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Recruiting NCT07653984

Cohort Study on Neuroimmune Diseases in the Reproductive Age

— Observational Neuromyelitis Optica Spectrum Disorders (NMOSD) Multiple Sclerosis Autoimmune Encephalitis Myasthenia Gravis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis, Autoimmune Encephalitis, Myasthenia Gravis. Basic parameters: 20 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.

Primary outcome measures

  • Annual recurrence rate of neuroimmune diseases [Time frame: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.]
  • Demographic Characteristics [Time frame: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.]
  • Disease Duration and Initial Attack Status [Time frame: Assessed immediately from the time of enrollment for a maximum of 1 week.]
  • Lesion Location at Baseline [Time frame: Assessed immediately from the date of enrollment, up to 1 week.]
  • Visual Acuity and Visual Fields at Baseline [Time frame: Assessed immediately from the date of enrollment, up to 1 week.]
  • Prevalence of Comorbid Autoimmune Diseases [Time frame: Assessed immediately from the date of enrollment, up to 1 week.]
  • Maternal complication rates [Time frame: The assessment period is the gestation period of the pregnant woman, up to a maximum of 12 months.]
  • Obstetrical History: Number of Pregnancies and Miscarriages [Time frame: Assessed immediately from the date of enrollment, up to 1 week.]
  • Tryptophan derived neurotransmitter levels [Time frame: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.]
  • Expanded Disability Status Scale (EDSS) Score [Time frame: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.]

Eligibility criteria

Inclusion criteria

  • Patient Group: A total of fifty participants are expected to be enrolled.
  • Women aged 20-55 years with childbearing potential.
  • Voluntary informed consent.
  • Availability of complete personal information.
  • A confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), autoimmune encephalitis, myasthenia gravis, Guillain-Barré syndrome, or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

Healthy Control Group: A total of fifty healthy women are expected to be included.

  • Age- and sex-matched women of childbearing age with plans for pregnancy
  • Voluntary informed consent.
  • Availability of complete personal information.

Exclusion criteria

  • Patient Group:
  • Patients with an undetermined or unconfirmed diagnosis.
  • Incomplete personal information that cannot be obtained through follow-up.
  • Participants who voluntarily withdrew from the study and revoked informed consent.

Healthy Control Group:

  • Individuals diagnosed with neuroimmune-related disorders.
  • Incomplete personal information that cannot be obtained through follow-up.
  • Participants who voluntarily withdrew from the study and revoked informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Third Affiliated Hospital, Sun Yat-sen University — Guangzhou

Publications

  • Carra-Dalliere C, Rollot F, Deschamps R, Ciron J, Vukusic S, Audoin B, Ruet A, Maillart E, Papeix C, Zephir H, Laplaud D, Cohen M, Bourre B, El-Bahi I, Labauge P, Casey R, Ayrignac X, Marignier R. Pregnancy and post-partum in patients with myelin-oligodendrocyte glycoprotein antibody-associated disease. Mult Scler. 2023 Feb;29(2):270-276. doi: 10.1177/13524585221134214. Epub 2022 Dec 1. PMID 36453174
  • Longbrake E. Myelin Oligodendrocyte Glycoprotein-Associated Disorders. Continuum (Minneap Minn). 2022 Aug 1;28(4):1171-1193. doi: 10.1212/CON.0000000000001127. PMID 35938661
  • Cobo-Calvo A, Ruiz A, Marignier R. Myelin oligodendrocyte glycoprotein antibody associated disease: about the importance of diagnostic assays and selection of the target population in retrospective studies. Eur J Neurol. 2019 May;26(5):e58-e59. doi: 10.1111/ene.13896. No abstract available. PMID 30980491
  • Lupo J, Germi R, Jean D, Baccard-Longere M, Casez O, Besson G, Rouge A, Boutonnat J, Schwebel C, Hoffmann P, Morand P. Guillain-Barre syndrome and cytomegalovirus infection during pregnancy. J Clin Virol. 2016 Jun;79:74-76. doi: 10.1016/j.jcv.2016.04.010. Epub 2016 Apr 14. PMID 27105316
  • Pacheco LD, Saad AF, Hankins GD, Chiosi G, Saade G. Guillain-Barre Syndrome in Pregnancy. Obstet Gynecol. 2016 Nov;128(5):1105-1110. doi: 10.1097/AOG.0000000000001716. PMID 27741183
  • Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2. PMID 26948435
  • Magley J, Towner D, Tache V, Apperson ML. Pregnancy outcome in anti-N-methyl-D-aspartate receptor encephalitis. Obstet Gynecol. 2012 Aug;120(2 Pt 2):480-483. doi: 10.1097/AOG.0b013e31825935d4. PMID 22825272
  • Dalmau J, Graus F. Antibody-Mediated Encephalitis. N Engl J Med. 2018 Mar 1;378(9):840-851. doi: 10.1056/NEJMra1708712. No abstract available. PMID 29490181

Identifiers

NCT: NCT07653984 · 2024-309-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗