Vaccine Coverage and Primary Sjögren'Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of vaccination coverage for influenza, pneumococcus and DTP in patients with pSS and investigated the reasons for non-vaccination.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

NCT05817669

Primary Sjögren's Syndrome

COMPLETED PHASE2

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

NCT04981145

Primary Sjögren's Syndrome

RECRUITING PHASE4

A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome

NCT04078386

Primary Sjögren's Syndrome

COMPLETED PHASE2

A Study of INCB050465 in Primary Sjögren's Syndrome

NCT03627065

Primary Sjögren's Syndrome

COMPLETED PHASE2

A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

NCT02334306

Primary Sjögren's Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A cross-sectional study was performed in pSS patients from two different French tertiary referral centers for autoimmune diseases (Paris-Bicêtre and Montpellier). From January 2016 to November 2017, questionnaires were randomly delivered to patients with pSS according to European-American Diagnostic Criteria (2002). Before completing the questionnaire, patients gave their consent to participate. This questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow (HL) to limit missing data.

Data collected in the questionnaire included previous vaccinations, reasons for non-vaccination, sources of vaccine proposition, and sociodemographic data including education level (Bachelor degree, and post-Bachelor degree education) and presence of young child(ren) (inferior 10 years old) at home. The following data was collected from the medical file: European-American Diagnostic Criteria (2002) for pSS, the most recent EULAR Sjögren's syndrome disease activity index (ESSDAI), comorbidities (chronic lung diseases, diabetes, chronic kidney diseases, chronic liver diseases, chronic heart diseases, cardiovascular comorbidities \[coronary or cerebral ischemia\] and severe neurological or muscle diseases), history of severe A cross-sectional study was performed in pSS patients from two different French tertiary referral centers for autoimmune diseases (Paris-Bicêtre and Montpellier). From January 2016 to November 2017, questionnaires were randomly delivered to patients with pSS according to European-American Diagnostic Criteria (2002). Before completing the questionnaire, patients gave their consent to participate. This questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow (HL) to limit missing data. Data collected in the questionnaire included previous vaccinations, reasons for non-vaccination, sources of vaccine proposition, and sociodemographic data including education level (Bachelor degree, and post-Bachelor degree education) and presence of young child(ren) (inferior 10 years old) at home. The following data was collected from the medical file: European-American Diagnostic Criteria (2002) for pSS, the most recent EULAR Sjögren's syndrome disease activity index (ESSDAI), comorbidities (chronic lung diseases, diabetes, chronic kidney diseases, chronic liver diseases, chronic heart diseases, cardiovascular comorbidities \[coronary or cerebral ischemia\] and severe neurological or muscle diseases), history of severe infection (requiring intravenous antibiotics or hospital admission), current smoking status, treatments used for pSS including hydroxychloroquine, immunosuppressive drugs (methotrexate, leflunomide, ciclosporine, azathioprine, mycophenolate mofetil) and biological disease-modifying anti-rheumatic drugs (bDMARDs).

For descriptive statistical analysis, mean more or less SD were used for continuous variables and frequencies (percentage) for categorical variables. To evaluate factors associated with up-to-date vaccination, the investigators compared categorical variables between patients with updated and non-updated influenza, pneumococcal or DTP vaccines by using the Fisher exact test or chi-square test as appropriate. Continuous variables (age, ESSDAI) were compared by Student t test. A binary logistic regression model was used for multivariate analysis to estimate the odds ratio (OR) of being vaccinated with the 95% confidence interval (CI). p\< 0.05 was considered statistically significant. All statistical analyses were performed with IBM SPSS 15 software.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Sjögren Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Primary Sjögren's syndrome

111 consecutive patients with primary Sjögren's syndrome (European-American 2002 criteria)

Questionnaire

Intervention Type OTHER

Questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow to limit missing data.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

Questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow to limit missing data.

Intervention Type OTHER