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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Phase: N/A

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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).

Clinical Details

Official title: TYGRIS - ROW: TYSABRIŽ Global Observational Program in Safety - Rest of World

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of participants with serious infections, malignancies, and other serious adverse events (SAEs)

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

There are multiple sites throughout Europe in this clinical trial. Contact Advanced Medical Services (AMS)., Mannheim D-68167, Germany
Additional Information

Starting date: September 2006
Last updated: April 9, 2015

Page last updated: August 23, 2015

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