Phase 3 Trial of Weekly Subcutaneous Abatacept Versus Placebo in Adults Aged 50 and Older With Giant Cell Arteritis

What this Trial Is About

Researchers are evaluating the effectiveness of abatacept, given by weekly injection, in people aged 50 and older who have been newly diagnosed with or have relapsing Giant Cell Arteritis GCA. This is a Phase 3 randomized, double-blind, placebo-controlled trial aiming to compare abatacept with placebo in achieving remission of GCA. The study is sponsored by the University of Pennsylvania and includes patients with active disease within 8 weeks prior to screening. Participants will be randomly assigned to receive either abatacept 125 mg or a placebo by subcutaneous injection once a week for at least 12 months. Those who reach remission will continue their assigned treatment for 12 months before stopping. If a participant does not achieve remission by 3 months, or experiences a relapse or disease worsening within the first year, they may enter an open-label phase to receive abatacept for up to 12 months. During the study, participants will be monitored regularly to assess remission status, safety, and quality of life using questionnaires like SF-36 and PROMIS. Researchers will measure the proportion of participants in remission at 12 months, duration of glucocorticoid-free remission, and the safety of abatacept. The total involvement may last up to 24 months if the participant enters the open-label extension. Close follow-up will ensure treatment adherence and assess any disease progression or side effects.

Abatacept for the Treatment of Giant Cell Arteritis