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Ireland Natalizumab (TYSABRI) Observational Program (iTOP)

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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.

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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