM right now and you could also talk to
54:13me through myioitis India as well. Um
54:16and um yeah you're right steroid has a
54:19lot of side effects. We like patients to
54:21get off of it or or get to the lowest
54:24dose if possible. And in terms of
54:26neurologist versus rheumatologist, both
54:28doctors are actually well equipped to
54:31manage myioitis. In India, mostly I see
54:34rheumatologist manage myioitis, but some
54:37neurologists are also excellent care
54:39provide excellent care in myioitis. So
54:42that's really up to you.
54:44>> So is it possible to doctor consult Dr.
54:47Rohit Agarwal? I think he's a
54:48rheumatologist.
54:50>> Yes, you you can
54:51>> I want to know go to one of the best
54:53ones that's why.
54:55>> Okay. Best is to contact myioitis India
54:57for initial uh review. That would help
55:01them to guide you in the right
55:02direction.
55:03>> Okay. Does Dr. Rohital practice in India
55:06or is only in the US?
55:07>> No. No. I do not practice in India. I
55:09practice in US. But I can guide you to
55:12the right.
55:13>> Yeah. But there are lot of good online
55:16consultation with you. We can we can
55:18talk about it through my India. I think
55:20we need to um yeah we why don't you
55:23contact my India for one-on-one session
55:26that would be helpful.
55:27>> So I I would get an consultation with
55:29you through my service. Yeah.
55:31>> Yes. Thank you for your question. Next
55:34question in the interest of time please
55:36go ahead. Yes. Yes.
55:38>> Hi this is Ashish. I uh I have been
55:41diagnosed with overlap myioitis in the
55:43year 2024 and I have been taking the
55:47medicine from surya praba ma'am in the
55:49nims hospital hydroad sir funny sir
55:53actually
55:54>> yeah you're audible
55:55>> yeah I'm yeah I'm using these tablets
55:58like vison 5 mg and your brain 50 mg so
56:04I I do have the like pains and all like
56:07I can't stand um more than 30 minutes
56:10and I do have back pain even after using
56:14those tablets from uh I think one and a
56:17half year like that. So up to how much
56:20time should I continue those tablets
56:22like that is my question sir
56:27>> I think you are following with the
56:28neurologist right so I think
56:29>> yes yes sir yes sir
56:30>> you're following with the neurologist
56:31>> yeah yeah head of the department I think
56:33>> yeah I think you can meet her because if
56:35your disease is ongoing I think she
56:38should be better judged to escalate your
56:39therapy if needed
56:41>> yes sir
56:42>> yeah it is very difficult for us to give
56:44you medical advice on a forum like this
56:46you know you can either see your
56:48neurologist, see Dr. Fanny or get help
56:51from ISIS is India but we cannot discuss
56:53like you know without knowing the whole
56:55case here
56:56>> like yeah yeah is there any possible to
56:58meet anumar sir or I continue with the
57:01surra ma'am
57:03>> either way because wherever you feel
57:04comfortable
57:04>> either way
57:05>> either way
57:06>> yeah see your doctor choice is patient's
57:09choice so you have to decide we cannot
57:12uh you know
57:13>> yeah like she's she's neurologist but
57:16sir is rheatologist I think that's why
57:18I'm asking the
57:22both doctors
57:23>> it's a common area so both both treat so
57:26I think uh wherever you feel comfortable
57:28you can go ahead
57:29>> yeah yeah sir like sorry to ask this
57:31also like is there any particular cause
57:33for this disorder to come
57:38like a
57:39>> it's an autoimmune disease so your own
57:41immune system for some reason start to
57:43attack your own body there is no
57:45particular cause
57:46>> yeah okay Yeah,
57:50>> thank you for question. Thank you. Can
57:53you please unmute yourself and go on
57:56sir sir
57:59sir
58:17Sir continue. MMA 500
58:213 2
58:241 2
58:28IMG sit
58:33evening
58:34physapy 1 hour
58:48further any trial comes I think we'll
58:49inform you again.
58:59>> I think I I'll get back to you because
59:02contact will get back to you.
59:04>> Thank you Baskar Gupta. Can you please
59:06go ahead? I I've been detected with uh
59:11termatocitis associated with antiMDA5
59:14and further uh rapidly progressive
59:19since April 25
59:21and uh just wanted to know that
59:23presently I am on uh uh predisolon
59:27rettoximab which was is being given
59:29every 6 months uh IVIG a monthly dose
59:33and to sitanib so wanted to know this uh
59:36since my rematlogologist have been
59:37saying that this is a one of the rare
59:39diseases. Is any clinical trials going
59:41on uh with myasitis India?
59:43>> Yeah, I can address I can address that
59:46actually your disease is is of one of
59:49the severe kind NTMDF5 and it's one of
59:52the rare kind and actually uh if your
59:55disease is still active you will be well
59:57suited for clinical trial. So my advice
1:00:00to you would be but we cannot decide
1:00:02your case on a call right we have to
1:00:05evaluate you as Dr. Fanny explained we
1:00:08have to get two of you to the right
1:00:09center then right center will do the
1:00:12screening test to see if you are
1:00:13eligible for the trial. So all of those
1:00:16things have to happen. So contact my
1:00:18India if you're interested in clinical
1:00:20trials and we will guide you to the
1:00:22right place where based on your where
1:00:26you live we'll guide you to the right
1:00:28doctor and the right center.
1:00:31>> Okay. Thank you.
1:00:33>> Thank you. Now we have a question from
1:00:34Prashad. So please go ahead sir. So I I
1:00:36just want to also say that uh Maria that
1:00:39anybody who's interested in uh getting
1:00:41evaluated through for my for clinical
1:00:43trial can either can contact myiosetis
1:00:46India and we will try to find the right
1:00:48uh doctor and right center for you. Um
1:00:51and also for any other clinical care
1:00:54questions you can also write to my India
1:00:57where what we do is a quick session with
1:00:59you and then put you to the right
1:01:01connect you to the right doctor and the
1:01:03right center for for the right path.
1:01:06Absolutely. Thank you for clarifying
1:01:08that. For all the attendees, we have
1:01:10included all the links of Myioitis India
1:01:13and the phone number and the email. If
1:01:15you have any questions, any clinical
1:01:16queries and any clinical trial queries,
1:01:18we will be happy to answer them. Please
1:01:20reach out to us through the mentioned
1:01:21contacts. Prashant go
1:01:25namaskar sir. Uh sir questions
1:01:29basically
1:01:31participate
1:01:40whether it will become a ground for
1:01:42rejection of my further medic
1:01:49after the process.
1:01:51>> Okay let me answer and maybe Fanny you
1:01:53could also help here. So in my
1:01:55understanding the when you join the
1:01:58clinical trial that part is totally
1:02:00covered after the clinical trial is a
1:02:02usual care so that any drug doesn't have
1:02:06a longlasting effect. So after the
1:02:08clinical trial your medic claim and
1:02:10everything should run as usual as it was
1:02:13before and during the clinical trial it
1:02:15will be covered through the clinical
1:02:17trial. your your your your trial related
1:02:21cost will be covered through that but if
1:02:23other cost would be covered through your
1:02:24regular claim right Fanny.
1:02:26>> Yes sir. Yes sir. I think. Yeah.
1:02:28>> So there should not be any difference.
1:02:31>> I think with the with the
1:02:34>> with the regulatory in India with the
1:02:36insurance with the term insurance I
1:02:39think if you are into the trial even if
1:02:40any damage happens after the after the
1:02:44what do you say if you take the
1:02:45insurance policy for that year I think
1:02:48they get the payout for that insurance
1:02:50too. For the health insurance I think as
1:02:53said I think it is covered by the trial
1:02:54insurance. I think pause the trial. I
1:02:57think any trial I think should be
1:02:58disclosed at the start whenever you take
1:03:00a insurance. So I think that should be
1:03:02important. I think you can't disclose in
1:03:04between two.
1:03:07>> But sir, actually our policy is a
1:03:09pre-existing policies. No.
1:03:11>> So now declaration will be a
1:03:14problematic. Now declaration is a
1:03:15problematic. It it will be possible only
1:03:17at the time of renewal only.
1:03:19>> Yeah. Yeah. Yeah. That is true. I think
1:03:21it is in the in the year. I think it no
1:03:23issue with the payouts later.
1:03:27>> Yeah, we haven't heard any issues with
1:03:28the payouts Pashan G for for insurance
1:03:31issues.
1:03:32>> Yes.
1:03:37Right. There are many clinical trials
1:03:40Prashant Gi one minute. There are many
1:03:41clinical trials going on in India and
1:03:44there has not been any issues or event
1:03:46where the insurance was denied due to
1:03:48clinical trials. That's not happens.
1:03:50doesn't happen usually.
1:03:54>> So that will be the great so
1:03:59and I will try to
1:04:06and sir.
1:04:08>> Thank you very much. Any other question?
1:04:12Should we close or do you have any?
1:04:14>> We have one last question from Krishna.
1:04:16Apart from that there are no additional
1:04:17questions. Please go Krishna.
1:04:21Good evening.
1:04:22>> Yeah. Good evening.
1:04:27>> Yeah.
1:04:39come.
1:04:40>> Okay. Yeah. Yeah. You can come. I think
1:04:43uh yeah, you can you can come and meet
1:04:45our trial team. So I think we already
1:04:47had that discussion.
1:04:49>> Okay.
1:05:00as well.
1:05:04>> Thank you.
1:05:05>> I have one last question from Shali then
1:05:08we will end. Please go ahead Shali. Uh
1:05:10hi uh I am Shali and it's been two year
1:05:13that I'm suffering from uh damma
1:05:16myioitis overlap uh syndrome like SSC
1:05:20and I'm doing good with the traditional
1:05:22medicines and uh my steroid is
1:05:25completely stopped and I only take it
1:05:27when I get the flare-ups when I uh when
1:05:30I'm sick like I uh get the viral
1:05:33infection or something like like that
1:05:36and uh if in this situation
1:05:39I want to proceed with the functional
1:05:41medicine. So I want to know uh can I get
1:05:44the good results uh from the functional
1:05:46medicines.
1:05:47>> What do you mean by functional medicine?
1:05:51>> Uh because uh I heard that and also
1:05:53research that they work on the root
1:05:55cause like environmental factors your uh
1:05:58gut microbiota and uh uh and they run
1:06:03with the several tests
1:06:05>> like having
1:06:07Yeah. So I think from I can be very
1:06:09clear to you about from myioitis.
1:06:11Currently there are no traditional or
1:06:16you know gut cleaning or uh vitamins and
1:06:19this and that are not currently
1:06:22uh approved or effective in myioitis. At
1:06:26least I can tell you that from from my
1:06:28experience um they're currently yeah
1:06:31though those medicine may help you in
1:06:33general lifestyle but will not help you
1:06:35in myioitis per se. will help you. It's
1:06:39up to you. But there's no proof for
1:06:41those things to work.
1:06:43>> Okay.
1:06:44>> In myioitis, there may be proof in other
1:06:46diseases,
1:06:46>> but not because myioid is an autoimmune
1:06:48disease.
1:06:49>> So, we have to calm down the immune
1:06:51system
1:06:52>> for a good part of the immune system,
1:06:54not the bad a bad part of the immune
1:06:56system has to be calmed down while
1:06:58keeping preserving the good part. And
1:07:00that can only be done through a specific
1:07:02targeted medicine because we know what
1:07:05part of the immune system have run gone
1:07:07bad in my dermatomioitis. We have drugs
1:07:10now to target that part part of immune
1:07:12system through clinical trials.
1:07:14>> Okay. And one more question does carti
1:07:17cell therapy work on the myioitis?
1:07:19>> Yes, carti therapies have been a totally
1:07:23different treatment that has remarkable
1:07:25effects in myioitis. However, it's still
1:07:28in clinical trial. I would not want you
1:07:30to do party outside the clinical trial
1:07:32maybe through clinical trial if it's
1:07:34available but they uh some because it is
1:07:36a very uh also has some risk.
1:07:40>> So I would like you to understand the
1:07:41risk and benefit before you go for it.
1:07:45>> Okay. Okay. Sure. Sure.
1:07:47>> Thank you.
1:07:48>> With that
1:07:48>> thank you everyone.
1:07:49>> With that we come to an end of the Q&A
1:07:51round. First of all thank you to all the
1:07:54three speakers Dr. Fani Kumar, Dr.
1:07:56Rohital and Dr.
1:07:57for their patient listening of all the
1:07:59patient queries and we thank all the
1:08:01patient and the attendees for being so
1:08:03forthcoming and confident in asking the
1:08:05questions about the disease they are
1:08:06suffering from and we thank everyone for
1:08:08this comprehensive insight into what
1:08:10clinical triioitis are. So thank you all
1:08:13for attending this meeting and sparing
1:08:15the time and we look forward to seeing
1:08:18you all in the next webinar. Thank you
1:08:20so much.
1:08:21>> Thank you. Thank you. Thank you.

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