RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)
This study is a Phase 2 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
PD-1 agonist antibody
Placebo
Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints
Time frame: Baseline to Week 12
American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12
Time frame: Baseline to Week 12
American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12
Time frame: Baseline to Week 12
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AnaptysBio Investigative Site 10-132
Flagstaff, Arizona, United States
AnaptysBio Investigative Site 10-130
Glendale, Arizona, United States
AnaptysBio Investigative Site 10-129
Phoenix, Arizona, United States
AnaptysBio Investigative Site 10-131
Tucson, Arizona, United States
AnaptysBio Investigative Site 10-105
Covina, California, United States
Anaptys Bio Investigative Site 10-119
Rancho Mirage, California, United States
AnaptysBio Investigative Site 10-113
San Diego, California, United States
AnaptysBio Investigative Site 10-127
San Francisco, California, United States
AnaptysBio Investigative Site 10-136
Temecula, California, United States
AnaptysBio Investigative Site 10-133
Upland, California, United States
...and 82 more locations