At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 480 enrolled

Drug / intervention

Placebo +1 moredrug

Likely dose

Golimumab 2mg/kgfrom 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/NCT02181673

NCT02181673Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis

Janssen Research & Development, LLC·interventional·Posted Jul 4, 2014·Updated Dec 21, 2017

In Brief

A Phase 3 clinical trial evaluating Placebo and Golimumab for Arthritis, Psoriatic. Completed, enrolled 480 participants across 88 sites in 12 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsArthritis, Psoriatic

CountriesAustralia, Belarus, Canada, Germany, Hungary, Lithuania, Poland, Romania, Russia, Spain, Ukraine, United States

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

First PostedJul 2014

Enrollment StartSep 2014

Primary CompletionMay 2016

Study CompletionMar 2017

TodayJul 2026

First PostedJul 4, 2014

Enrollment StartSep 8, 2014

Primary CompletionMay 5, 2016

Study CompletionMar 22, 2017

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 12.0 years ago

Interventions

Placebodrug

Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.

Golimumabdrug

Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.