Ireland Natalizumab (TYSABRI) Observational Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Relapsing-Remitting Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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natalizumab

Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.

Intervention Type BIOLOGICAL

Other Intervention Names

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Tysabri BG00002

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No