Rheumatoid Arthritis
Conditions
Brief summary
The primary endpoint of the study will be a binary outcome of treatment responder/nonresponder classified using American College of Rheumatology 50 (ACR-50) measure at 12 weeks.
Detailed description
Percentage of patients with DAS28(ESR)<3.2 (LDA) at 12 weeks, Percentage of patients with CDAI ≤10 (LDA) at 12 weeks, Percentage of patients with CDAI remission at 12 weeks, Change in HAQ-DI at 12 weeks from baseline, Change in SF-36 at 12 weeks from baseline
Interventions
DRUGKevzara 200 mg solution for injection in pre-filled pen
DRUGKevzara 150 mg solution for injection in pre-filled pen
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 a binary outcome of treatment responder/nonresponder classified using American College of Rheumatology 50 (ACR-50) measure at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with DAS28(ESR)<3.2 (LDA) at 12 weeks, Percentage of patients with CDAI ≤10 (LDA) at 12 weeks, Percentage of patients with CDAI remission at 12 weeks, Change in HAQ-DI at 12 weeks from baseline, Change in SF-36 at 12 weeks from baseline | — |
Countries
Belgium, Italy, Netherlands, Portugal, Spain
Outcome results
None listed