NCT01200472

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

A Phase 2, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel-group,Efficacy Study of Apremilast (CC-10004)in Subjects With Erosive Hand Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erosive Osteoarthritis of the Hand

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast is supplied as 10 mg capsules for oral administration. After a 7-day titration phase patients will receive 20 mg PO BID apremilast.
DRUG	Placebo	Placebo capsules identical to apremilast

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2010-09-13
• Last updated: 2013-10-21

Locations

3 sites across 1 country: Germany