Hand osteoarthritis MedDRA version: 16.0 Level: LLT Classification code 10019115 Term: Hand osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Plaquenil
Product Name: Hydroxychloroquine
Product Code: n/a
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxychloroquine sulphate
CAS Number: 747-36-4
Concentration unit: mg millig
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients to be included must meet the following criteria: 1. • Patient-reported inadequate response/toxicity to their existing medication (to include paracetamol, oral NSAID or opioid). • Moderately severe symptoms (=4/10 on a 0-10 visual analogue scale) at screening. • Symptoms for more than half of days in the last 3 months. • Fulfil the American College of Rheumatology criteria for OA (see Appendix 2). • Radiograph of the hands in the past 5 years with changes consistent with OA. • No change in the average weekly dose of analgesics (including NSAIDs) for at least 4 weeks. • 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. • Be able to adhere to the study visit schedule and other protocol requirements. • Capable of giving informed consent and the consent must be obtained prior to any screening procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Patients will be excluded from this study for any of the following reasons: 1. • Presence of inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy, Lyme disease) or fibromyalgia • Evidence of psoriasis • 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 months or use of other anti-synovial agents (e.g.slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine) during the last 2 months ?. • Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint. • Planned hand surgery in the next 6 months. • 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. • Pregnant or lactating • Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 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 • Uncontrolled disease states, such as moderate/severe asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids • Melanoma or non-skin 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 o Haemoglobin 2 times ULN for the laboratory conducting the test. o Creatinine > 1.5 times ULN for the laboratory conducting the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary question to be answered by this study is whether hydroxychloroquine is an effective treatment for relieving pain in hand OA. ;Primary end point(s): The primary outcome will be change in average overall hand pain severity in the past 2 weeks scored on a 0-10 numerical rating score at 6 months.;Timepoint(s) of evaluation of this end point: 6 months;Secondary Objective: In addition to this primary question there are several secondary questions we propose to address: (1) How long does it take for the treatment to work and how long will it be effective? (2) Does hydroxychloroquine improve health related quality of life for people with hand OA? (3) Does hydroxychloroquine treatment reduce joint damage as demonstrated using X-rays? (4) Does baseline arthritis-related inflammation predict response to hydroxychloroquine? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Structural assessment at baseline and 12 months Bilateral hand X-ray 2. Self-reported questionnaires at baseline, 3, 6 and 12 months • AUSCAN (pain, stiffness and function)41 – 5 point likert scale • 21-point Numerical Rating Scales (NRS) and VAS scales for • Average overall hand pain severity / pain in the most painful joint over the past 2 weeks / 2 days * • NRS scales for • Global disease activity / average thumb pain / average pain in other joints over the past 2days • Severity rating of participant nominated main functional problem over the past 2 days42 • Satisfaction with hand function over the past 2 days • Hand pain/aching/stiffness over the last month (no days-all days Self-reported questionnaires at baseline, 6 and 12 months • Quality of life using SF12v243 and OAQoL • EuroQol EQ-5D44,45 • HADS Self-report measures at 3, 6 and 12 months • Global* improvement in hand problem • Global* improvement in hand pain • Global* improvement in ability to use hands *A 6-point likert scale: completely better, much better, better, no change, worse, much worse Other measures Baseline measures • Pain elsewhere (pain manikin) • Duration of hand pain over the past 12 months (1 month, 3 months) • Onset of hand pain (last 12 months, 1-5 years, 5-10 years, 10 years or more) • Ultrasound synovitis score Clinical measures (baseline, 6 and 12 months) • Grip strength (JAMAR)46 • Pinch strength (B & L pinch gauge)46 • Functional performance using the Grip Ability Test (GAT)47 • Joint count Adherence to the protocol Self-report measure of adherence will be included at the 6 and 12 month follow-up visits. Adherence will be monitored using the Brief Medication Questionnaire48. In addition, pharmacy will keep a record of all returned medication to provide an estimate of compliance. ;Timepoint(s) of evaluation of this end point: 3, 6, 9 and 12 months, as specified above. | — |
Countries
United Kingdom
Outcome results
None listed