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NCT05688436 · ClinicalTrials.gov registry record

A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

A clinical trial of Multiple Sclerosis, sponsored by Biogen.

Recruiting
Registry status
1,178
Enrollment target
1
Study location

NCT05688436 is a study of Multiple Sclerosis that is actively recruiting participants, run by Biogen. The registered enrollment target is 1,178 participants, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (103% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05688436, a study of Multiple Sclerosis, is actively recruiting participants, sponsored by Biogen.

RECRUITING
Registry status
1,178 participants
Enrollment target
1
Study location

Study Summary

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS. This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are: * Those who took DRF during their pregnancy * Those who took other drugs for RMS during their pregnancy, but not DRF * Those who did not take any drugs for RMS during their pregnancy The main question researchers want to learn about in this study is: • How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth. Researchers will also learn more about: * Loss of the baby before 20 weeks of pregnancy * Loss of the baby at and after 20 weeks of pregnancy * How many babies are born early (at or before 37 weeks) * How many babies are small for their age while in the participant's uterus * How many babies are born with any sign of life This study will be done as follows: * Participants with RMS can join this study if they become pregnant from 29th October 2019 to 31st July 2030. Information will start being collected when the participant decides to join the study. * The participants' medical records will be reviewed 2 times during the study - once when t

Conditions Studied

Multiple Sclerosis

Interventions

  • DRUG Fingolimod
  • DRUG Diroximel Fumarate
  • BIOLOGICAL Alemtuzumab
  • DRUG Glatiramer acetate
  • BIOLOGICAL Interferon beta

Study Locations (1)

Minnesota

  • OptumInsight - Eden Prairie

Trial Details

FieldValue
Enrollment Target 1,178 participants
Start Date 2021-09-24
Est. Completion 2031-01-17

Sponsor

Biogen

334 total trials

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What the Registry Record Tells You About NCT05688436

The ClinicalTrials.gov registry entry for NCT05688436 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,178 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (103% higher). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions - of which Fingolimod is the first listed.

NCT05688436 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT05688436 about?

NCT05688436 is a clinical study titled "A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies". In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called ...

What is the current status of trial NCT05688436?

This trial is currently recruiting. The enrollment target is 1,178 participants. The study started on 2021-09-24. Estimated completion is 2031-01-17.

What conditions does trial NCT05688436 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT05688436?

The interventions under investigation include: Fingolimod (DRUG), Diroximel Fumarate (DRUG), Alemtuzumab (BIOLOGICAL), Glatiramer acetate (DRUG), Interferon beta (BIOLOGICAL).

Who is sponsoring clinical trial NCT05688436?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05688436 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.