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COLCHIVAS: Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04008316
Collaborator
(none)
264
Enrollment
1
Location
2
Arms
42
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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. It 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 To assess efficacy of colchicine in adult's cutaneous IgA-V, the investigators conduct a prospective, controlled, double blind, randomized clinical trial, national, multicenter and multidisciplinary (internal medicine, nephrology and dermatology): colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up. The primary objective is to evaluate 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis
Actual Study Start Date :
Nov 12, 2019
Anticipated Primary Completion Date :
Nov 12, 2022
Anticipated Study Completion Date :
May 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: colchicine 1mg/day

Colchicine per os: 1 tablet (1mg) / day during 6 months

Drug: Colchicine
colchicine 1mg/day
Placebo Comparator: placebo

placebo 1 tablet / day during 6 months

Drug: Colchicine
colchicine 1mg/day

Outcome Measures

Primary Outcome Measures

  1. the occurrence of the first cutaneous skin relapse [6 months]

    Cutaneous skin relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. 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).

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

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

  3. HIV and B and C Chronic hepatitis

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

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

  6. Contraindication to colchicine such as:

  • severe hepatic insufficiency

  • combination with a macrolide (except spiramycin),

  • combination with pristinamycin

  1. Participation in another interventional trial

  2. Patient having not signed an informed consent

  3. Patient without Social Security System Insurance

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Louis Hospital Paris France 75010

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Evangeline PILLEBOUT, MD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04008316
Other Study ID Numbers:
  • P170910J
  • 2018-002114-13
First Posted:
Jul 5, 2019
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vasculitis
Purpura, Schoenlein-Henoch
Colchicine

Study Results

No Results Posted as of Oct 4, 2021