CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
Apremilast 30 mg +1 moredrug
Likely dose
Apremilast 30 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/NCT01925768
NCT01925768Phase 3Completed

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) Monotherapy in Subjects With Active Psoriatic Arthritis

Amgen·interventional·Posted Aug 20, 2013·Updated May 12, 2020

In Brief

A Phase 3 clinical trial evaluating Apremilast 30 mg and Placebo for Psoriatic Arthritis. Completed, enrolled 219 participants across 71 sites in 10 countries.

Detailed Summary

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Czechia, Estonia, Hungary, New Zealand, Romania, Russia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 20, 2013
Enrollment StartSep 4, 2013
Primary CompletionFeb 25, 2015
Study CompletionNov 17, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.9 years ago

Interventions

Apremilast 30 mgdrug

30mg of Apremilast will be orally administered twice daily for 104 weeks

Placebodrug

Identically appearing Placebo tablets will be orally administered twice daily for up to 24 weeks