A Study for Tysabri Participant Preference
NCT05304520 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 318
Last updated 2024-05-17
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.
Conditions
- Relapsing-Remitting Multiple Sclerosis (RRMS)
Interventions
- DRUG
-
Natalizumab
Administered as specified in the treatment arm.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Biogen
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-12
- Primary Completion
- 2024-04-30
- Completion
- 2024-04-30
- FDA Drug
- Yes
Countries
- Germany
Study Locations
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