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A pragmatic, double-blind, randomised, placebo-controlled trial of methotrexate to treat painful knee osteoarthritis

The PROMOTE trial is designed as a pragmatic, randomised, double-blind, placebo-controlled multi-centre clinical trial. Patients will be randomised on a 1:1 basis to the intervention (methotrexate, tapering dose starting at 10mg) or placebo. The duration of treatment in the study will be 12 months from baseline, and the target sample size is 160 participants.The primary outcome will be average overall knee pain severity over the 1-week period prior to measurement, as scored on a 11-point numerical rating numerical rating scale (NRS) at 6 months after the start of treatment. An internal pilot phase is incorporated into the trial to enable variability of the primary outcome measure to be established. An updated sample size calculation will be performed following this pilot phase if necessary.

Participants in the methotrexate arm will take 10 mg methotrexate for 2 weeks, followed by 15 mg for two weeks, 20 mg for 2 weeks and increased to 25 mg for the remainder of the study if no toxicity at physician’s discretion. A similar tapered dose labelling will be established for the placebo arm. Concomitant use of any drug licensed for use in OA will be permitted, except for steroids.This trial will include an MRI imaging substudy at all centres. The purpose of this substudy is to assess levels of synovitis at baseline and at the 6 month primary endpoint to determine whether change in synovitis is related to change in symptoms.

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