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

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    264
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 10 October 2021

Summary

Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schnlein 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 Behet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude.

Description

Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schnlein 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 Behet 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.

Details
Condition IgA Vasculitis
Treatment colchicine
Clinical Study IdentifierNCT04008316
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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