NCT04108468

GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

An Investigator-initiated Double-blind, Parallel-group Randomised Controlled Trial of GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA Using Clinical and Whole Body MRI Outcomes: the GOLMePsA Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase IIIb. Early Psoriatic Arthritis. Investigator initiated, double-blind, randomized, placebo-controlled, two-armed, parallel-group, single centre trial. The Primary Objective is to assess whether the combination of golimumab with methotrexate and steroids is superior to standard care (MTX monotherapy plus steroids) in reducing clinical disease activity in patients with early, treatment naïve PsA.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate
DRUG	Golimumab	Simponi

Timeline

• Start date: 2015-10-27
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2019-09-30
• Last updated: 2025-12-02
• Results posted: 2025-12-02

Locations

1 site across 1 country: United Kingdom