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

Biogen

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT00483847

101MS403

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4,296 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.