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 |