A Study for Tysabri Participant Preference
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
Month 6
SafetyNumber of Participants by Their Preferred Method of Natalizumab Administration at Month 12
Month 12
Safety
Other measures (5)
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
Baseline, Months 3, 6, 9, and 12
RelapsesTime to Relapse
Baseline, Months 3, 6, 9, and 12
RelapsesNumber of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab
Baseline, Months 3, 6, 9, and 12
Disability progression
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Oct 2021
Main results due
Apr 2024
Finished
Apr 2024
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