For Healthcare Professionals

Tysabri Observational Program

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. Documented diagnosis of Relapsing Remitting Multiple Sclerosis
  2. The decision to treat with Tysabri must precede enrollment
  3. Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
  4. 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:


  1. History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
  2. History of positive anti-Tysabri antibodies
  3. Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
  4. Patient immunocompromised at the time of enrollment
  5. Known active malignancy
  6. 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.


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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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