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Table 3 Eligibility criteria

From: Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial

Inclusion criteria Exclusion criteria
Patient-reported inadequate response or toxicity to existing medication (to include paracetamol, oral NSAID or opioid)* Presence of inflammatory arthritis (for example, gout, reactive arthritis, RA, psoriatic arthritis, seronegative spondylarthropathy, Lyme disease)
Evidence of plaque psoriasis
Moderately severe symptoms (≥4/10 on a 0 to 10 VAS) at screening
Symptoms for more than half of days in the last 3 months OA of the 1st CMC joint and no symptomatic OA in other hand joints
Oral, IM, IA or IV steroids during the last 2 months*
Fulfil the American College of Rheumatology criteria for OA Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint*
Radiograph of the hands in the past 5 years with changes consistent with OA Planned hand surgery in the next 6 months
No change in the average weekly dose of analgesics (including NSAIDs) for at least 4 weeks* Sensitivity, anaphylaxis or allergy to hydroxychloroquine or any other 4-aminoquinoline compound
Unexplained visual impairment that is not corrected by glasses or presence of any eye problems
Has used chondroitin or glucosamine for at least 4 months with no change to the average weekly dose, is not using or is willing to stop using if recently started* Pregnant or lactating
Use of any investigational (unlicensed) drug within 1 month prior to screening or within five half-lives of the investigational agent, whichever is longer*
Evidence of serious uncontrolled concomitant medical condition, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, GI disease or epilepsy, which in the opinion of the investigator makes them unsuitable for the study
Be able to adhere to the study visit schedule and other protocol requirements
Capable of giving informed consent, which must be obtained prior to any screening procedures Uncontrolled disease states, such as moderate or severe asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
Melanoma or nonskin cancer in the past 3 years*
IA hyaluronans to the hand joints within the last 6/12*
Intolerance to lactose
Significant haematological or biochemical abnormality
Haemoglobin ≤ 8.5 g/dl
White cell count ≤ 3.5 × 109/l
Neutrophils ≤ 1.5 × 109/l
Platelets ≤ 100 × 109/l
ALT >2 times ULN for the laboratory conducting the test
  Creatinine >1.5 times ULN for the laboratory conducting the test
  1. *Criteria for which participants may be rescreened if they are ineligible at the initial screening visit. CMC, carpometacarpal; IA, intra-articular; IM, intramuscular; IV, intravenous; RA, rheumatoid arthritis; ULN, upper limit of normal; VAS, visual analogue scale.