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DiscussionDoes anyone know about this clinical study ... interested?
Polymyalgia Rheumatica (PMR) | Last Active: Mar 3 11:52am | Replies (4)Comment receiving replies
Replies to "Remember that you could be on the no treatment placebo cohort. Would they provide the active..."
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.