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Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04895878
Collaborator
(none)
5
Enrollment
1
Location
4
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ANCA vasculitis and Sjögren syndrome are two rare diseases, and even more rarely associated. These two conditions have specific organ involvements, and specific follow-up.

The Investigators hypothesise that patients with co-occurrence of these two diseases may have a singular clinical course.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review
    Actual Study Start Date :
    May 1, 2021
    Actual Primary Completion Date :
    Aug 1, 2021
    Actual Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Severity of Sjögren disease [day 1 (Upon diagnosis)]

      Severity of Sjögren disease

    Secondary Outcome Measures

    1. Sjögren extra-glandular complications [day 1 (Upon diagnosis)]

      Sjögren extra-glandular complications

    2. severity of ANCA vasculitis [day 1 (Upon diagnosis)]

      severity of ANCA vasculitis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Diagnosis of ANCA vasculitis based on clinical, immunological and histopathological features.

    • Diagnosis of Sjögren syndrom based on ACR/EULAR 2016 criteria.

    Exclusion criteria:

    • Age < 18 years

    • Insuffisant data during follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Philippe GUILPAIN, MD, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04895878
    Other Study ID Numbers:
    • RECHMPL21_0288
    First Posted:
    May 20, 2021
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 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
    Keywords provided by University Hospital, Montpellier
    Overlap syndrom
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Vasculitis
    Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
    Syndrome

    Study Results

    No Results Posted as of Sep 14, 2021