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Status unknownNCT05312944PASSUpdated Apr 6, 2022

Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome

An observational study in Polymyalgia Rheumatica and Sjogren's Syndrome, sponsored by University Hospital, Brest. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by University Hospital, Brest · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's planned enrollment of 15 is below the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 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 fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS

Inclusion criteria

  • fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. clinical data

    pain (pain scale)

    Time frame: at diagnosis

  2. biological data

    biology (CRP in mg/L)

    Time frame: at diagnosis

  3. biological data

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

    Time frame: at diagnosis

  4. histological data

    accesories salivary glands biopsies (focus score)

    Time frame: at diagnosis

  5. imaging data

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

    Time frame: at diagnosis

  6. treatments data

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

    Time frame: at inclusion ( day 0)

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2022, 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
NCT05312944
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Apr 6, 2022
Start date
Mar 2, 2021
Primary completion
Mar 2, 2023 (estimated)
Completion
Mar 2, 2023 (estimated)
Last update
Apr 6, 2022

Study contacts

Valerie Devauchelle-Pensec
Contact
valerie.devauchelle-pensec@chu-brest.fr
+332 9834 7264

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 status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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