Tysabri Observational Program

Biogen6,620 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

6,620

Conditions

Relapsing-Remitting Multiple Sclerosis

Interventions

TysabriDRUG

According to the local prescribing information

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (419)

Outcomes

Primary Outcomes

Number of Participants with Serious Adverse Events (SAE)

Time frame: Up to 15 years

Secondary Outcomes

Annualized Relapse Rate (ARR)

A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. New or recurrent neurological symptoms that occur less than 30 days following the onset of a protocol-defined relapse should be considered part of the same relapse.