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Clinical Trials/NCT00477113
NCT00477113CompletedNot Applicable

TYGRIS: TYSABRI® Global Observational Program in Safety

Biogen1 site in 1 country2,207 target enrollmentStarted: January 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Biogen
Enrollment
2,207
Locations
1
Primary Endpoint
Number of participants with serious infections, malignancies, and other SAEs
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of participants with serious infections, malignancies, and other SAEs

Time Frame: 5 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Biogen
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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