Trials / Completed
CompletedNCT04353492
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab
A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 562 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.
Detailed description
This was a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ofatumumab | Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content) |
Timeline
- Start date
- 2020-07-14
- Primary completion
- 2024-10-09
- Completion
- 2025-03-11
- First posted
- 2020-04-20
- Last updated
- 2026-04-09
- Results posted
- 2025-11-12
Locations
123 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Estonia, Germany, Greece, Hungary, Italy, Latvia, Lebanon, Mexico, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04353492. Inclusion in this directory is not an endorsement.