Hand osteoarthritis Musculoskeletal Diseases Other arthrosis
Conditions
Interventions
Patients will be randomised in a 1:1 ratio to one of two groups:
Hydroxychloroquine used in combination with drugs licensed for use in pain management of OA
with choice of drugs and doses determined by clinicians for individual participants.
Placebo group used in combination with drugs licensed for use in pain management of OA
with choice of drugs and doses determined by clinicians for individual participants.
Dosage will be as follows:
1. Participants with an ideal body weight of 30 - 45 kg
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average overall hand pain severity over the past 2 weeks (0-10 numerical rating scale) at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Structural assessment at baseline and 12 months: Bilateral hand X-ray Self-reported questionnaires at baseline, 3, 6 and 12 months: 1. AUSCAN (pain, stiffness and function)? 5-point likert scale 2. 11-point Numerical Rating Scales (NRS) and VAS scales for 3. Average overall hand pain severity/pain in the most painful joint over the past 2 weeks/2 days* 4. NRS scales for 5. Global disease activity/average thumb pain/average pain in other joints over the past 2 days 6. Satisfaction with hand function over the past 2 days 7. Hand pain/aching/stiffness over the last month (no days-all days) Self-reported questionnaires at baseline, 6 and 12 months: 1. Quality of life using SF12v2 and OAQoL 2. EuroQol EQ-5D 3. HADS Self-report measures at 3, 6 and 12 months: 1. Global* improvement in hand problem 2. Global* improvement in hand pain 3. Global* improvement in ability to use hands *A 6-point likert scale: completely better, much better, better, no change, worse, much worse Baseline measures: 1. Pain elsewhere (pain manikin) 2. Duration of hand pain over the past 12 months (1 month, 3 months) 3. Onset of hand pain (last 12 months, 1-5 years, 5-10 years, 10 years or more) 4. Ultrasound synovitis score Clinical measures (baseline, 6 and 12 months): 1. Grip strength (JAMAR) 2. Joint count Removed as of 05/09/2016: Severity rating of participant nominated main functional problem over the past 2 days | — |
Countries
England, United Kingdom
Outcome results
None listed