Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

Phase 4 Completed 210 enrolled Amgen

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).

Timeline

Start: 2011-03
Primary completion: 2013-02
Completion: 2013-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Etanercept; p = 0.055; Odds Ratio (OR) 1.83 (95% CI 0.99 to 3.41); Mantel Haenszel NCT01313208 ↗

Publications

Background Hobbs K, Deodhar A, Wang B, Bitman B, Nussbaum J, Chung J, Collier DH. Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy. Springerplus. 2015 Mar 5;4:113. doi: 10.1186/s40064-015-0895-9. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous
Background	Hydroxychloroquine	Small molecule	—	—
Background	Leflunomide	Small molecule	—	—
Background	Methotrexate	Small molecule	—	—
Background	Minocycline	Small molecule	—	—
Background	Sulfasalazine	Small molecule	—	—