Does anyone know about this clinical study ... interested?
I think these are newer studies.
https://www.novartis.com/clinicaltrials/study/nct05767034
and
https://www.novartis.com/clinicaltrials/study/nct04930094
Interested in more discussions like this? Go to the Polymyalgia Rheumatica (PMR) Support Group.
They appear to be the same study, first one for PMR and the second one for GCA. I guess it depends on if you fit the criteria for the study and if you live close enough to one of the locations listed for your country in the study.
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)
Iowa City is recruiting ... I'm surprised Mayo isn't.
My rheumatologist mentioned to me that Cosentyx, a monoclonal antibody to interleukin-17A might be an option for me down the road if Actemra stops working.
I'm just pleased that treatment options other than prednisone are being looked at for PMR/GCA. It is about time ... I think.
All I know is these inflammation pathways get complicated very quickly when my rheumatologist gets going.
Upstream and downstream effects of cytokines are way over my head. There aren't single inflammation pathways. It is more like a network of pathways with a lot of cross talk.
Remember that you could be on the no treatment
placebo cohort. Would they provide the active drug
for you after the study is completed?
That is usually how it works in regards to getting the active drug if the study results are favorable. It is like a thank-you for participating in the study kind of thing. Not all drug companies will do this and it takes a long time to analyze all the data.
A "Double-blind, Placebo-controlled study" means neither you or your doctor will know if you are getting the study drug or not. You won't be randomized to "no treatment."
The current standard of care is prednisone alone. You will still get prednisone. The purpose of these studies is to see if people have a good response to the study medication compared with getting prednisone alone.
Another endpoint is to see if a sustained remission can be achieved faster while on the study drug and prednisone. The hope is people can get off prednisone sooner and not need prednisone for a long time. Doctors are well aware of what is called the "steroid burden" which refers to the long term side effects from prednisone.