At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 488 enrolled
Drug / intervention
Apremilast 20mg +3 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
In Brief
A Phase 3 clinical trial evaluating Apremilast 20mg, Apremilast 30mg, and 2 other interventions for Psoriatic Arthritis. Completed, enrolled 488 participants across 98 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. 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
CountriesBelgium, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Italy, Poland, Russia, South Africa, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedOct 2010
Primary CompletionJul 2012
Study CompletionJan 2017
TodayJul 2026
First PostedOct 1, 2010
Enrollment StartSep 27, 2010
Primary CompletionJul 26, 2012
Study CompletionJan 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.8 years ago
Interventions
Apremilast 20mgdrug
Apremilast 20 mg twice daily, orally
Apremilast 30mgdrug
Apremilast 30 mg twice daily, orally
Placebo + 20 mg Apremilastdrug
Placebo + 20 mg Apremilast
Placebo + 30 mg Apremilastdrug
Placebo + 30 mg Apremilast