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

NCT01200472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-10-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Georg Schett, MD · University Hospital Erlangen, Department of Internal Medicine 3, Rheumatology and Clinical Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-08-31
Completion
2013-10-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01200472 on ClinicalTrials.gov