Ireland Natalizumab (TYSABRI) Observational Program

Study Overview
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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.

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.

Official Title
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Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)

Conditions
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Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
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* Biological: natalizumab


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: natalizumab|Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing Serious Adverse Events (SAEs) |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability progression as determined by Expanded Disability Status Scale (EDSS) | Disability progression is defined as at least a 1.0 point increase on the EDSS from Baseline that is sustained over 6 months. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. | Up to 3 years | 
| MS disease activity as determined by 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. | Up to 3 years | 
| MS disease activity as determined by distribution of the total number of relapses during the study |  | Up to 3 years | 
| MS disease activity as determined by time to first relapse |  | Up to 3 years | 
| MS disease activity as determined by number of participants with relapse |  | Up to 3 years | 
| MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics | Prognostic factors for disability progression and MS disease activity will be assessed in different participant cohorts stratified according to their baseline characteristics: Participant demographics including age, gender; Disease History, including diagnosis and duration at baseline; Baseline EDSS; Number of relapses within 1 and 2 years before baseline; MRI parameters at baseline; Prior use of disease modifying therapy, anti-neoplastic, immunosuppressant or immunomodulator therapy | Up to 3 years | 
| MS disease activity as determined by MRI parameters |  | Up to 3 years | 
| Evaluation of short-term disease outcomes as assessed by EDSS progression |  | Up to 1 year | 
| Evaluation of short-term disease outcomes as assessed by occurrence of relapses |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ireland, Natalizumab