TYSABRI® Global Observational Program in Safety (TYGRIS)
This study is ongoing, but not recruiting participants.
Sponsor:
Biogen Idec
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
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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:
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:
- 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) |
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
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 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 March 01, 2015