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

• PURI:
  https://redirect.ema.europa.eu/resource/106698
• 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

Study protocol

Initial protocol

GB-TYS-12163 Protocol V2 Final 01Dec2022 Redacted.pdf

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