Ireland Natalizumab (TYSABRI) Observational Program (iTOP)

Biogen

Status: Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Biological: natalizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01943526

TYS-IRL-11-4

Details and patient eligibility

About

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

Full description

iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.

Enrollment: 191 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must give written informed consent and assent, as applicable.
• Decision to treat with natalizumab must precede enrollment.
• Patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information.
• Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with the natalizumab indication statement.
• Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.