Tysabri Observational Program
About the study
The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Documented diagnosis of Relapsing Remitting Multiple Sclerosis
- The decision to treat with Tysabri must precede enrollment
- Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
- Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri
EXCLUSION CRITERIA
Key Exclusion Criteria:
- History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
- History of positive anti-Tysabri antibodies
- Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
- Patient immunocompromised at the time of enrollment
- Known active malignancy
- Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Relapsing-Remitting Multiple Sclerosis
Age (in years)
18 - 65
Participants needed
6620
Est. Completion Date
Jan 3, 2029
Treatment type
Observational
Sponsor
Biogen
ClinicalTrials.gov identifier
NCT00493298
Study number
IMA-06-02
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