Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Summary

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.

Timeline

Start

2013-09-04

Primary completion

2015-02-25

Completion

2016-11-17

Outcome

Met primary endpoint

registry Placebo (PBO) vs Apremilast (APR) 30 mg; p = 0.0040; Adjusted Difference 17.7 (95% CI 6.2 to 29.3) NCT01925768 ↗

Publications

• Background Nash P, Ohson K, Walsh J, Delev N, Nguyen D, Teng L, Gomez-Reino JJ, Aelion JA; ACTIVE investigators. Early and sustained efficacy with apremilast monotherapy in biological-naive patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). Ann Rheum Dis. 2018 May;77(5):690-698. doi: 10.1136/annrheumdis-2017-211568. Epub 2018 Jan 17.
• Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.

Drugs

Indications