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

Phase 1

• Conditions: Hand osteoarthritis; MedDRA version: 16.0Level: LLTClassification code 10019115Term: Hand osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-004300-38-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-10
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 252

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

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
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•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
oHaemoglobin<8.5 g/dL
oWCC<3.5 x 109/L
oNeutrophils<1.5 x 109/L
oPlatelets<100 x 109/L
oALT> 2 times ULN for the laboratory conducting the test.
oCreatinine> 1.5 times ULN for the laboratory conducting the test

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified