CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 383 enrolled
Drug / intervention
Guselkumab +1 moredrug
Likely dose
Guselkumab 100mgfrom 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/NCT03162796
NCT03162796Phase 3Completed

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNF Alpha Agents

Janssen Research & Development, LLC·interventional·Posted May 22, 2017·Updated Feb 3, 2021

In Brief

A Phase 3 clinical trial evaluating Guselkumab and Placebo for Arthritis, Psoriatic. Completed, enrolled 383 participants across 95 sites in 13 countries.

Detailed Summary

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Czechia, Germany, Hungary, Malaysia, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 22, 2017
Enrollment StartAug 24, 2017
Primary CompletionMar 14, 2019
Study CompletionNov 18, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.1 years ago

Interventions

Guselkumabdrug

Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.

Placebodrug

Participants will receive matching placebo as SC injection.