Efficacy Study of Apremilast (CC-10004) in Subjects With Erosive Hand Osteoarthritis

Summary

STUDY DESIGN: This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in 30 patients with erosive osteoarthritis of interphalangeal joints. The study is composed of 4 phases: a pre-randomization phase for up to 35 days followed by a 91-day randomized, double-blind two arm treatment phase, followed by a 77-day open label treatment phase for all study participants and a 28-day observational follow-up phase. Efficacy of the double blind and open label phase will be assessed at study day 84 and 168 after treatment start respectively. STUDY DURATION: The study length will be approximately 231 days for individual patients. With approximately a 12 month recruitment period the study is planned to last from January 2010 until July 2011 (19 months). STUDY OBJECTIVES: The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day \[BID\], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the symptoms of erosive hand osteoarthritis. Further objectives are to evaluate the effects on pain, disease activity, structural damage, quality of life, safety and tolerability.

Timeline

Start

2010-08

Primary completion

2013-08

Completion

2013-10

Drugs

Indications