A Study of Guselkumab in Participants With Active Psoriatic Arthritis

NCT04882098 ↗

Phase 3 Active not recruiting 1054 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The 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.

Timeline

Start: 2021-06-17
Primary completion: 2024-12-30
Completion: 2027-10-06

Outcome

Met primary endpoint

registry Group 1: Guselkumab 100 mg q8w vs Group 3: Placebo Followed by Guselkumab; p <0.001; Difference in percentage 21.3 (95% CI 14.4 to 28.2) NCT04882098 ↗

registry Group 2: Guselkumab 100 mg q4w vs Group 3: Placebo Followed by Guselkumab; p <0.001; Difference in percentage 19.7 (95% CI 12.1 to 27.2) NCT04882098 ↗

release “TREMFYA®(guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20a) of reducing signs and symptoms” jnj.com ↗

Publications

Ritchlin CT, Coates LC, Mease PJ, van der Heijde D, Song J, Jiang Y, Shawi M, Kollmeier AP, Rahman P. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2023 Jan 10;24(1):22. doi: 10.1186/s13063-022-06945-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Guselkumab	Monoclonal antibody	—	Subcutaneous