Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT05688436 · View on ClinicalTrials.gov ↗
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
Interventions
- DRUG Fingolimod
- DRUG Diroximel Fumarate
- BIOLOGICAL Alemtuzumab
- DRUG Glatiramer acetate
- BIOLOGICAL Interferon beta
Study Locations (1)
Minnesota
- OptumInsight — Eden Prairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,178 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2031-01-17 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05688436
The ClinicalTrials.gov registry entry for NCT05688436 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05688436 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05688436?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.