ISRCTN91859104已完成未知
Hydroxychloroquine Effectiveness in Reducing symptoms of hand Osteoarthritis: a randomised, double-blind, placebo-controlled trial
niversity of Leeds (UK)0 个研究点目标入组 248 人开始时间: 2012年10月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 248
研究概览
简要总结
2013 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/23452375 protocol 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29459986 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34950454/ Cost-effectiveness (added 24/01/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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