An Observational Study Utilising Data from EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive Subcutaneous Administration of Natalizumab for Treatment of RRMS

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105827
• EU PAS number:
  EUPAS48753
• Study ID:
  105827
• Official title and acronym:
  An Observational Study Utilising Data from EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive Subcutaneous Administration of Natalizumab for Treatment of RRMS
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Denmark
• Study description:
  A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Planned: 30/06/2023

Study start date

Planned: 23/06/2023

Actual: 30/06/2023

Data analysis start date

Planned: 23/06/2023

Actual: 30/06/2023

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

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

101MS412