Tysabri Observational Program (TOP)

Biogen

Status

Completed

Conditions

Relapsing-Remitting Multiple Sclerosis

Treatments

Drug: Tysabri

Study type

Observational

Funder types

Industry

Identifiers

NCT00493298

IMA-06-02

Details and patient eligibility

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.

Full description

TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.

Enrollment

6,620 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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.