Tysabri Observational Program

• Status: Active, not recruiting
• Trial end date: 2029-01-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of natalizumab in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Natalizumab

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-natalizumab 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.