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

Conditions

• Erosive Osteoarthritis of the Hand

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Sep 13, 2010

Start date

Aug 31, 2010

Status verified

Oct 2013

Primary completion

Aug 31, 2013

Completion

Oct 31, 2013

Study Design

Enrollment

30 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast capsules
  Apremilast in 10 mg capsules
• Placebo Comparator: Placebo

Primary Outcome Measure

Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline [ Time Frame: Day 84 after treatment start compared with baseline ]