Efficacy Study of Apremilast (CC-10004) in Subjects With Erosive Hand Osteoarthritis
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
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.