NCT07821411Active, not recruiting
A Real-World Study of Ofatumumab in Multiple Sclerosis Patients in Germany and Japan
Real-World Outcomes of Ofatumumab: Relapse Rates, Disease Progression, and Treatment Patterns in Germany and Japan
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- 31 Jul 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT07821411
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 31 Jul 2026 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period.
- Other protocol-defined inclusion/exclusion criteria may apply.
Other
- Patients will be excluded if they meet any of the following criteria:
- Have inactive SPMS or primary progressive multiple sclerosis (PPMS).
Who the study is looking for
- Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria:
- Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS).
- Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT).
- Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period.
- Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death).
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.