IgA Vasculitis Clinical Trial
— COLCHIVASOfficial title:
Evaluation of Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis
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.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | May 12, 2023 |
Est. primary completion date | November 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
France | Saint Louis Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02967068 -
VCRC Tissue Repository
|
||
Recruiting |
NCT02593565 -
Vasculitis Pregnancy Registry
|
||
Recruiting |
NCT05329090 -
Evaluation of Glucocorticoids Plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients With Newly-Diagnosed or Relapsing IgA Vasculitis
|
Phase 3 | |
Active, not recruiting |
NCT05168475 -
Biologics in Refractory Vasculitis
|
Phase 2 | |
Recruiting |
NCT03004326 -
Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
|
||
Completed |
NCT03410290 -
Journey of Patients With Vasculitis From First Symptom to Diagnosis
|
||
Recruiting |
NCT02939573 -
A Randomized Multicenter Study for Isolated Skin Vasculitis
|
Phase 2 | |
Recruiting |
NCT05003986 -
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
|
Phase 2 |