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

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2018-002114-13-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 264

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

Exclusion Criteria

a)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/creatiniuria> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified