PASS: Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT05312944
Collaborator
(none)
15
1
24
0.6

Study Details

Study Description

Brief Summary

To determine the phenotype of patients having PMR symptoms and primary Sjogren syndrome (pSS), we used a French national call to identify patients combining both diseases and collected retrospective clinical and biological data.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A national call to identify patients combining pSS and PMR was disseminated in France. Patients with Sjögren's syndrome associated with rheumatoid arthritis were excluded. We described the global population having both diseases and compared them to two historic prospective cohorts of isolated pSS (the prospective cohort of primary Sjögren DiapSS), or isolated PMR (TENOR, a cohort of recent PMR), regarding clinical, imaging and treatments characteristics.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome : A French Multicentric Retrospective Study (PASS)
    Actual Study Start Date :
    Mar 2, 2021
    Anticipated Primary Completion Date :
    Mar 2, 2023
    Anticipated Study Completion Date :
    Mar 2, 2023

    Outcome Measures

    Primary Outcome Measures

    1. clinical data [at diagnosis]

      pain (pain scale)

    2. biological data [at diagnosis]

      biology (CRP in mg/L)

    3. biological data [at diagnosis]

      presence of anti-SSA/SSB (yes/no)

    4. histological data [at diagnosis]

      accesories salivary glands biopsies (focus score)

    5. imaging data [at diagnosis]

      US (presence of shoulder involvement yes/no; hip involvement yes/no)

    6. treatments data [at inclusion ( day 0)]

      use of methotrexate yes/no; abatacept yes/no, rituximab yes/no, corticosteroids yes/no; pilocarpine yes/no; hydroxychloroquine yes/no

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU Brest Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05312944
    Other Study ID Numbers:
    • PASS (29BRC20.0176)
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2022