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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002114-13 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colchicine 1mg/day | Experimental | Colchicine per os: 1 tablet (1mg) / day during 6 months |
|
| placebo | Placebo Comparator | placebo 1 tablet / day during 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | colchicine 1mg/day |
|
| 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 |
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Inclusion Criteria:
Age ≥ 18 years and < 85 years
IgA-V recently diagnosed (< 20 days since skin biopsy) and defined by :
Exclusion Criteria:
Severe renal IgA vasculitis:
Severe digestive IgA vasculitis:
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:
Participation in another interventional trial
Patient having not signed an informed consent
Patient without Social Security System Insurance
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evangeline PILLEBOUT, MD | Contact | +33 1 42 49 96 05 | evangeline.pillebout@aphp.fr | |
| Alexandra AUDMARD-VERGER, MD | Contact | +33 2 31 06 45 79 | alexandra.audemard-verger@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Evangeline PILLEBOUT, MD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis Hospital | Recruiting | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D011695 | IgA Vasculitis |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011693 | Purpura |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.
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| D001778 |
| Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020141 | Hemostatic Disorders |
| D006474 | Hemorrhagic Disorders |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007105 | Immune Complex Diseases |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |