Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) : a Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Change from baseline in patient's assessment of arthritis pain on a visual analogue scale
研究概览
简要总结
Hand osteoarthritis is one of the most common arthritis, resulting in pain in finger and thumb base joints. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. Currently limited therapy options are available. Synovial inflammation is involved in the joint pain. Iguratimod is a small disease-modifying compound that can influence anti-inflammatory pathways in models of rheumatoid arthritis. It has an anabolic effect on the bone metabolism of infected joint by osteoclastogenesis inhibition and osteoblast differentiation. The investigators hypothesize that Iguratimod will alleviate pain of patient with inflammatory hand osteoarthritis, and that a beneficial effect of Iguratimod on pain will be accompanied by a decrease of synovial inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Other known medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, Lyme disease, Systemic lupus erythematosus, Sjogren Syndrome, Systemic sclerosis.
- •involving carpometacarpal [CMC] joints, without interphalangeal joints.
- •Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint disorders of the elbow or shoulder, poly-articular chondrocalcinosis, fibromyalgia).
- •Trigger finger, injury in joints within past 6 months.
- •Slow-acting drugs for OA (e.g. glucosamine, chondroitin, diacerhein) initiated within the previous 3 months before the study.
- •Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before screening.
- •Intra-articular corticosteroids into any joint or use of systemic corticosteroids 1 month before screening.
- •Treatment with analgesics initiated within the previous 1 month and NSAIDs initiated within the previous 2 weeks.
- •History of hand surgery within 12 months prior enrolment.
- •Participation in experimental device or experimental drug study 3 months prior to enrolment.
- •Scheduled surgery during study participation.
- •Pregnant or lactating women，planned pregnancy within the study period, 3 months after end of study treatment for female fertile participant.
- •Known blood dyscrasias and coagulation disorders.
- •Elevated alanine transaminase (AST/ALT > 2x upper normal range).
- •GRF (MDRD) < 60 mg/min/1.73m
- •Known viral hepatitis B or C.
- •Uncontrolled diseases, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
- •History of peptic ulcer.
- •Patients who have severe comorbidities, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, GI disease. Known any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.
研究组 & 干预措施
Iguratimod group
subjects with Iguratimod
干预措施: Iguratimod (Drug)
placebo group
subjects with placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in patient's assessment of arthritis pain on a visual analogue scale
时间窗: 12 weeks
Change from baseline in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 12 weeks of treatment; higher value indicate worse outcome.
次要结局
- Change from baseline in Ultrasound record(12 weeks)
- Change from baseline in OMERACT hand OA magnetic resonance imaging score(12 weeks)
- Change from baseline in the Scores of SF-36 questionnaire(12 weeks)
- Change from baseline in patient's assessment of arthritis pain on a visual analogue scale prior to each visit(4 weeks, 8 weeks, 12 weeks)
- Change from baseline in Functional Index for Hand Osteoarthritis (FIHOA)(12 weeks)
- Change from baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) scores at each visit.(4 weeks, 8 weeks, 12 weeks)
- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ)(12 weeks)
- Change from baseline in Michigan Hand Outcomes Questionnaire (MHOQ)(12 weeks)