The main aim of the Hydroxychloroquine Effectiveness in Reducing symptoms of hand Osteoarthritis (HERO
) trial is to determine the effectiveness of hydroxychloroquine as a treatment for hand osteoarthritis (OA
). It is a multi-centre, double-blind, placebo-controlled pragmatic trial. Participants will be randomised 1:1 to either the treatment group (hydroxychloroquine 200-400mg daily) or the placebo group, and will take study medication for 12 months. The target sample size is 252 participants, and the primary outcome is average overall hand pain severity over the past 2 weeks (0-10 numerical rating scale) at 6 months.
Participants will be allowed to remain on any medications they are taking for their hand OA prior to enrolment (including NSAIDs
, paracetamol, opioids, chondroitin, glucosamine). A single steroid injection to non-hand joints will be allowed after the primary outcome at 6 months. No oral corticosteroids will be allowed for the duration of the trial. There is an ultrasound substudy tagged on to the main trial. For this, baseline ultrasound imaging will be performed for the dominant hand of all patients enrolled at the 7 centres participating in the substudy (Leeds, Kings College London, Nottingham, Keele, Newcastle and Oxford). The sub-study's aim is to determine whether baseline synovitis is a predictor of therapeutic response.