TYSABRI® Global Observational Program in Safety (TYGRIS)
This study is ongoing, but not recruiting participants.
Sponsor:
Biogen Idec
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00477113
First received: May 21, 2007
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients 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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Natalizumab
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- To determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in patients with Multiple Sclerosis (MS) treated with Tysabri. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
whole blood, serum
| Enrollment: | 3000 |
| 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) |
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) patients 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
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.
Contacts and Locations
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
Elan Pharmaceuticals
More Information
Additional Information:
No publications provided
| Responsible Party: | Biogen Idec MD, Biogen Idec, Inc. |
| ClinicalTrials.gov Identifier: | NCT00477113 History of Changes |
| Other Study ID Numbers: | 101-MS-402 |
| Study First Received: | May 21, 2007 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
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 May 19, 2013