At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
Apremilast +1 moredrug
Likely dose
Apremilast 10mgfrom 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.
Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004)in the Treatment of Ankylosing Spondylitis (AS)
In Brief
A Phase 2 clinical trial evaluating Apremilast and Placebo (sugar pill) for Ankylosing Spondylitis. Completed, enrolled 38 participants across 1 site.
Detailed Summary
This study will evaluate the effectiveness of apremilast in AS as measured by improvement in patients' signs and symptoms of the disease and changes in imaging. Additionally the safety and tolerability of apremilast in AS will be assessed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesUnited Kingdom
CollaboratorsCelgene Corporation
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedJul 23, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.9 years ago
Interventions
Apremilastdrug
10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
Placebo (sugar pill)drug
twice a day