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临床试验/NCT04008316
NCT04008316Unknown3 期

Evaluation of Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2019年11月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
264
试验地点
1
主要终点
the occurrence of the first cutaneous skin relapse

研究概览

简要总结

Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Quality of life can be significantly altered by frequent cutaneous relapses. Colchicine, historically used for gout flares, is known to be an " old " low cost drug inducing very few adverse events. This molecule inhibits polymorphonuclear cell-chemotaxis to the site of inflammation explaining colchicine clinical efficacy in diseases such as Familial Mediterranean Fever or Behçet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude.

详细描述

Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Quality of life can be significantly altered by frequent cutaneous relapses. Colchicine, historically used for gout flares, is known to be an " old " low cost drug inducing very few adverse events. It inhibits polymorphonuclear cell-chemotaxis to the site of inflammation explaining colchicine clinical efficacy in diseases such as Familial Mediterranean Fever or Behçet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude To assess efficacy of colchicine in adult's cutaneous IgA-V, the investigators conduct a prospective, controlled, double blind, randomized clinical trial, national, multicenter and multidisciplinary (internal medicine, nephrology and dermatology): colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up. The primary objective is to evaluate efficacy of colchicine versus placebo to prevent cutaneous relapses, 6 months after inclusion, in adult patients with cutaneous IgA vasculitis alone or associated with non-severe digestive or renal involvement.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years and < 85 years
  • IgA-V recently diagnosed (< 20 days since skin biopsy) and defined by :
  • Histologically proven small vessels vasculitis with IgA deposits IgA Vasculitis
  • Purpura and/or involvement of at least one organ among kidney, joint, or intestinal tract

排除标准

  • Severe renal IgA vasculitis:
  • impaired renal function, defined as an eGFR < 60 ml per minute per 1.73 m2 (MDRD or CKD-EPI formula)
  • proteinuria/creatinuria> 1g/g
  • Uncontrolled blood pressure (Systolic blood pressure > 170 mmHg, diastolic blood pressure > 100 mmHg)
  • Severe digestive IgA vasculitis:
  • intussusception
  • massive gastrointestinal haemorrhage (requiring transfusion)
  • intestinal ischemia
  • perforation
  • abdominal pain persisting more than one day (EVA > 5) and unresponsive to standard analgesics (level 1 or 2).
  • Prior (< 3 months) immunosuppressive or corticosteroid therapy
  • Additional cutaneous, and/or digestive and/or chronic renal diseases.
  • HIV and B and C Chronic hepatitis
  • Pregnancy or breast feeding or women without sufficient contraception among women of childbearing
  • Known allergy or intolerance to study medication or any of its excipients (lactose, saccharose)
  • Contraindication to colchicine such as:
  • severe hepatic insufficiency
  • combination with a macrolide (except spiramycin),
  • combination with pristinamycin
  • Participation in another interventional trial
  • Patient having not signed an informed consent
  • Patient without Social Security System Insurance

研究组 & 干预措施

colchicine 1mg/day

Experimental

Colchicine per os: 1 tablet (1mg) / day during 6 months

干预措施: Colchicine (Drug)

placebo

Placebo Comparator

placebo 1 tablet / day during 6 months

干预措施: Colchicine (Drug)

结局指标

主要结局

the occurrence of the first cutaneous skin relapse

时间窗: 6 months

Cutaneous skin relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Efficacy of Colchicine to Prevent Skin Relapses in... | 临床试验