Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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®.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIUMVI® Exposed Cohort | Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception [DOC]). |
| |
| BRIUMVI® Unexposed Cohort | Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Major Congenital Malformations (MCMs) | Up to 52 weeks post-delivery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BRIUMVI® Pregnancy Registry Virtual Research Coordination Center | Contact | 1-877-411-4605 | briumvipregnancyregistry@ppd.com | |
| TG Therapeutics Clinical Support Team | Contact | 1-877-555-8489 | clinicalsupport@tgtxinc.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BRIUMVI® Pregnancy Registry Virtual Research Coordination Center | Recruiting | Wilmington | North Carolina | 28401-3331 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |