Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome
1 other identifier
observational
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedSeptember 14, 2021
September 1, 2021
3 months
May 10, 2021
September 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of Sjögren disease
Severity of Sjögren disease
day 1 (Upon diagnosis)
Secondary Outcomes (2)
Sjögren extra-glandular complications
day 1 (Upon diagnosis)
severity of ANCA vasculitis
day 1 (Upon diagnosis)
Eligibility Criteria
Patients treated in internal medicine services in secondary care centers of Languedoc-Roussillon region.
You may qualify if:
- Diagnosis of ANCA vasculitis based on clinical, immunological and histopathological features.
- Diagnosis of Sjögren syndrom based on ACR/EULAR 2016 criteria.
You may not qualify if:
- Age \< 18 years
- Insuffisant data during follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34295, France
Related Publications (3)
Guellec D, Cornec-Le Gall E, Groh M, Hachulla E, Karras A, Charles P, Dunogue B, Abad S, Alvarez F, Gerard F, Devauchelle-Pensec V, Pers JO, Puechal X, Guillevin L, Saraux A, Cornec D; CRI (Club Rhumatismes et Inflammation) and the French Vasculitis Study Group. ANCA-associated vasculitis in patients with primary Sjogren's syndrome: detailed analysis of 7 new cases and systematic literature review. Autoimmun Rev. 2015 Aug;14(8):742-50. doi: 10.1016/j.autrev.2015.04.009. Epub 2015 Apr 24.
PMID: 25916811RESULTLee 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 Sjogren's syndrome? Rheumatol Int. 2020 Jul;40(7):1063-1070. doi: 10.1007/s00296-019-04476-5. Epub 2019 Nov 12.
PMID: 31720749RESULTRamos-Casals M, Brito-Zeron P, Font J. The overlap of Sjogren's syndrome with other systemic autoimmune diseases. Semin Arthritis Rheum. 2007 Feb;36(4):246-55. doi: 10.1016/j.semarthrit.2006.08.007. Epub 2006 Sep 22.
PMID: 16996579RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philippe GUILPAIN, MD, PhD
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 20, 2021
Study Start
May 1, 2021
Primary Completion
August 1, 2021
Study Completion
September 1, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09