CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 490 enrolled
Drug / intervention
Apremilast tablet 20 mg +2 moredrug
Likely dose
Apremilast tablet 20 mgfrom 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.

Search/NCT01583374
NCT01583374Phase 3Completed
CompareCT.gov

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS

Amgen·interventional·Posted Apr 24, 2012·Updated May 12, 2020

In Brief

A Phase 3 clinical trial evaluating Apremilast tablet 20 mg, Apremilast tablet 30 mg BID, and 1 other intervention for Ankylosing Spondyloarthritis. Completed, enrolled 490 participants across 103 sites in 18 countries.

Detailed Summary

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondyloarthritis
CountriesAustralia, Austria, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Netherlands, Poland, Romania, Russia, Slovakia, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2012
Enrollment StartMay 2, 2012
Primary CompletionFeb 24, 2014
Study CompletionOct 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.2 years ago

Interventions

Apremilast tablet 20 mgdrug

Apremilast 20 mg was taken orally twice a day (BID)

Apremilast tablet 30 mg BIDdrug

Apremilast 30 mg was taken orally twice a day

Placebodrug

Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.