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NCT00477113 Clinical Trial

TYSABRI Global Observational Program in Safety

Multiple Sclerosis Clinical Trial

— TYGRIS  

Official title:
TYGRIS: TYSABRI® Global Observational Program in Safety

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00477113
Other study ID # 101MS402
Secondary ID
Status Completed
Phase N/A
First received May 21, 2007
Last updated June 18, 2015
Start date January 2007
Est. completion date May 2015

Study information
Verified date June 2015
Source Biogen
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Food and Drug Administration
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 (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab).

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.

Recruitment information / eligibility
Status Completed
Enrollment 2207
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States There may be mulitple sites in this clinical trial. Contact United BioSource Corporation Kansas City Missouri

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with serious infections, malignancies, and other SAEs 5 years Yes
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