TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of World

Multiple Sclerosis Clinical Trial

— TYGRIS - ROW  

Official title:

TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483847
• Other study ID #: 101MS403
• Status: Completed
• Phase: N/A
• First received: June 5, 2007
• Last updated: April 9, 2015
• Start date: September 2006
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéItaly: Ethics CommitteeAustria: EthikkommissionIreland: Irish Medicines BoardPortugal: National Pharmacy and Medicines InstituteUnited States: Institutional Review BoardAustria: Agency for Health and Food SafetyGermany: Ethics CommissionDenmark: The Regional Committee on Biomedical Research EthicsNetherlands: Medical Ethics Review Committee (METC)Germany: Federal Institute for Drugs and Medical DevicesIreland: Medical Ethics Research CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in participants with multiple sclerosis (MS) treated with TYSABRI (natalizumab).

Description:

The TYSABRI Global Observational Program in Safety for Rest of World (TYGRIS - ROW)is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with TYSABRI in a clinical practice setting in countries other than the United States and Canada.

The Prescribing Physician will collect participant information at routine clinic visits (using standard data collection tools) at approximately 6-month intervals for 5 years from the first TYSABRI infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4296
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Key Inclusion Criteria:

• All Multiple Sclerosis (MS) participants in Rest of World (ROW) who are prescribed and receiving TYSABRI in normal clinical practice at centers that are taking part in the study are eligible to participate in TYGRIS - ROW. Participants must have received at least 1 and not more than 3 infusions of TYSABRI.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
Germany	There are multiple sites throughout Europe in this clinical trial. Contact Advanced Medical Services (AMS).	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with serious infections, malignancies, and other serious adverse events (SAEs)		5 Years	Yes