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The GSK Giant Cell Arteritis Study
||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis
Giant Cell Arteritis
||Steven C. Vlad, MD, PhD
GlaxoSmithKline is evaluating a study drug called sirukumab for patients with Giant Cell Arteritis. Sirukumab may help block the activity of interleukin-6 (IL-6), which is involved in changes in the immune system related to GCA. The purpose of this study is to test how well sirukumab keeps GCA from returning once prednisone has been stopped. Sirukumab is given with a tapered prednisone regimen. Participants may also enroll in secondary studies evaluating the genetics and biomarkers associated with GCA.
- Subject must have active GCA within the past 6 weeks.
- Subject must be willing to receive blinded prednisone regimen for the treatment of active GCA.
- Subjects who are pregnant or breastfeeding.
- Subjects with any other autoimmune disease, such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, or other similar systemic connective tissue diseases.
- Subjects who have active infections, or history of recurrent infections, or have required management of acute or chronic infections.
The GSK study will require a total of 25-26 visits over a period of 3 years. Participants will be randomized into 5 treatment groups to receive an injection of sirukumab or placebo every 2 weeks. At the beginning of the study a blinded prednisone taper will start for all treatment groups. 3 out of 5 groups will receive sirukumab and 2 groups will receive placebo. The initial visit to the site will require a chest X-Ray along with blood and urine tests; all subsequent visits will include blood and urine work.