EUCTR2011-004300-38-GB进行中（未招募）1 期
HERO:Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA, a randomised, double-blind, placebo-controlled trial - HERO:Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA
niversity of Leeds0 个研究点目标入组 252 人开始时间: 2012年5月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
研究者
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