Immunoglobulin A vasculitis MedDRA version: 20.0 Level: LLT Classification code 10047121 Term: Vasculitis Henoch-Schonlein like System Organ Class: 100000004858
Conditions
Interventions
Trade Name: COLCHICINE OPOCALCIUM 1 mg, comprimé sécable
Pharmaceutical Form: Tablet
INN or Proposed INN: Colchicine
CAS Number: 64-86-8
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: a) Severe renal IgA vasculitis: - impaired renal function, defined as an eGFR 1g/l - Uncontrolled blood pressure (Systolic blood pressure > 170 mmHg, diastolic blood pressure > 100 mmHg) b) Severe digestive IgA vasculitis: - intussusception - massive gastrointestinal haemorrhage - intestinal ischemia - perforation - abdominal pain persisting more than one day (EVA > 5) and unresponsive to standard analgesics (level 1 or 2). c) Prior (< 3 months) immunosuppressive or corticosteroid therapy d) Additional cutaneous, and/or digestive and/or chronic renal diseases. e) HIV and B and C Chronic hepatitis f) Pregnancy or breast feeding or women without sufficient contraception among women of childbearing g) Known allergy or intolerance to study medication or any of its excipients (lactose, saccharose) h) Contraindication to colchicine such as: - severe hepatic insufficiency - combination with a macrolide (except spyramicin), - combination with pristinamycin i) Participation in another interventional trial j) Patient having not signed an informed consent k) Patient without Social Security System Insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of 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.;Primary end point(s): Number of patients who have presented at least one cutaneous relapse in the colchicine group versus the placebo group, 6 months after inclusion. Cutaneous relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.; Secondary Objective: 1/ To assess efficacy of colchicine vs. placebo at M6 in: - Preventing cutaneous relapses - Preventing extra-cutaneous (articular and/or digestive and/or kidney) new involvements or relapses 2/ To assess a remanent effect of colchicine vs. placebo at M12 in: - Preventing cutaneous relapses - Preventing extra-cutaneous (articular and/or digestive and/or kidney) new involvements or relapses 3/ To assess efficacy of colchicine vs. placebo in preventing relapses consequence 4/ To assess colchicine safety (adverse events) and compliance ;Timepoint(s) of evaluation of this end point: Number of patients who have presented at least one cutaneous relapse 6 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time (in days) to first cutaneous relapse - Number of cutaneous relapses per patients at M6 and M12 - Rate of patients who have presented at least a severe cutaneous relapse at M0, M6 and M12 - 36-item Short-form Health Survey (SF-36) score at M6 and M12 - Rate of patients displaying at least one work stoppage related to IgAV between M0 and M12 and number of days of work stoppage per patient. - Rate of patient who consulted in emergency for IgA relapse or new organ involvement between M0 and M12. - Adverse events associated with Colchicine and compliance at M3 and M6 - Clinical, biological and histological candidate predictors at diagnosis. ;Timepoint(s) of evaluation of this end point: idem | — |
Countries
France
Contacts
Public ContactDRCI Hôpital Saint Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (APHP)
Outcome results
None listed