A Study for Tysabri Participant Preference
- Registration Number
- NCT05304520
- Lead Sponsor
- Biogen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Natalizumab-Naive SC Cohort Natalizumab Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months. On Natalizumab: Switcher IV to SC Cohort Natalizumab 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. Natalizumab-Naive IV Cohort Natalizumab 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
- Primary Outcome Measures
Name Time Method Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12 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?".
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6 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?".
- Secondary Outcome Measures
Name Time Method Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab Baseline, Months 3, 6, 9, and 12 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.
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 Time to Relapse Baseline, Months 3, 6, 9, and 12 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 Baseline, Months 3, 6, 9, and 12 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.
Trial Locations
- Locations (40)
Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
🇩🇪Augsburg, Germany
Praxis Dr. Schöll
🇩🇪Bad Homburg, Germany
Caritas Krankenhaus Bad Mergentheim
🇩🇪Bad Mergentheim, Germany
Neurologische Praxis Dr. med. Boris-Alexander Kallmann
🇩🇪Bamberg, Germany
Marianne-Strauß-Klinik Starnberg
🇩🇪Berg, Germany
Neurologie am Mexikoplatz
🇩🇪Berlin, Germany
Neurologie im Tempelhofer Hafen Berlin
🇩🇪Berlin, Germany
Neurologisches Facharztzentrum Dr. Masri & Kollegen
🇩🇪Berlin, Germany
NFZB Neurologisches Facharztzentrum Berlin
🇩🇪Berlin, Germany
Praxis für Neurologie/Dr. med. Martin Delf
🇩🇪Berlin, Germany
Scroll for more (30 remaining)Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid🇩🇪Augsburg, Germany