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NCT04895878 Clinical Trial

Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome

Sjogren's Syndrome Clinical Trial

Official title:
Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04895878
Other study ID # RECHMPL21_0288
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date September 1, 2021

Study information
Verified date September 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date September 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (3)

Guellec D, Cornec-Le Gall E, Groh M, Hachulla E, Karras A, Charles P, Dunogué B, Abad S, Alvarez F, Gérard F, Devauchelle-Pensec V, Pers JO, Puéchal X, Guillevin L, Saraux A, Cornec D; CRI (Club Rhumatismes et Inflammation) and the French Vasculitis Study — View Citation

Lee SB, Choi H, Kim MK, Jung SM, Song JJ, Park YB, Lee SW. Can antineutrophil cytoplasmic antibody positivity at diagnosis predict the poor outcomes of Sjögren's syndrome? Rheumatol Int. 2020 Jul;40(7):1063-1070. doi: 10.1007/s00296-019-04476-5. Epub 2019 — View Citation

Ramos-Casals M, Brito-Zerón P, Font J. The overlap of Sjögren's syndrome with other systemic autoimmune diseases. Semin Arthritis Rheum. 2007 Feb;36(4):246-55. Epub 2006 Sep 22. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Severity of Sjögren disease Severity of Sjögren disease day 1 (Upon diagnosis)
Secondary Sjögren extra-glandular complications Sjögren extra-glandular complications day 1 (Upon diagnosis)
Secondary severity of ANCA vasculitis severity of ANCA vasculitis day 1 (Upon diagnosis)
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