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

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: NCT00483847
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : April 13, 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 (SAEs) in participants with multiple sclerosis (MS) treated with TYSABRI (natalizumab).

Condition or disease
Multiple Sclerosis

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 4296 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World
Study Start Date : September 2006
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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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 serious adverse events (SAEs) [ Time Frame: 5 Years ]

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
Multiple Sclerosis (MS) participants treated with TYSABRI outside of North America
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.

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): NCT00483847


Locations
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Germany
There are multiple sites throughout Europe in this clinical trial. Contact Advanced Medical Services (AMS).
Mannheim, Germany, D-68167
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00483847    
Other Study ID Numbers: 101MS403
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015
Keywords provided by Biogen:
TYGRIS - Rest of World (ROW)
TYSABRI
natalizumab
Multiple Sclerosis
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