Informations générales (source: ClinicalTrials.gov)

NCT04008316 Statut inconnu
Evaluation of Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis (COLCHIVAS)
Interventional
  • Vascularite
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2019
mai 2023
29 juin 2024
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Bichat AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
AP-HP - Hôpital Cochin AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
AP-HP - Hôpital Europeen Georges Pompidou AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
AP-HP - Hôpital Henri Mondor-Albert Chenevier AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
AP-HP - Hôpital La Pitié-Salpêtrière AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
AP-HP - Hôpital Lariboisiere-Fernand Widal AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
AP-HP - Hôpital Saint Antoine AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
AP-HP - Hôpital Tenon AUDEMARD-VERGER Alexandra Complet 18/04/2025 07:56:35  Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Saint Louis Hospital - 75010 - Paris - France Evangeline PILLEBOUT, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

1. Age ≥ 18 years and < 85 years

2. 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


1. 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)

2. 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).

3. Prior (< 3 months) immunosuppressive or corticosteroid therapy

4. Additional cutaneous, and/or digestive and/or chronic renal diseases.

5. HIV and B and C Chronic hepatitis

6. Pregnancy or breast feeding or women without sufficient contraception among women of
childbearing

7. Known allergy or intolerance to study medication or any of its excipients (lactose,
saccharose)

8. Contraindication to colchicine such as:

- severe hepatic insufficiency

- combination with a macrolide (except spiramycin),

- combination with pristinamycin

9. Participation in another interventional trial

10. Patient having not signed an informed consent

11. Patient without Social Security System Insurance