Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome

Sjogren's Syndrome Clinical Trial

— PASS  

Official title:

Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome : A French Multicentric Retrospective Study (PASS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312944
• Other study ID #: PASS (29BRC20.0176)
• Status: Recruiting
• Start date: March 2, 2021
• Est. completion date: March 2, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Brest
• Contact: Valerie Devauchelle-Pensec
• Phone: +332 9834 7264
• Email: valerie.devauchelle-pensec[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS Exclusion Criteria: -

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica
• Sjogren's Syndrome
• Syndrome

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical data	pain (pain scale)	at diagnosis
Primary	biological data	biology (CRP in mg/L)	at diagnosis
Primary	biological data	presence of anti-SSA/SSB (yes/no)	at diagnosis
Primary	histological data	accesories salivary glands biopsies (focus score)	at diagnosis
Primary	imaging data	US (presence of shoulder involvement yes/no; hip involvement yes/no)	at diagnosis
Primary	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)