TYSABRI Global Observational Program in Safety

TYGRIS: TYSABRI® Global Observational Program in Safety

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00477113

Acronym

TYGRIS

Enrollment

2207

Registered

2007-05-22

Start date

2007-01-31

Completion date

2015-05-31

Last updated

2015-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

natalizumab, MS, Tysabri, Multiple Sclerosis, TYGRIS

Brief summary

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

Detailed description

The TYSABRI Global Observational Program in Safety (TYGRIS) is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with natalizumab in a clinical practice setting in the United States or Canada.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS. NOTE: Other protocol defined Inclusion/

Exclusion criteria

may apply.

Design outcomes

Primary

Measure	Time frame
Number of participants with serious infections, malignancies, and other SAEs	5 years

Countries

United States

Outcome results