Share on facebook Share on Twitter Share on Google Plus Share This
Back to Results

The GSK Giant Cell Arteritis Study


Title 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
Therapeutic Area Giant Cell Arteritis
Principal Investigator Steven C. Vlad, MD, PhD
Min Age 50 Years
Gender All
Contact Vivian Deng
617 636-5727
More Information https://clinicaltrials.gov/ct2/show/NCT02531633

Overview

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.

Study Details

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Requirements

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.