METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis

INTERVENTION: methotrexate ‐ the dose administered: 10 mg weekly for four weeks, followed by 20 mg weekly for the remainder of the study if there is no toxicity as determined at the physician’s discretion (Australian Rheumatology Association Guidelines) ‐ the duration of administration: 2 years ‐ the mode of administration: oral tablet All participants will be prescribed oral folic acid at a minimum dose of 5 mg/week, 6 days/week Pill count will be performed at 4 weeks, 3, 6, 12, 18, and 24 months after randomisation to monitor adherence. CONDITION: Hand osteoarthritis with synovitis PRIMARY OUTCOME: Proportion of participants with radiographic progression of hand osteoarthritis assessed using hand x‐ray Reduction in knee pain score assessed using a 100mm Visual Analogue Scale SECONDARY OUTCOME: Grip strength assessed using hand dynamometer Joint activity assessed using tender and swollen joint count Physical function assessed using Functional Index for Hand Osteoarthritis ; ; ; Progression of bone marrow lesions assessed using magnetic resonance imaging of hand Progression of synovitis assessed using magnetic resonance imaging of hand Quality of life assessed using Short Form‐36 INCLUSION CRITERIA: 1. Aged 40 ‐ 70 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