GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

Phase 3 Completed 84 enrolled The Leeds Teaching Hospitals NHS Trust Janssen Pharmaceutica N.V., Belgium · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

An investigator-initiated double-blind, parallel-group randomised controlled trial of Methotrexate versus GOLimumab and Methotrexate in very early PsA using clinical and whole body MRI outcomes.

Timeline

Start: 2015-10-27
Primary completion: 2023-07
Completion: 2023-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Methotrexate vs Golimumab & Methotrexate; p = 0.064; Mean Difference (Final Values) -0.55 (95% CI -1.12 to 0.03); Regression, Linear NCT04108468 ↗

Publications

De Marco G, Maksymowych WP, Ostergaard M, Eshed I, Tan AL, Helliwell PS, McGonagle D, Hensor EMA, Marzo-Ortega H. Whole body-MRI identifies widespread, low intensity inflammation in peripheral joints, and axial involvement in a third of patients with early, treatment-naive, active PsA: data from the GOLMePsA clinical trial. Rheumatology (Oxford). 2026 Jun 30;65(7):keag308. doi: 10.1093/rheumatology/keag308.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Golimumab	Monoclonal antibody	—	—
Background	Methotrexate	Small molecule	—	—