Trials / Completed
CompletedNCT04940065
Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen
Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen (Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 367 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 0 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This study was an uncontrolled, central registration system, open-label, multicenter observational study in patients using Kesimpta for the labeled indication.
Detailed description
This was a primary data collection-based special drug-use surveillance to be conducted in accordance with the GPSP ordinance. Observational period lasted 24 months from the start of treatment with Kesimpta.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Kesimpta | Prospective observational cohort study. There was no treatment allocation. |
Timeline
- Start date
- 2021-06-30
- Primary completion
- 2024-12-12
- Completion
- 2024-12-12
- First posted
- 2021-06-25
- Last updated
- 2025-11-28
Locations
103 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04940065. Inclusion in this directory is not an endorsement.