NCT05312944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

February 17, 2022

Last Update Submit

March 28, 2022

Conditions

Polymyalgia RheumaticaSjogren's Syndrome

Outcome Measures

Primary Outcomes (6)

  • clinical data

    pain (pain scale)

    at diagnosis

  • biological data

    biology (CRP in mg/L)

    at diagnosis

  • biological data

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

    at diagnosis

  • histological data

    accesories salivary glands biopsies (focus score)

    at diagnosis

  • imaging data

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

    at diagnosis

  • treatments data

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

    at inclusion ( day 0)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Polymyalgia RheumaticaSjogren's Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesArthritis, RheumatoidArthritisJoint DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Valerie Devauchelle-Pensec

CONTACT

+332 9834 7264valerie.devauchelle-pensec@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

April 6, 2022

Study Start

March 2, 2021

Primary Completion

March 2, 2023

Study Completion

March 2, 2023

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

FR(1)