METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritiswith Synovitis

Phase 3

Active, not recruiting

• Conditions: Hand osteoarthritis with synovitis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12617000877381
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-15
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Aged 40 - 75 years with symptomatic radiological hand osteoarthritis and synovitis
2. A pain score of greater than or equal to 40mm on a 100mm visual analogue scale and radiological osteoarthritis (Kellgren and Lawrence grade greater than or equal to 2) in at least one joint
3. Evidence of synovitis determined from magnetic resonance imaging with a grade greater than or equal to 1 in at least one joint

Exclusion Criteria

1. Concomitant rheumatic disease, inflammatory joint disease, psoriatic arthritis, ankylosing spondylitis, or gout
2. Contraindication to methotrexate (e.g. renal, liver or haematological condition, cancer including skin cancer, serious infections requiring hospitalisation in the last 5 years, known or past infection with HIV, Hepatitis B or C, Tuberculosis, or known lung disease with scarring (any fibrosis or evidence of past tuberculosis exposure on chest x-ray), concurrent regular prednisolone use, taking regular Trimethoprim or Bactrim antibiotics, egg or flu vaccination allergy, women who are pregnant, breast-feeding or trying to become pregnant, or men who father a child)
3. Contraindication to magnetic resonance imaging (e.g. implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, or claustrophobia)
4. Unable to complete informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified