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AzTrials

Rheumatoid ArthritisEGR2NCT02450396

Pregnancy and Medically Assisted Conception in Rare Diseases

An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective… Read more about this study

Who is it for?
Any age, women only
How many people
0 participants
Where
1 siteFrance
Study dates
Jun 2015to Dec 2025
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Woman with a rare and/or systemic disease Pregnancy confirmed by a positive beta-HCG assay or an obstetric ultrasound OR medically assisted conception procedure

Who may be able to join

  • Woman with a rare and/or systemic disease
  • Pregnancy confirmed by a positive beta-HCG assay or an obstetric ultrasound OR medically assisted conception procedure
  • Patient agreed to participate

Who cannot join

  • Adults under guardianship
  • People hospitalised without their consent and not protected by the law
  • Persons deprived of their liberty

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Cochin

    Paris, 75014

Other trials in France

About this study

Official title: Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases

Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care.

Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child.

For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.

Keywords
Rare diseases, pregnancy, pregnancy,
Medical subject headings
Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic, Lupus Erythematosus, Systemic, Antiphospholipid Syndrome, Sjogren's Syndrome, Scleroderma, Diffuse, Myositis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. "good" obstetric outcome

    It's a composite outcome . A pregnancy with no severe maternal complication (by the Epimoms* definition), live birth after 35 weeks' gestation, a birth weight >10th percentile of the general population and no infections (maternal and infant) during pregnancy and first year of follow up, respectively

    Measured: 35 week gestation until 1 year Post Partum

Secondary outcomes (3)

  1. Define the best therapeutic management strategies

    About the organisation of care (analysis of the effect on outcome of the number of ultrasound examinations and clinician visits, and the systematic planning of delivery)

    Measured: 2 years

  2. Conduct pharmacoepidemiologic studies

    Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).

    Measured: 2 years

  3. Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).

    Within an existing collection with (1) samples taken during the first trimester of pregnancy to analyse markers that might predict subsequent obstetric complications (cytokines, growth factors, enzymes) (2) with cord blood samples (which will, in particular, enable immunological and pharmacological analyses).

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: Abandonment of the study project

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02450396
Sponsor's protocol ID
NI13002
Other IDs
13.381bis
Acronym
EGR2
Status last verified
Mar 2026
First submitted
19 May 2015
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No

Publications

  • Hornez M, Molto A, Leroy M, Banneville B, Belkhir R, Chauvet E, Couderc M, Dernis E, Devauchelle-Pensec V, Frazier A, Gossec L, Gervais E, Marotte H, Richez C, Sellam J, Seror R, Le Guern V, Guettrot-Imbert G, Costedoat-Chalumeau N, Flipo RM, Letarouilly JG. Impact of postpartum on patients with rheumatoid arthritis and spondyloarthritis: an ancillary analysis of the GR2 prospective cohort. RMD Open. 2026 Apr 28;12(2):e006593. doi: 10.1136/rmdopen-2025-006593.

    PubMed 42049394

  • Dernoncourt A, Guettrot-Imbert G, Sentilhes L, Besse MC, Molto A, Queyrel-Moranne V, Besnerais ML, Lazaro E, Tieulie N, Richez C, Hachulla E, Sarrot-Reynauld F, Leroux G, Orquevaux P, London J, Sailler L, Souchaud-Debouverie O, Smets P, Godeau B, Pannier E, Murarasu A, Berezne A, Goulenok T, Morel N, Mouthon L, Duhaut P, Guern VL, Costedoat-Chalumeau N; Gr2 Study Group. Safety of Fertility Treatments in Women With Systemic Lupus Erythematosus: Data From a Prospective Population-Based Study. BJOG. 2025 Apr;132(5):614-624. doi: 10.1111/1471-0528.18050. Epub 2024 Dec 19.

    PubMed 39702994

  • Alle G, Guettrot-Imbert G, Larosa M, Murarasu A, Lazaro E, Morel N, Orquevaux P, Sailler L, Queyrel V, Hachulla E, Sarrot Reynauld F, Perard L, Berezne A, Morati-Hafsaoui C, Chauvet E, Richez C, Goulenok T, London J, Molto A, Urbanski G, Le Besnerais M, Langlois V, Leroux G, Souchaud-Debouverie O, Roussin CL, Poindron V, Blanchet B, Pannier E, Sentilhes L, Mouthon L, Le Guern V, Costedoat-Chalumeau N; GR2 Study Group. Hydroxychloroquine levels in pregnancy and materno-fetal outcomes in systemic lupus erythematosus patients. Rheumatology (Oxford). 2025 Mar 1;64(3):1225-1233. doi: 10.1093/rheumatology/keae302.

    PubMed 38837707

  • Murarasu A, Guettrot-Imbert G, Le Guern V, Yelnik C, Queyrel V, Schleinitz N, Ferreira-Maldent N, Diot E, Urbanski G, Pannier E, Lazaro E, Souchaud-Debouverie O, Orquevaux P, Belhomme N, Morel N, Chauvet E, Maurier F, Le Besnerais M, Abisror N, Goulenok T, Sarrot-Reynauld F, Deroux A, Pasquier E, de Moreuil C, Bezanahary H, Perard L, Limal N, Langlois V, Calas A, Godeau B, Lavigne C, Hachulla E, Cohen F, Benhamou Y, Raffray L, de Menthon M, Tieulie N, Poindron V, Mouthon L, Larosa M, Elefant E, Sentilhes L, Molto A, Deneux-Tharaux C, Costedoat-Chalumeau N; GR2 Study Group. Characterisation of a high-risk profile for maternal thrombotic and severe haemorrhagic complications in pregnant women with antiphospholipid syndrome in France (GR2): a multicentre, prospective, observational study. Lancet Rheumatol. 2022 Dec;4(12):e842-e852. doi: 10.1016/S2665-9913(22)00308-3. Epub 2022 Nov 24.

    PubMed 38261392

  • Larosa M, Le Guern V, Guettrot-Imbert G, Morel N, Abisror N, Morati-Hafsaoui C, Orquevaux P, Diot E, Doria A, Sarrot-Reynauld F, Limal N, Queyrel V, Souchaud-Debouverie O, Sailler L, Le Besnerais M, Goulenok T, Molto A, Pannier-Metzger E, Sentilhes L, Mouthon L, Lazaro E, Costedoat-Chalumeau N; GR2 Group. Evaluation of lupus anticoagulant, damage, and remission as predictors of pregnancy complications in systemic lupus erythematosus: the French GR2 study. Rheumatology (Oxford). 2022 Aug 30;61(9):3657-3666. doi: 10.1093/rheumatology/keab943.

    PubMed 35015828

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris 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 3 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: withdrawn, as of the sponsor's last update on 27 Mar 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 was withdrawn before enrolling participants, so there are no results.

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?

"good" obstetric outcome (time frame: 35 week gestation until 1 year Post Partum). 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 NCT02450396, which also lists 5 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 27 Mar 2026.

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