NCT04601883已完成4 期
Colchicine Treatment for Patients With Hand Osteoarthritis: A Randomised, Placebo-controlled Trial.
Henning Bliddal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Finger pain
研究概览
简要总结
The study aims to compare oral colchicine 0.5 mg administered two times daily for 12 weeks with placebo as a treatment of hand OA symptoms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Hand OA according to the ACR criteria above.
- •Hand OA finger pain: Pain at rest ≥40 mm on VAS (0 to 100 mm range).
排除标准
- •Comorbidities
- •Other known medical disease that may affect joints, e.g. RA, gout, PsA
- •Positive anti-cyclic citrullinated peptide (>10 kU/L)
- •Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
- •Known blood dyscrasias and coagulation disorders
- •Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
- •Elevated alanine transaminase (>45 U/L females, >70 U/L for males)
- •Creatinine clearance ≤60 ml/min
- •Elevated creatine kinase (>210 U/L females, >280 U/L for males)
- •Known allergies towards the interventions
- •Drug or alcohol abuse in the last year
- •Generalised pain syndromes such as fibromyalgia
- •Current reflux
- •Current or recurrent diarrhoeal illnesses
- •Current abdominal pain
- •Known peripheral neuropathies
- •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.
- •Medical history
- •History of hand surgery within 12 months prior enrolment.
- •History of arthroplasty or arthrodesis in the hand Management strategies
- •Treatment with P-glycoprotein inhibitors and/or cytochrome P450 3A4 (CYP3A4) inhibitors, see section "Colchicine safety in drug-drug interactions" and table
- •If potential participants have been treated with these pharmaceuticals previously, treatment must be terminated 5 half-lifes before initiation of study drug.
- •Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months.
- •Participation in experimental device or experimental drug study 3 months prior to enrolment.
- •Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
- •Intra-articular corticosteroids into any joint 1 months before inclusion
- •Current use of synthetic or non-synthetic opioids
- •Scheduled surgery during study participation
- •Planning to start other treatment for hand OA in the study participation period.
- •Reproductive system
- •Planned pregnancy within the study period, 3 months after end of study treatment for female fertile participant and 6 months after end of study treatment for male participant.
- •Insufficient anti-conception therapy for female fertile participants within the study period and 3 months after end of study treatment. Sufficient anti-conception therapy consists of intra-uterine device (coil),hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections) or sexual abstinence Female participants are considered infertile if they are postmenopausal or if they have undergone surgical sterilisation (bilateral salpingectomy, hysterectomy or bilateral oophorectomy). Postmenopausal state is defined as no menses for 12 months without alternative medical cause before inclusion in the study. Menopause state will be confirmed by measurement of follicle stimulating hormone.
- •Insufficient anti-conception therapy for male participants within the study period and 6 months after end of study treatment. Sufficient anti-conception therapy consists of condom or sexual abstinence. Male participants are considered sterile if they have undergone surgical sterilisation (vasectomy).
- •Breast-feeding
- •A target hand will be selected for outcome assessment once individual fulfills in- and exclusions criterias. Selection of the target hand will adhere to the following, with advancement to next step if unable to choose target hand based on the given criteria.
- •The hand with most overall pain, assessed by VAS finger joint pain.
- •The hand with most overall reduced function, assessed by AUSCAN function subscale.
- •The hand with most overall stiffness, assessed by AUSCAN stiffness subscale.
- •The hand with most swollen joints, assessed by physician joint count.
- •The hand with most tender joints, assessed by physician joint count.
- •The hand with highest summed radiographic score, assessed by radiographic scoring of conventional X-ray.
- •If unable to select target hand based on the above criteria, a target hand will be randomly assigned.
研究组 & 干预措施
Colchicine
Experimental
Tablet colchicine 0.5 mg administered two times daily
干预措施: Colchicine 0.5 MG (Drug)
Placebo
Placebo Comparator
Tablet placebo administered two times daily
干预措施: Placebo (Drug)
结局指标
主要结局
Finger pain
时间窗: Week 12
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, on changes in finger joint pain of the target hand from baseline to week 12, in patients with painful hand OA measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms.
次要结局
- Function(Week 12)
- Thumb base pain(Week 12)
- Pain hands(Week 12)
- Joint activity(Week 12)
- Patient global assessment(Week 12)
- Quality of life measured by European Quality of Life 5 Dimensions(Week 12)
- Hand strength(Week 12)
- Number of treatment responders according to OMERACT-OARSI response criteria(Week 12)
研究者
Henning Bliddal
MD, DMSci, Professor of Rheumatology
Frederiksberg University Hospital
研究点 (1)
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