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Polymyalgia Rheumatica (PMR) - Clinical Trials
Are people aware there is this trial recruiting (still?) Centerwatch--dot-com
...safety-and-efficacy-of-abbv-154-in-subjects-with-polymyalgia-rheumatica-pmr-dependent-on-glucocorticoid-treatment
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Thank-you for sharing this information.
The study appears to be still active but no longer recruiting.
https://clinicaltrials.gov/ct2/show/NCT04972968I think this happens sometimes because preliminary data isn't promising. I don't know anything about this experimental medication.
It doesn't seem promising because apparently "AbbVie is shutting down development of Humira-steroid antibody-drug congugate (Abbv154) after interim analysis. Very disappointing news for our hopes of novel combo strategies."
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2 Reactions@johnbishop maybe title of this thread should be changed to "trials" in general - 2023 Are people interested to see these ? thank you
IF you are being treated at Yale - you be aware of Monique Hinchcliff, MD, MS-- there is an observation trial collecting blood from patients w/ PMR.
Another approach is anti IL-17 -- this trial has a US site in Spokane -
Secukinumab is a novel biologic agent specifically targeting interleukin-17 (IL-17) involved in a pathological process. It is a fully human monoclonal antibody.
ICH GCP
US Clinical Trials Registry
Clinical Trial NCT05767034
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) (REPLENISH)
April 12, 2023 updated by: Novartis Pharmaceuticals
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
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2 Reactions@nyxygirl - We changed the discussion title to hopefully bring more members together who are interested in what clinical trials are available for PMR. Here is a list of some that I found available on CenterWatch.com:
--- Polymyalgia Rheumatica (PMR) Clinical Trials: https://www.centerwatch.com/clinical-trials/listings/condition/733/polymyalgia-rheumatica-pmr/
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4 ReactionsIt is sad there aren't more treatment options for PMR/GCA. I was told many times that prednisone was the "only option" or the "best option." I took prednisone for more than 12 years for PMR. I asked many times if there was "any other options." The side effects of prednisone were taking a toll on me so I was willing to try anything else.
My rheumatologist had to get authorization to try Actemra (tocilizumab). An exception was made for me because Actemra isn't FDA approved for PMR but it is for GCA. My rheumatologist thought Actemra should work for PMR but didn't know if it would or not.
Actemra worked for me and I was able to taper off prednisone in a year. My rheumatologist thinks I'm better off on Actemra and I would agree.
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4 Reactions@dadcue your story is amazing ! Are you aware that there is June 8 deadline for "patient perspective " for the upcoming ACR meeting ? rheumatology-dot- org. annual-meeting-patient-perspectives
What Is Eligible for Submission?
Submissions should meet one of the following criteria:
Address the question: “What adaptations did you and/or your healthcare team adopt to better care for your health?"
Describe how you became more engaged in healthcare.
Demonstrate an idea that was put into practice, and how the idea resulted in improved quality of life.
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3 ReactionsThank-you but when I looked to find information I found the following:
"What Is Not Eligible for Submission?
Medication- or therapy-specific interventions will not be accepted."
The most significant thing that improved my quality of life was getting off prednisone. For 12 years, my life revolved around how much prednisone to take daily for PMR. My doctors helped me and encouraged me to keep trying to taper off prednisone yet they prescribed more prednisone than I needed. They didn't want me to ever run out. I'm grateful for the prednisone I received.
Actemra (tocilizumab) is an IL-6 receptor blocker that allowed me to get off prednisone. IL-6 is implicated in other autoimmune disorders so not just PMR/GCA. Now Kevzara is another IL-6 receptor blocker that was recently FDA approved for PMR.
I didn't think I would ever be able to get off prednisone. I tell my rheumatologist that taking prednisone was easy to do except for the long term side effects. Getting off prednisone was hard to do. I just wish that Actemra had been tried sooner because it made tapering off prednisone much easier. Actemra wasn't an option for me. Actemra was only FDA approved for GCA in 2017. I don't have GCA.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-specifically-treat-giant-cell-arteritisIt was my rheumatologist who thought Actemra should work for PMR and was willing to submit the authorization request to get it approved for me.
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4 ReactionsBy the way .... Intravenous administration of Actemra wasn't approved for giant cell arteritis (GCA) in 2017. Getting medications approved for use takes time.
On February 28, 2022, the FDA approved Genentech's intravenous (IV) formulation of Actemra (tocilizumab), for treatment of giant cell arteritis (GCA) in adult patients.
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1 Reaction@dadcue yes - i see your how you are interpreting the submission guidelines/requirements - " recently diagnosed patients like myself may not have anything to offer yet ! Here are the details :
What Is Eligible for Submission? Submissions should meet one of the following criteria:
Address the question: “What adaptations did you and/or your healthcare team adopt to better care for your health?"
Describe how you became more engaged in healthcare.
Demonstrate an idea that was put into practice, and how the idea resulted in improved quality of life.
What Is Not Eligible for Submission?
Medication- or therapy-specific interventions will not be accepted.
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1 ReactionDec2023 --
Clinical Study ID
NCT05767034
CAIN457C22301
2022-501895-25-00. @cliffg26 there is a study site in Spokane ! https://www.centerwatch.com/clinical-trials/listings/NCT05767034/phase-iii-study-of-efficacy-and-safety-of-secukinumab-versus-placebo-in-combination-with-glucocorticoid-taper-regimen-in-patients-with-polymyalgia-rheumatica-pmr?lat=42.35866&long=-71.05674&q=Polymyalgia%20Rheumatica%20Pmr&location=Boston,%20MA,%20United%20States&sortBy=distance
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4 ReactionsHI all - I was searching around and also found another trial that seems to be recruiting -by Sparrow Tx.
Whoa - talk about knowing how to target an audience !! https://sparrowpharma.com/contact. but sadly the study centers seem to be in Germany ! : ( Perhaps a little more digging by west coast PMR patients into Sparrow can reveal additional subject matter experts ?
>>" There’s a better way to address the ravages of glucocorticoid excess. " Get in touch to learn about our new therapies. to learn more about PROST!, our ongoing clinical trial of SPI-47 for patients with PMR, including how to inquire about participation
https://www.centerwatch.com/clinical-trials/listings/NCT05436652/a-trial-of-prednisolone-in-combination-with-spi-62-or-placebo-in-subjects-with-polymyalgia-rheumatica-pmr?id=733&slug=polymyalgia-rheumatica-pmr.
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2 Reactions