Giant Cell Arteritis
Conditions
Brief summary
The primary study endpoint will be the proportion of individuals in remission at Month 12 of those randomized to abatacept as compared to placebo.
Detailed description
Safety (adverse events/serious adverse events/SUSARs) in patients with GCA taking abatacept compared with placebo, Patient reported outcomes (Mean change from Baseline/Month 0 over time to Month 12 in SF-36, PROMIS) in patients with GCA taking abatacept compared with placebo, Median duration of glucocorticoid-free remission from Month 6 to Month 12 in patients with GCA taking abatacept compared with placebo
Interventions
DRUGAbatacept
DRUGplacebo for abatacept injection
DRUG125 mg/syringe
Sponsors
Trustees Of The University Of Pennsylvania
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint will be the proportion of individuals in remission at Month 12 of those randomized to abatacept as compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (adverse events/serious adverse events/SUSARs) in patients with GCA taking abatacept compared with placebo, Patient reported outcomes (Mean change from Baseline/Month 0 over time to Month 12 in SF-36, PROMIS) in patients with GCA taking abatacept compared with placebo, Median duration of glucocorticoid-free remission from Month 6 to Month 12 in patients with GCA taking abatacept compared with placebo | — |
Countries
Germany, Italy
Outcome results
None listed