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

Primary Purpose

IgA Vasculitis

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Colchicine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Vasculitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Louis HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

colchicine 1mg/day

placebo

Arm Description

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

placebo 1 tablet / day during 6 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
October 1, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04008316
Brief Title
Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis
Acronym
COLCHIVAS
Official Title
Evaluation of Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
November 12, 2022 (Anticipated)
Study Completion Date
May 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Vasculitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
colchicine 1mg/day
Arm Type
Experimental
Arm Description
Colchicine per os: 1 tablet (1mg) / day during 6 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo 1 tablet / day during 6 months
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
colchicine 1mg/day
Primary Outcome Measure Information:
Title
the occurrence of the first cutaneous skin relapse
Description
Cutaneous skin relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years and < 85 years 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: 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) 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). Prior (< 3 months) immunosuppressive or corticosteroid therapy Additional cutaneous, and/or digestive and/or chronic renal diseases. HIV and B and C Chronic hepatitis Pregnancy or breast feeding or women without sufficient contraception among women of childbearing Known allergy or intolerance to study medication or any of its excipients (lactose, saccharose) Contraindication to colchicine such as: severe hepatic insufficiency combination with a macrolide (except spiramycin), combination with pristinamycin Participation in another interventional trial Patient having not signed an informed consent Patient without Social Security System Insurance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evangeline PILLEBOUT, MD
Phone
+33 1 42 49 96 05
Email
evangeline.pillebout@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra AUDMARD-VERGER, MD
Phone
+33 2 31 06 45 79
Email
alexandra.audemard-verger@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangeline PILLEBOUT, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evangeline PILLEBOUT, MD
Phone
+33 1 42 49 96 053
Email
evangeline.pillebout@aphp.fr
First Name & Middle Initial & Last Name & Degree
Alexandra AUDMARD-VERGER, MD
Phone
+33 2 31 06 45 79
Email
alexandra.audemard-verger@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Alexandra AUDMARD-VERGER, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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