Study to Evaluate the Safety and Efficacy of Upadacitinib in Giant Cell Arteritis: SELECT-GCA

Study to Evaluate the Safety and Efficacy of Upadacitinib in Giant Cell Arteritis: SELECT-GCA
Recruiting
50 years - 100 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 upadacitinib. Upadacitinib is being 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 (FDA). Patients with a new GCA diagnosis or those with disease relapse may be eligible to take part. Participants will be assigned at random to receive either upadacitinib plus prednisone or a placebo plus prednisone. A placebo is a harmless inactive substance.
Prednisone will be tapered for either 26 or 52 weeks. 
 
The study drug/placebo is taken by mouth.  The first part of the study (Period 1) takes about 1 year and involves 13 visits to Penn.  The second part of the study (Period 2) last about 1 year and includes 7 visits to Penn.

Eligibility of study

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

  • Conditions: giant cell arteritis,GCA,temporal arteritis,vasculitis
  • Age: 50 years - 100 years
  • Gender: All


Updated on 19 Feb 2024. Study ID: 834353

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