At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 285 enrolled
Drug / intervention
Guselkumab 100 mg +1 moredrug
Likely dose
Guselkumab 100 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.
Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy
In Brief
A Phase 3 clinical trial evaluating Guselkumab 100 mg and Placebo for Arthritis, Psoriatic. Completed, enrolled 285 participants across 117 sites in 14 countries.
Detailed Summary
The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Psoriatic
CountriesBelgium, Bulgaria, France, Germany, Greece, Hungary, Israel, Italy, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartMar 2019
Primary CompletionNov 2020
TodayJul 2026
First PostedJan 8, 2019
Enrollment StartMar 22, 2019
Primary CompletionNov 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.5 years ago
Interventions
Guselkumab 100 mgdrug
Participants will receive guselkumab 100mg as SC injection.
Placebodrug
Participants will receive placebo as SC injection.