BlossoMS
Research type
Research Study
Full title
Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
IRAS ID
329148
Contact name
Brian Musoke
Contact email
Sponsor organisation
Biogen
Clinicaltrials.gov Identifier
Not Applicable, Not Applicable
Duration of Study in the UK
6 years, 7 months, 30 days
Research summary
Women of childbearing potential are a considerable segment of the patient population affected by Multiple Sclerosis (MS) and may be exposed to diroximel fumarate around the time of conception and during pregnancy. Therefore, it is important to evaluate, in a global pregnancy registry, how exposure to diroximel fumarate may affect pregnancy and infant outcomes. This study will be conducted in pregnant women with multiple sclerosis who were exposed to diroximel fumarate at any time from 2 weeks after the first day of their last menstruation period up through any time during pregnancy and compared with pregnancies among women with Multiple sclerosis who were exposed to dimethyl fumarate, women with MS who were exposed to other Disease Modifying Therapies, women with Multiple sclerosis who were unexposed to disease modifying treatments, and women without Multiple sclerosis.
The Coordinating Centre (CC) will collect data from patients with MS who become pregnant while being treated with DRF or who were unexposed to DMTs during their pregnancies. The CC will also collect data from the patients’ HCPs. DMF cohort data will be collected from the Tecfidera PASS (EUPAS3976) titled “Biogen DMF MS Pregnancy Exposure Registry”.Data for women with MS exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy_Registries_ will be provided by the Sponsor.
Patients enrolled will be followed up for relevant medical data collection for approximately 1 year after enrollment. Study will be conducted for 7,5 years.(Submission of Final report – April 2033).
REC name
South Central - Oxford C Research Ethics Committee
REC reference
26/SC/0108
Date of REC Opinion
25 Mar 2026
REC opinion
Favourable Opinion