Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis

Phase 2 Terminated 237 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.

Timeline

Start: 2010-12-09
Primary completion: 2012-02-21
Completion: 2012-09-10

Outcome

Missed primary endpoint

Stopped: “Study is terminated due to lack of efficacy”

registry analysis (unspecified test); Placebo vs Apremilast 20 mg; p = 0.3134; Risk Difference (RD) -7.4 (95% CI -27.1 to 7.0); Chi-squared NCT01285310 ↗

registry analysis (unspecified test); Placebo vs Apremilast 30 mg; p = 0.8721; Risk Difference (RD) -1.2 (95% CI -16.2 to 13.8); Chi-squared NCT01285310 ↗

paper CONCLUSION: Apremilast efficacy was not demonstrated in patients who had active RA despite stable MTX therapy. PMID 25779750 ↗

Publications

Genovese MC, Jarosova K, Cieslak D, Alper J, Kivitz A, Hough DR, Maes P, Pineda L, Chen M, Zaidi F. Apremilast in Patients With Active Rheumatoid Arthritis: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study. Arthritis Rheumatol. 2015 Jul;67(7):1703-10. doi: 10.1002/art.39120.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	20 mg	Oral
Subject	Apremilast	Small molecule	30 mg	Oral