Abatacept for the Treatment of Giant Cell Arteritis
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 p
| Condition(s) | Giant Cell Arteritis |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. A diagnosis of newly diagnosed or relapsing GCA. Diagnostic criteria for GCA A patient will be said to have GCA by meeting 3 of 5 of the following modified ACR criteria for the classification of GCA in which 1 of the 3 must consist of criteria 4 or 5: 1. Age at disease onset ≥ 50 years. 2. New onset or new type of localized pain in the head. 3. ESR of \> 40 mm in the first hour by the Westergren method or CRP measurement above the laboratory normal limit. 4. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries). 5. Temporal artery or large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usual |
| Ages | 50 Years |
| Sex | All |
| Lead sponsor | University of Pennsylvania |
| Locations | Rochester, Minnesota, United States; New York, New York, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Vancouver, British Columbia, Canada (+3 more sites) |
| Start date | 2021-03-29 |
| NCT ID | NCT04474847 |
| Official listing | https://clinicaltrials.gov/study/NCT04474847 |