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.
Study Type
OBSERVATIONAL
Enrollment
318
Administered as specified in the treatment arm.
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?".
Time frame: 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?".
Time frame: Month 12
Number of Participants Positive for Anti-Natalizumab-Antibody
Time frame: Baseline, Month 6 and 12
Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody
Time frame: 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.
Time frame: Baseline, Months 3, 6, 9, and 12
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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
...and 30 more locations
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.
Time frame: 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.
Time frame: Baseline, Months 3, 6, 9, and 12