ANCA Associated VasculitisNCT04895878
Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome
An observational study of ANCA Associated Vasculitis and Sjogren's Syndrome, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA Associated Vasculitis, Sjogren's Syndrome
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in internal medicine services in secondary care centers of Languedoc-Roussillon region.
Who may be able to join
- Diagnosis of ANCA vasculitis based on clinical, immunological and histopathological features.
- Diagnosis of Sjögren syndrom based on ACR/EULAR 2016 criteria.
Who cannot join
- Age < 18 years
- Insuffisant data during follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review
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.
- Conditions
- ANCA Associated Vasculitis, Sjogren's Syndrome
- Keywords
- Overlap syndrom
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjogren's Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Sjögren disease
Severity of Sjögren disease
Measured: day 1 (Upon diagnosis)
Secondary outcomes (2)
Sjögren extra-glandular complications
Sjögren extra-glandular complications
Measured: day 1 (Upon diagnosis)
severity of ANCA vasculitis
severity of ANCA vasculitis
Measured: day 1 (Upon diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 May 2021
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ANCA Associated VasculitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe GUILPAIN, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895878
- Sponsor's protocol ID
- RECHMPL21_0288
- Status last verified
- Sep 2021
- First submitted
- 10 May 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
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 25916811Lee 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 31720749Ramos-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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review
- ClinicalTrials.gov ID
- NCT04895878
- Acronym / sponsor ID
- RECHMPL21_0288
- Conditions
- ANCA Associated Vasculitis, Sjogren's Syndrome
- Keywords
- Overlap syndrom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in internal medicine services in secondary care centers of Languedoc-Roussillon region.
Key inclusion criteria (2 listed)
- Diagnosis of ANCA vasculitis based on clinical, immunological and histopathological features.
- Diagnosis of Sjögren syndrom based on ACR/EULAR 2016 criteria.
Key exclusion criteria (2 listed)
- Age < 18 years
- Insuffisant data during follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of Sjögren disease
Time frame: day 1 (Upon diagnosis)
Severity of Sjögren disease
2 secondary outcomes
Sjögren extra-glandular complications
Time frame: day 1 (Upon diagnosis)
severity of ANCA vasculitis
Time frame: day 1 (Upon diagnosis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Results publication: PubMed 25916811Guellec 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.
- Results publication: PubMed 31720749Lee 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.
- Results publication: PubMed 16996579Ramos-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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe GUILPAIN, MD, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANCA Associated Vasculitis and Sjogren's Syndrome, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Sjögren disease (time frame: day 1 (Upon diagnosis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04895878, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.