A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BGB-45035 Versus Placebo in Patients With Moderate to Severe Active Rheumatoid Arthritis

Official Summary

This study aims to evaluate the efficacy of BGB-45035 in adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying antirheumatic drugs (bDMARDs)/targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 90 participants

Interventions

• DRUG: BGB-45035 — Administered orally
• DRUG: Placebo — Administered orally

Primary Outcomes

• Change from baseline in Disease Activity Score - C-reactive protein (DAS28-CRP) at Week 12 (Baseline and Week 12)

Secondary Outcomes

• Percentage of participants with a 20% improvement in American College of Rheumatology Criteria (ACR20) (Baseline and Week 12)
• Percentage of participants with a 50% improvement in American College of Rheumatology Criteria (ACR50) (Baseline and Week 12)
• Percentage of participants with a 70% improvement in American College of Rheumatology Criteria (ACR70) (Baseline and Week 12)
• Change from Baseline in Tender Joint Count 68 (TJC 68) (Baseline up to Week 12)
• Change from baseline in Swollen Joint Count 66 (SJC 66) (Baseline up to Week 12)

Trial Locations

• The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China
• Anhui Provincial Hospital, Hefei, Anhui, China
• Peking University First Hospital, Beijing, Beijing Municipality, China
• Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China
• The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
• Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North), Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat Sen University, Guangzhou, Guangdong, China
• Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
• The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
• ...and 10 more locations

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