Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Giant Cell Arteritis
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- STATUS
- Recruiting
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- participants needed
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Summary
The main purpose of this study is to understand how well giant cell arteritis (also known as temporal arteritis; GCA) responds to an investigational drug called sarilumab. Sarilumab needs to be tested to find out if it is safe and effective in treating GCA. An investigational drug is one that is not approved by the United States Food and Drug Administration. Patients with new onset GCA or those with disease relapse may be eligible to take part. Participants will be assigned at random to receive either sarilumab plus prednisone or a placebo plus prednisone. A placebo is a harmless inactive substance. The study drug/placebo is injected under the skin. Participation will last about 1 year and 8 months. There are about 14 study visits at Penn.
FAQ
Details
| Condition | giant cell arteritis,GCA,vasculitis,temporal arteritis |
|---|---|
| Age | 18years - 87years |
| Clinical Study Identifier | 03600805 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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