AMG 162 Phase III study (DESIRABLE study)

Phase 3

Completed

• Conditions: rheumatoid arthritis

• Registration Number: JPRN-jRCT2080222228
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

When AMG 162 60 mg was subcutaneously administrated every 6 months or 3 months for 12 months to rheumatoid arthritis patients on DMARDs, both regimens demonstrated significant inhibitory effects, compared with placebo, on the progression of joint destruction, with the change in TSS being smaller for Q3M than for Q6M. Both AMG 162 regimens demonstrated a safety profile similar to that of placebo, indicating that AMG 162 Q6M and Q3M were well tolerated.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-19
• Study Completion: 2017-09-19
• Results First Posted: 2019-04-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 667

Inclusion Criteria

Diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 ACR-EULAR (The European League Against Rheumatism) classification criteria for rheumatoid arthritis

Exclusion Criteria

Functional class IV according by the ACR revised classification (1991)

Study & Design

• Study Type: Interventional
• Study Design: Not specified