Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome

• Conditions: Polymyalgia Rheumatica; Sjogren's Syndrome

• Registration Number: NCT05312944
• Lead Sponsor: University Hospital, Brest

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.

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 Timeline

• Study Start: 2021-03-02
• Study First Submitted: 2022-02-17
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
imaging data	at diagnosis	US (presence of shoulder involvement yes/no; hip involvement yes/no)
clinical data	at diagnosis	pain (pain scale)
biological data	at diagnosis	presence of anti-SSA/SSB (yes/no)
histological data	at diagnosis	accesories salivary glands biopsies (focus score)
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

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France