NCT06433765 A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
| NCT ID | NCT06433765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TG Therapeutics, Inc. |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 728 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2035-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 728 participants in total. It began in 2024-06-01 with a primary completion date of 2035-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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®.
Eligibility Criteria
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.
Contact & Investigator
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
✉ briumvipregnancyregistry@ppd.com📞 1-877-411-4605
Frequently Asked Questions
Who can join the NCT06433765 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 50 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06433765 currently recruiting?
Yes, NCT06433765 is actively recruiting participants. Contact the research team at briumvipregnancyregistry@ppd.com for enrollment information.
Where is the NCT06433765 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT06433765 clinical trial?
NCT06433765 is sponsored by TG Therapeutics, Inc.. The trial plans to enroll 728 participants.
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