TG1101-RMS402

Study identification

• EU PAS number:
  EUPAS1000000611
• Study ID:
  1000000611
• Official title and acronym:
  TG1101-RMS402
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The overall objective of the study is to characterize the long-term safety of ublituximab in adult patients diagnosed with relapsing multiple sclerosis (RMS) in a post-approval real-world setting.; ; The primary objective of the study is to estimate the incidence rate of long-term safety events of interest, including total malignancies (including non-melanoma skin cancer [NMSC]), malignancies (excluding NMSC) (delayed-onset) and serious infections (acute-onset), in patients treated with ublituximab for RMS, as compared to RMS patients treated with other approved disease-modifying therapies (DMTs).; ; The secondary objectives of this study are:; - To estimate the incidence rate of NMSC in patients treated with ublituximab for RMS as compared to RMS patients treated with other approved DMTs.; - To assess the overall safety of ublituximab in patients with RMS as compared to patients with RMS exposed to other approved DMTs
• Study status:
  Ongoing

Research institutions and networks

Institutions

Neuraxpharm Pharmaceuticals, S.L.

Networks

German MS Society MS Registry

Study timelines

Date when funding contract was signed

Planned: 29/03/2023

Actual: 29/01/2025

Study start date

Planned: 18/12/2024

Actual: 18/12/2024

Data analysis start date

Planned: 29/01/2034

Date of interim report, if expected

Planned: 01/01/2034

Date of final study report

Planned: 01/06/2034

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 1 (imposed as condition of marketing authorisation)