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TYSABRI Global Observational Program in Safety (TYGRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00477113
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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).

Condition or disease
Multiple Sclerosis

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
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Study Type : Observational
Actual Enrollment : 2207 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TYGRIS: TYSABRI® Global Observational Program in Safety
Study Start Date : January 2007
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with serious infections, malignancies, and other SAEs [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
whole blood, serum

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS patients treated with TYSABRI in North America
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477113


Locations
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United States, Missouri
There may be mulitple sites in this clinical trial. Contact United BioSource Corporation
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Additional Information:

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00477113    
Other Study ID Numbers: 101MS402
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015
Keywords provided by Biogen:
natalizumab
MS
Tysabri
Multiple Sclerosis
TYGRIS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases