Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting · NCT05658497 · Observational (researchers observe without assigning treatment) · Lead sponsor: Biogen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).
Who can take part
Inclusion criteria
- Participant must have a diagnosis of MS
- Documentation that the participant was one of the following:
- exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
- unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date)
- Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)
- Key
Exclusion criteria
- \- None
- NOTE: Other protocol defined Inclusion criteria may apply
Where it is running
8 locations listed across 2 US states.
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States
- IQVIA US Office - Durham, North Carolina, United States
- Inselspital - Bern, Switzerland
- St Vincent's University Hospital - Dublin, Ireland
- Austin Hospital - Heidelberg, Australia
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Salford Care Organization - Salford, Greater Manchester, United Kingdom
- Katholisches Klinikum Bochum - Bochum, North Rhine-Westphalia, Germany