CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 615 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Ustekinumab 45 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/NCT01009086
NCT01009086Phase 3Completed

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Aanti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis

Janssen Research & Development, LLC·interventional·Posted Nov 6, 2009·Updated Mar 3, 2015

In Brief

A Phase 3 clinical trial evaluating Placebo, Ustekinumab 45 mg, and 1 other intervention for Arthritis, Psoriatic. Completed, enrolled 615 participants across 102 sites in 14 countries.

Detailed Summary

The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Canada, Finland, Germany, Hungary, Latvia, Lithuania, New Zealand, Poland, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2009
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2011
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.7 years ago

Interventions

Placebodrug

SC injections

Ustekinumab 45 mgdrug

SC injections

Ustekinumab 90 mgdrug

SC injections