A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis

Phase 1

• Conditions: active psoriatic arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-005214-19-NL
• Lead Sponsor: Academic Medical Center, Department of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-20
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Psoriatic arthritis according to the CASPAR classification
- Active disease, minimally 3 swollen and tender joints
- 18-70 years
- a stable dose of concomitant NSAIDs and/or corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent = 10 mg/day and must be stable for at least 4 weeks prior to baseline.
- Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and electrocardiography (ECG).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Methotrexate naive
TNF blocker naive
Concurrent DMARD use
Malignancy <5 years ago
no active children wish, pregnancy or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in methotrexaat naïve PsA patients<br> ;<br> Primary end point(s): - Safety<br> - DAS remission<br> ;Timepoint(s) of evaluation of this end point: week 22;<br> Secondary Objective: - to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in MTX naïve PsA patients<br> - to demonstrate that initial treatment of MTX naïve patients with golimumab + MTX is superior to MTX alone to maintain low to very low disease activity over time after withdrawing golimumab treatment<br>