CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 318 enrolled / 318 target
Drug / intervention
Questionnairebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05961267
NCT05961267N/ACompletedHigh Momentum (9.0/mo)Completion was 24mo ago

Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism

University Hospital, Bordeaux·observational·Posted Jul 27, 2023·Updated Jun 5, 2026

In Brief

An observational study evaluating Questionnaire for Arthritis, Rheumatoid and 5 related conditions. Completed, enrolled 318 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40. Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common. Several disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans. In addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear. In this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues. Studying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJul 27, 2023
Enrollment StartJul 24, 2023
Primary CompletionJun 28, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.9 years ago

Arms & Interventions

Patientsother

Patients with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.

Behavioral: Questionnaire

Interventions

Questionnairebehavioral

A gynecological follow-up questionnaire will be proposed to patients with one of the above mentioned pathologies. This is a standardized questionnaire specifically designed for this study.