Does hydroxychloroquine provide effective pain relief for people with hand osteoarthritis?

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 248

Inclusion Criteria

1. Patient-reported inadequate response/toxicity to their existing medication (to include paracetamol, oral NSAID or opioid)
2. Moderately severe symptoms (=4/10 on a 0-10 visual analogue scale) at screening
3. Symptoms for more than half of days in the last 3 months
4. Fulfil the American College of Rheumatology criteria for OA
5. Radiograph of the hands in the past 5 years with changes consistent with OA
6. No change in the average weekly dose of analgesics (including NSAIDs) for at least 4 weeks
7. 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
8. Be able to adhere to the study visit schedule and other protocol requirements
9. Capable of giving informed consent and the consent must be obtained prior to any screening procedures

Exclusion Criteria

Current exclusion criteria as of 25/08/2016:
1. Presence of inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy, Lyme disease) or fibromyalgia
2. Evidence of psoriasis
3. OA of the 1st CMC joint and no symptomatic OA in other hand joints
4. Oral, IM, IA, or IV steroids or other anti-synovial agents during the last 2 months
5. Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint
6. Planned hand surgery in the next 6 months
7.Sensitivity, anaphylaxis or allergy to hydroxychloroquine or any other 4-aminoquinoline compound
8. Unexplained visual impairment that is not corrected by glasses or presence of any eye problems
9. Pregnant or lactating
10. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer
11. 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
12. Uncontrolled disease states, such as moderate/severe asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
13 .Melanoma or non-skin cancer in the past 3 years
14. IA hyaluronans to the hand joints within the last 6/12
15. Intolerance to lactose
16. Significant haematological or biochemical abnormality
16.1. Haemoglobin < 8.5 g/dL
16.2. WCC < 3.5 x 109/L
16.3. Neutrophils < 1.5 x 109/L
16.4. Platelets < 100 x 109/L
16.5. ALT > 2 times ULN for the laboratory conducting the test
16.6. Creatinine > 1.5 times ULN for the laboratory conducting the test

Previous exclusion criteria:
1. Presence of inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy, Lyme disease)
2. Evidence of plaque psoriasis
3. OA of the 1st CMC joint and no symptomatic OA in other hand joints
4. Oral, IM, IA, or IV steroids during the last 2 months
5. Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint
6. Planned hand surgery in the next 6 months
7. Sensitivity, anaphylaxis or allergy to hydroxychloroquine or any other 4-aminoquinoline compound
8. Unexplained visual impairment that is not corrected by glasses or presence of any eye problems
9. Pregnant or lactating
10. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer
11. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average overall hand pain severity over the past 2 weeks (0-10 numerical rating scale) at 6 months.

Secondary Outcome Measures

Name	Time	Method

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