RecruitingMS (type not specified)NCT06433765

What it found

Still running

No result yet.

What was tested

Treatment tested

  • No intervention

What it measured

Main measures

  • Percentage of Participants with Major Congenital Malformations (MCMs)

    Up to 52 weeks post-delivery

Who could take part

MS (type not specified) · 15 to 50

Inclusion Criteria: 1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®. 2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy. 3. Diagnosis of MS. 4. Currently or recently (within 1 year of pregnancy outcome) pregnant. 5. Authorization from healthcare provider to provide data to registry. Exclusion Criteria: 1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy. 2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled). 3. Exposure to known teratogens and/or investigational medications during pregnancy.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.

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History

    1. Started

      Jun 2024

    2. Main results due

      Mar 2035

    3. Finished

      Mar 2035

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