CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 312 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/NCT01077362
NCT01077362Phase 3Completed

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)

Janssen Research & Development, LLC·interventional·Posted Mar 1, 2010·Updated Feb 27, 2014

In Brief

A Phase 3 clinical trial evaluating placebo, ustekinumab 45 mg, and 1 other intervention for Arthritis, Psoriatic. Completed, enrolled 312 participants across 80 sites in 10 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, France, Germany, Hungary, Poland, Russia, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2010
Enrollment StartMar 1, 2010
Primary CompletionMar 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.3 years ago

Interventions

placebodrug

SC injections

ustekinumab 45 mgdrug

SC injections

ustekinumab 90 mgdrug

SC injections