Clinical Trial

Abatacept for the Treatment of Giant Cell Arteritis

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2020-07-16; most recent amendment 2026-01-21.
Status change: Active, Not Recruiting → Recruiting 2024-08-19
Status change: Recruiting → Active, Not Recruiting 2022-10-12
Status change: Not Yet Recruiting → Recruiting 2021-03-16
Trial Details
NCT Number NCT04474847
Lead Sponsor University of Pennsylvania
Conditions Giant Cell Arteritis
Enrollment 78 participants
Start Date 2021-03-29
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-23