Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Giant Cell Arteritis

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Giant Cell Arteritis
Recruiting
18 years - 87 years
All
Phase 3
5 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: giant cell arteritis,GCA,vasculitis,temporal arteritis
  • Age: 18 years - 87 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 833160

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