Moderate to Severe Rheumatoid Arthritis
Conditions
Brief summary
Mean change from Baseline in DAS28-CRP at Week 12 (Primary Efficacy Endpoint)
Detailed description
ACR20 response rate at Week 12, ACR50 response rate at Week 12, ACR70 response rate at Week 12, Proportion of subjects with DAS28-CRP <3.2 (low disease activity) at Week 12, Proportion of subjects with DAS28-CRP < 2.6 (remission) at Week 12, Proportion of subjects with CDAI <=10 (low disease activity) at Week 12
Interventions
DRUGA sterile
DRUGcolorless to brown-yellow and clear to opalescent solution composed of the same excipients used in the rosnilimab active dp.
DRUGRosnilimab
Sponsors
Anaptysbio Inc., Anaptysbio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from Baseline in DAS28-CRP at Week 12 (Primary Efficacy Endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20 response rate at Week 12, ACR50 response rate at Week 12, ACR70 response rate at Week 12, Proportion of subjects with DAS28-CRP <3.2 (low disease activity) at Week 12, Proportion of subjects with DAS28-CRP < 2.6 (remission) at Week 12, Proportion of subjects with CDAI <=10 (low disease activity) at Week 12 | — |
Countries
Belgium, Estonia, France, Germany, Hungary, Italy, Poland, Slovakia, Spain
Outcome results
None listed