A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients with Moderate to Severe Rheumatoid Arthritis who have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors

Condition studied

Moderate to Severe Rheumatoid Arthritis (RA)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from baseline in DAS28-CRP at Week 14

Endpoint detail

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