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CompletedNCT04895878Updated Sep 14, 2021

Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome

An observational study in ANCA Associated Vasculitis and Sjogren's Syndrome, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-14.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
5
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • ANCA Associated Vasculitis
  • Sjogren's Syndrome

Keywords

  • Overlap syndrom
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In context

Sjogren's Syndrome

372 studies on the registry are indexed under Sjogren's Syndrome; 105 are open to participants now.

This study's enrollment of 5 is below the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated in internal medicine services in secondary care centers of Languedoc-Roussillon region.

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

Exclusion criteria:

  • Age \< 18 years
  • Insuffisant data during follow-up
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
5 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Severity of Sjögren disease

    Severity of Sjögren disease

    Time frame: day 1 (Upon diagnosis)

Secondary outcomes

  1. Sjögren extra-glandular complications

    Sjögren extra-glandular complications

    Time frame: day 1 (Upon diagnosis)

  2. severity of ANCA vasculitis

    severity of ANCA vasculitis

    Time frame: day 1 (Upon diagnosis)

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Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
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References and documents

Publications

  • 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. PubMed 25916811 ↗
  • 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 Sjogren's syndrome? Rheumatol Int. 2020 Jul;40(7):1063-1070. doi: 10.1007/s00296-019-04476-5. Epub 2019 Nov 12. PubMed 31720749 ↗
  • Ramos-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. PubMed 16996579 ↗

Individual participant data

Plan to share: Undecided — NC

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04895878
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
May 20, 2021
Start date
May 1, 2021
Primary completion
Aug 1, 2021
Completion
Sep 1, 2021
Last update
Sep 14, 2021

Study contacts

Philippe GUILPAIN, MD, PhD
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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