Moderate to Severe Rheumatoid Arthritis (RA)
Conditions
Brief summary
Change from baseline in DAS28-CRP at Week 14
Detailed description
ACR20 response rate at Week 14, ACR50 response rate at Week 14, ACR70 response rate at Week 14, Change from baseline in DAS28-ESR at Week 14, Change from baseline in SDAI score at Week 14, Change from baseline in CDAI score at Week 14, Change from baseline in SF-36 score at Week 14, Incidence and severity of the following: - Adverse events - Serious adverse events - Adverse events leading to study treatment discontinuation - Adverse events of special interest - Change from baseline in selected vital signs - Change from baseline in selected clinical laboratory test results, Serum concentration of RO7790121 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 |
|---|---|
| Change from baseline in DAS28-CRP at Week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20 response rate at Week 14, ACR50 response rate at Week 14, ACR70 response rate at Week 14, Change from baseline in DAS28-ESR at Week 14, Change from baseline in SDAI score at Week 14, Change from baseline in CDAI score at Week 14, Change from baseline in SF-36 score at Week 14, Incidence and severity of the following: - Adverse events - Serious adverse events - Adverse events leading to study treatment discontinuation - Adverse events of special interest - Change from baseline in selected vital signs - Change from baseline in selected clinical laboratory test results, Serum concentration of RO7790121 at specified timepoints | — |
Countries
Belgium, Denmark, France, Germany, Italy, Poland, Spain
Outcome results
None listed