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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
IgA Vasculitis

Intervention / Treatment
-----------------
* Drug: Colchicine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: colchicine 1mg/day<br>Colchicine per os: 1 tablet (1mg) / day during 6 months | Drug: Colchicine<br>* colchicine 1mg/day<br>|
| Placebo Comparator: placebo<br>placebo 1 tablet / day during 6 months | Drug: Colchicine<br>* colchicine 1mg/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence of the first cutaneous skin relapse | Cutaneous skin relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia. | 6 months |