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

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ClinicalTrials.gov Identifier: NCT04008316
Recruitment Status : Not yet recruiting
First Posted : July 5, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
IgA Vasculitis Drug: Colchicine 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : November 18, 2019
Estimated Primary Completion Date : November 18, 2022
Estimated Study Completion Date : May 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis
Drug Information available for: Colchicine

Arms and Interventions
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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
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Primary Outcome Measures :
  1. the occurrence of the first cutaneous skin relapse [ Time Frame: 6 months ]
    Cutaneous skin relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008316


Contacts
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Contact: Evangeline PILLEBOUT, MD +33 1 42 49 96 05 evangeline.pillebout@aphp.fr
Contact: Alexandra AUDMARD-VERGER, MD +33 2 31 06 45 79 alexandra.audemard-verger@chu-caen.fr

Locations
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France
Saint Louis Hospital
Paris, France, 75010
Contact: Evangeline PILLEBOUT, MD    +33 1 42 49 96 053    evangeline.pillebout@aphp.fr   
Contact: Alexandra AUDMARD-VERGER, MD    +33 2 31 06 45 79    alexandra.audemard-verger@chu-caen.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Evangeline PILLEBOUT, MD APHP
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04008316    
Other Study ID Numbers: P170910J
2018-002114-13 ( EudraCT Number )
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vasculitis
Vascular Diseases
Cardiovascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents