A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)

Prior treatment

• Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator

Other illness

• History of an inflammatory joint disease other than Rheumatoid Arthritis
• History of cancer within the last 5 years (except for some skin cancers)
• Any known or suspected condition that would compromise immune status

Other

• Pregnant or breastfeeding women

• Aged 18 years or older
• A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial
• Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial
• Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment