An Observational, Cross-Sectional Survey to Assess PML Risk Awareness and Understanding from Patients’ Perspective and Effectiveness of the Tysabri (Natalizumab) Patient Alert Card in the UK (T-PAC)

Study identification

• EU PAS number:
  EUPAS106690
• Study ID:
  106698
• Official title and acronym:
  An Observational, Cross-Sectional Survey to Assess PML Risk Awareness and Understanding from Patients’ Perspective and Effectiveness of the Tysabri (Natalizumab) Patient Alert Card in the UK (T-PAC)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Study examining patients reponses to the issued patient alert card for Tysabri via the UK MS Register.
• Study status:
  Finalised

Research institutions and networks

Institutions

UK MS Register

Swansea University

Study timelines

Date when funding contract was signed

Planned:17/04/2023

Actual:18/04/2023

Study start date

Planned:14/05/2023

Actual:15/05/2023

Data analysis start date

Planned:24/06/2023

Actual:24/06/2023

Date of interim report, if expected

Planned:28/09/2023

Actual:28/09/2023

Date of final study report

Planned:30/11/2023

Actual:11/12/2023

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

GB-TYS-12163