At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 505 enrolled
Drug / intervention
Apremilast 20mg +2 moredrug
Likely dose
Apremilast 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion
In Brief
A Phase 3 clinical trial evaluating Apremilast 20mg, Apremilast 30mg, and 1 other intervention for Psoriatic Arthritis. Completed, enrolled 505 participants across 91 sites in 16 countries.
Detailed Summary
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis
CountriesAustralia, Canada, Finland, France, Germany, Italy, Lithuania, Poland, Romania, Russia, Slovakia, South Korea, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedOct 2010
Primary CompletionAug 2012
Study CompletionFeb 2017
TodayJul 2026
First PostedOct 1, 2010
Enrollment StartSep 30, 2010
Primary CompletionAug 21, 2012
Study CompletionFeb 9, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.8 years ago
Interventions
Apremilast 20mgdrug
Apremilast 20 mg twice daily, orally
Apremilast 30mgdrug
Apremilast 30 mg twice daily, orally
Placebodrug