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

  • STATUS
    Recruiting
  • participants needed
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Updated on 19 February 2024

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 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.

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Condition giant cell arteritis,GCA,temporal arteritis,vasculitis
Age 50years - 100years
Clinical Study IdentifierNCT03725202
Last Modified on19 February 2024

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