NCT04008316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 12, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

October 4, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

July 2, 2019

Last Update Submit

October 1, 2021

Conditions

IgA Vasculitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

colchicine 1mg/day

EXPERIMENTAL

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

Drug: Colchicine

placebo

PLACEBO COMPARATOR

placebo 1 tablet / day during 6 months

Drug: Colchicine

Interventions

ColchicineDRUG

colchicine 1mg/day

colchicine 1mg/dayplacebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis Hospital

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

IgA Vasculitis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmune Complex DiseasesHypersensitivityImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Evangeline PILLEBOUT, MD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evangeline PILLEBOUT, MD

CONTACT

+33 1 42 49 96 05evangeline.pillebout@aphp.fr

Alexandra AUDMARD-VERGER, MD

CONTACT

+33 2 31 06 45 79alexandra.audemard-verger@chu-caen.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

November 12, 2019

Primary Completion

November 12, 2022

Study Completion

May 12, 2023

Last Updated

October 4, 2021

Record last verified: 2021-10

Locations

FR(1)