Study to Evaluate the Safety and Efficacy of Upadacitinib in Giant Cell Arteritis: SELECT-GCA
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: Between 50 Years - 100 Years
-
Gender: All
Updated on
11 Jul 2023.
Study ID: 834353
