TG1101-RMS404 - A Post-Authorization Study to Characterize the Safety of BRIUMVI (ublituximab) Use in Pregnant Patients with Multiple Sclerosis Using Data from a US Administrative Healthcare Claims Database

Study identification

• EU PAS number:
  EUPAS1000000612
• Study ID:
  1000000612
• Official title and acronym:
  TG1101-RMS404 - A Post-Authorization Study to Characterize the Safety of BRIUMVI (ublituximab) Use in Pregnant Patients with Multiple Sclerosis Using Data from a US Administrative Healthcare Claims Database
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The objective of this retrospective cohort study is to assess pregnancy and infant outcomes among pregnant individuals with multiple sclerosis (MS) who were exposed to BRIUMVI during pregnancy, compared to two unexposed patient groups: ; (a) Disease-matched pregnant individuals exposed to other MS therapies and ; (b) Disease-matched pregnant individuals who were not exposed to any treatment for MS at the time of the ; estimated start of pregnancy (estimated date of conception (EDC)) or at any time during pregnancy.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Neuraxpharm Pharmaceuticals, S.L.

Study timelines

Date when funding contract was signed

Planned:29/01/2023

Actual:03/05/2023

Study start date

Planned:01/04/2024

Actual:18/12/2024

Data analysis start date

Planned:29/01/2034

Date of interim report, if expected

Planned:29/01/2034

Date of final study report

Planned:01/01/2036

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)