GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

Sponsor
The Leeds Teaching Hospitals NHS Trust
Study ID
NCT04108468
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Methotrexate
  • Golimumab — DRUG
    Simponi

Study Details

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.

Key Dates

Start date
Oct 27, 2015
Status verified
Nov 2025
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Methotrexate
  • Experimental: Golimumab & Methotrexate

Primary Outcome Measure

Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks [ Time Frame: 24 weeks ]

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