moderate to severe rheumatoid arthritis (RA)
Conditions
Brief summary
Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest
Detailed description
Proportion of participants with American College of Rheumatology ACR20, ACR50, and ACR70 response (improvements will be assessed using the baseline of the parent study), Change from baseline DAS28-CRP), Proportion of participants achieving LDA, CR based on DAS28-CRP, DAS28-ESR, CDAI, or SDAI, Change from baseline in selected clinical laboratory test results, Change from baseline in selected vital signs, Serum concentration of afimkibart at specified timepoints
Interventions
DRUGRO7790121
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with American College of Rheumatology ACR20, ACR50, and ACR70 response (improvements will be assessed using the baseline of the parent study), Change from baseline DAS28-CRP), Proportion of participants achieving LDA, CR based on DAS28-CRP, DAS28-ESR, CDAI, or SDAI, Change from baseline in selected clinical laboratory test results, Change from baseline in selected vital signs, Serum concentration of afimkibart at specified timepoints | — |
Outcome results
None listed