TYSABRI® Global Observational Program in Safety (TYGRIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00477113
First received: May 21, 2007
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TYGRIS: TYSABRI® Global Observational Program in Safety

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of participants with serious infections, malignancies, and other serious adverse events (SAEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Enrollment: 2207
Study Start Date: January 2007
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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 TYSABRI® in a clinical practice setting in the United States or Canada.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477113

Locations
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 Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00477113     History of Changes
Other Study ID Numbers: 101MS402
Study First Received: May 21, 2007
Last Updated: June 12, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Tysabri®
natalizumab
MS
Multiple Sclerosis
TYGRIS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014