An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera

Study identification

• EU PAS number:
  EUPAS1000000285
• Study ID:
  1000000285
• Official title and acronym:
  An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Sweden
• Study description:
  This study’s overall research question and objective is to assess and compare the long-term safety of Vumerity and Tecfidera in participants with newly exposed to treatment, especially with regard to the important potential risks of malignancies and serious and opportunistic infections.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Actual:27/03/2024

Study start date

Actual:08/06/2024

Date of interim report, if expected

Planned:01/05/2024

Date of final study report

Planned:01/06/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen-100%

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)

Other study registration identification numbers and links

272MS403,
NCT05767736

https://clinicaltrials.gov/study/NCT05767736?term=272ms403&rank=1