Rheumatoid Arthritis
Conditions
Brief summary
The primary endpoint of the study will be the delta CDAI at 16 weeks
Detailed description
Percentage of patients with DAS28<3.2 (LDA) at 16 weeks., Percentage of patients deemed responders using American College of Rheumatology 50 (ACR50) measure at 16 weeks., Percentage of patients with CDAI remission at 16 weeks, Change in HAQ-DI at 16 weeks from baseline., Change in SF-36 at 16 weeks from baseline
Interventions
DRUGThe placebo for abatacept injection for SC administration is a sterile solution product that compositionally
matches the active product except for the absence of abatacept. It will be identical in dose and administration 125mg/syringe.
Sponsors
Queen Mary University Of London
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study will be the delta CDAI at 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with DAS28<3.2 (LDA) at 16 weeks., Percentage of patients deemed responders using American College of Rheumatology 50 (ACR50) measure at 16 weeks., Percentage of patients with CDAI remission at 16 weeks, Change in HAQ-DI at 16 weeks from baseline., Change in SF-36 at 16 weeks from baseline | — |
Countries
Belgium, Italy, Netherlands, Portugal, Spain
Outcome results
None listed