Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome (PASS)

March 28, 2022 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical data
Time Frame: at diagnosis
pain (pain scale)
at diagnosis
biological data
Time Frame: at diagnosis
biology (CRP in mg/L)
at diagnosis
biological data
Time Frame: at diagnosis
presence of anti-SSA/SSB (yes/no)
at diagnosis
histological data
Time Frame: at diagnosis
accesories salivary glands biopsies (focus score)
at diagnosis
imaging data
Time Frame: at diagnosis
US (presence of shoulder involvement yes/no; hip involvement yes/no)
at diagnosis
treatments data
Time Frame: at inclusion ( day 0)
use of methotrexate yes/no; abatacept yes/no, rituximab yes/no, corticosteroids yes/no; pilocarpine yes/no; hydroxychloroquine yes/no
at inclusion ( day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 2, 2021

Primary Completion (ANTICIPATED)

March 2, 2023

Study Completion (ANTICIPATED)

March 2, 2023

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (ACTUAL)

April 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PASS (29BRC20.0176)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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