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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00483847
First received: June 5, 2007
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World

Resource links provided by NLM:


Further study details as provided by Biogen:

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 ]

Enrollment: 4296
Study Start Date: September 2006
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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
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: NCT00483847

Locations
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
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00483847     History of Changes
Other Study ID Numbers: 101MS403
Study First Received: June 5, 2007
Last Updated: April 9, 2015
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Italy: Ethics Committee
Austria: Ethikkommission
Ireland: Irish Medicines Board
Portugal: National Pharmacy and Medicines Institute
United States: Institutional Review Board
Austria: Agency for Health and Food Safety
Germany: Ethics Commission
Denmark: The Regional Committee on Biomedical Research Ethics
Netherlands: Medical Ethics Review Committee (METC)
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Medical Ethics Research Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut

Keywords provided by Biogen:
TYGRIS - Rest of World (ROW)
TYSABRI
natalizumab
Multiple Sclerosis

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

ClinicalTrials.gov processed this record on September 02, 2015