A Study for Tysabri Participant Preference

Study Overview
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Brief Summary
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The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.

Official Title
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SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World

Conditions
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Relapsing-Remitting Multiple Sclerosis (RRMS)

Intervention / Treatment
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* Drug: Natalizumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC) In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC Key Exclusion Criteria: Progressive forms of MS Contraindication to natalizumab treatment according to natalizumab SmPC Concomitant treatment with other drugs for treating RRMS Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| On Natalizumab: Switcher IV to SC Cohort<br>Participants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months. | Drug: Natalizumab<br>* Administered as specified in the treatment arm.<br>|
| Natalizumab-Naive IV Cohort<br>Participants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months | Drug: Natalizumab<br>* Administered as specified in the treatment arm.<br>|
| Natalizumab-Naive SC Cohort<br>Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months. | Drug: Natalizumab<br>* Administered as specified in the treatment arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6 | The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. Are you satisfied with the route of administration of natalizumab? (yes/no) and indicate main reason. 2. For SC participants only- Have you experienced adverse events related to a subcutaneous injection. (1= mild to 5 = severe), and 3. If you had to choose between subcutaneous or intravenous route again, which route would you choose?. | Month 6 | 
| Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12 | The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. Are you satisfied with the route of administration of natalizumab? (yes/no) and indicate main reason. 2. For SC participants only- Have you experienced adverse events related to a subcutaneous injection. (1= mild to 5 = severe), and 3. If you had to choose between subcutaneous or intravenous route again, which route would you choose?. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Positive for Anti-Natalizumab-Antibody |  | Baseline, Month 6 and 12 | 
| Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody |  | Baseline, Month 6 and 12 | 
| Annual Relapse Rate | An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. Annual relapse rate is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years. | Baseline, Months 3, 6, 9, and 12 | 
| Time to Relapse | An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. | Baseline, Months 3, 6, 9, and 12 | 
| Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab | Progression is defined as an increase of at least 1.5 points from a baseline Expanded Disability Status Scale (EDSS) score of 0, or at least 1.0 point from a baseline EDSS score >0 and ≤5.5 points, or at least 0.5 point from a baseline EDSS score ≥6.0. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is reported. Improvement is defined analogously, and all other cases are considered as stable disease. | Baseline, Months 3, 6, 9, and 12 |