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Tysabri Observational Program

Sponsored by Biogen

About this trial

Last updated 3 years ago

Study ID

IMA-06-02

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 18 years ago

What is this trial about?

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.

What are the Participation Requirements?

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

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.