Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis (COLCHIVAS)
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ClinicalTrials.gov Identifier: NCT04008316 |
Recruitment Status :
Recruiting
First Posted : July 5, 2019
Last Update Posted : October 4, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
IgA Vasculitis | Drug: Colchicine | Phase 3 |
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 |
Actual Study Start Date : | November 12, 2019 |
Estimated Primary Completion Date : | November 12, 2022 |
Estimated Study Completion Date : | May 12, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: colchicine 1mg/day
Colchicine per os: 1 tablet (1mg) / day during 6 months
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Drug: Colchicine
colchicine 1mg/day |
Placebo Comparator: placebo
placebo 1 tablet / day during 6 months
|
Drug: Colchicine
colchicine 1mg/day |
- 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.

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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 |
Inclusion Criteria:
- Age ≥ 18 years and < 85 years
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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)
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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)
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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

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
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 |
France | |
Saint Louis Hospital | Recruiting |
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 | |
Principal Investigator: Alexandra AUDMARD-VERGER, MD |
Principal Investigator: | Evangeline PILLEBOUT, MD | APHP |
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: | October 4, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vasculitis Purpura, Schoenlein-Henoch Pathologic Processes Vascular Diseases Cardiovascular Diseases Purpura Blood Coagulation Disorders Hematologic Diseases Hemostatic Disorders Hemorrhagic Disorders Immune Complex Diseases Hypersensitivity |
Immune System Diseases Hemorrhage Skin Manifestations Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |