Arthritis, RheumatoidMARIGYNNCT05961267
Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
An observational study of Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 318 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2023to 28 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.
Who may be able to join
- Female patient over 18 years of age
- Non-menopausal patient (only for the subgroup of patients used to assess the use of effective contraception)
- Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.
- French-speaking patient with no comprehension problems
- Person affiliated with or benefiting from a social securitý scheme
- Patient who received information about the protocol and gavé her consent
Who cannot join
- Pregnant or breastfeeding patient
- Patient with a history of total hysterectomy
- Patient referred to in articles L 1121-5 to L 1121-8 (persons deprived of liberty by a judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
To evaluate the gynecological follow-up of patients with autoimmune diseases or inflammatory rheumatism by:
- Assessing the proportion of patients reporting having contraception described as effective by guidelines within one year in the study population.
- Evaluating the proportion of patients reporting having had a consultation for screening or follow-up for cervical dysplasia in the year.
Descriptive analysis of :
- Factors associated with effective contraceptive use and frequency of cervical smear screening.
- The impact of the disease on the pregnancy project.
- The appropriateness of the chosen contraceptive and the patients' comorbidities.
- The prevalence of Human Papillomavirus (HPV) infections, cervical dysplasia, cervical cancer in this French population at risk.
- Barriers to gynecological care.
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome, Mixed Connective Tissue Disease
- Being tested
- Questionnaire
- Keywords
- Auto-immune diseases, rare auto-immune diseases, contraception, gynecological follow-up
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome, Mixed Connective Tissue Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 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. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.
Measured: At baseline (Day 0)
Secondary outcomes (7)
Proportion of patients who report using effective contraception during the year.
Measured: At baseline (Day 0)
Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.
Measured: At baseline (Day 0)
Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.
Measured: At baseline (Day 0)
Prevalence of HPV infections in the study sample.
Measured: At baseline (Day 0)
Prevalence of cervical dysplasia in the study sample.
Measured: At baseline (Day 0)
Prevalence of cervical cancer in the study sample.
Measured: At baseline (Day 0)
Proportion of patients who report not having consulted their gynecologist during the year.
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start24 Jul 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe RICHEZ, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961267
- Sponsor's protocol ID
- CHUBX 2023/25
- Other IDs
- 2023-A01207-38
- Acronym
- MARIGYN
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uthurriague M, Delattre C, Barnetche T, Lazaro E, Truchetet ME, Hocke C, Mehsen-Cetre N, Bernard V, Richez C. Prevalence of effective contraceptive use among patients with rheumatic diseases: a descriptive study. BMC Rheumatol. 2026 Feb 12;10(1):25. doi: 10.1186/s41927-026-00616-0.
PubMed 41680954Delattre C, Uthurriague M, Barnetche T, Lambert M, Mehsen-Cetre N, Lazaro E, Truchetet ME, Hocke C, Richez C, Bernard V. Cervical cancer screening practices among patients with autoimmune and inflammatory rheumatic diseases: a descriptive cross-sectional observational study. BMC Womens Health. 2026 Apr 25;26(1):362. doi: 10.1186/s12905-026-04475-2.
PubMed 42035038
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
- ClinicalTrials.gov ID
- NCT05961267
- Acronym / sponsor ID
- MARIGYN / CHUBX 2023/25
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome, Mixed Connective Tissue Disease
- Keywords
- Auto-immune diseases, rare auto-immune diseases, contraception, gynecological follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To evaluate the gynecological follow-up of patients with autoimmune diseases or inflammatory rheumatism by:
- Assessing the proportion of patients reporting having contraception described as effective by guidelines within one year in the study population.
- Evaluating the proportion of patients reporting having had a consultation for screening or follow-up for cervical dysplasia in the year.
Descriptive analysis of :
- Factors associated with effective contraceptive use and frequency of cervical smear screening.
- The impact of the disease on the pregnancy project.
- The appropriateness of the chosen contraceptive and the patients' comorbidities.
- The prevalence of Human Papillomavirus (HPV) infections, cervical dysplasia, cervical cancer in this French population at risk.
- Barriers to gynecological care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: QuestionnairePatients with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.
Key inclusion criteria (6 listed)
- Female patient over 18 years of age
- Non-menopausal patient (only for the subgroup of patients used to assess the use of effective contraception)
- Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.
- French-speaking patient with no comprehension problems
- Person affiliated with or benefiting from a social securitý scheme
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding patient
- Patient with a history of total hysterectomy
- Patient referred to in articles L 1121-5 to L 1121-8 (persons deprived of liberty by a judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA 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. | Behavioural | Patients |
Primary outcome
Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.
Time frame: At baseline (Day 0)
7 secondary outcomes
Proportion of patients who report using effective contraception during the year.
Time frame: At baseline (Day 0)
Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.
Time frame: At baseline (Day 0)
Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.
Time frame: At baseline (Day 0)
Prevalence of HPV infections in the study sample.
Time frame: At baseline (Day 0)
Prevalence of cervical dysplasia in the study sample.
Time frame: At baseline (Day 0)
Prevalence of cervical cancer in the study sample.
Time frame: At baseline (Day 0)
Proportion of patients who report not having consulted their gynecologist during the year.
Time frame: At baseline (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Results publication: PubMed 41680954Uthurriague M, Delattre C, Barnetche T, Lazaro E, Truchetet ME, Hocke C, Mehsen-Cetre N, Bernard V, Richez C. Prevalence of effective contraceptive use among patients with rheumatic diseases: a descriptive study. BMC Rheumatol. 2026 Feb 12;10(1):25. doi: 10.1186/s41927-026-00616-0.
- Results publication: PubMed 42035038Delattre C, Uthurriague M, Barnetche T, Lambert M, Mehsen-Cetre N, Lazaro E, Truchetet ME, Hocke C, Richez C, Bernard V. Cervical cancer screening practices among patients with autoimmune and inflammatory rheumatic diseases: a descriptive cross-sectional observational study. BMC Womens Health. 2026 Apr 25;26(1):362. doi: 10.1186/s12905-026-04475-2.
- Individual participant dataSharing planned: No
Related trials for Arthritis, Rheumatoid
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe RICHEZ, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations. (time frame: At baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961267, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.