Efficacy of Colchicine to prevent skin relapses in adult's IgA vasculitis

INTERVENTION: Trade Name: COLCHICINE OPOCALCIUM 1 mg, comprimé sécable Pharmaceutical Form: Tablet INN or Proposed INN: Colchicine CAS Number: 64‐86‐8 Current Sponsor code: COLCHICINE OPOCALCIUM Other descriptive name: COLCHICINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Immunoglobulin A vasculitis ; MedDRA version: 20.0 Level: LLT Classification code 10047121 Term: Vasculitis Henoch‐Schonlein like System Organ Class: 100000004858 Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: ; 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; 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. Timepoint(s) of evaluation of this end point: Number of patients who have presented at least one cutaneous relapse 6 months after inclusion INCLUSION CRITERIA: a) Age = 18 years and < 85 years b) 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64 SECONDARY OUTCOME: ; 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