Trials / Completed
CompletedNCT05304520
A Study for Tysabri Participant Preference
SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 318 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Natalizumab | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2021-10-12
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
- First posted
- 2022-03-31
- Last updated
- 2024-05-17
Locations
40 sites across 1 country: Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05304520. Inclusion in this directory is not an endorsement.