An observational study in Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Completed at 13 sites in Switzerland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Novartis Pharmaceuticals · Observational
This is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care.
This non-interventional study will observe the effect of Ofatumumab treatment compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS-COMB157G3301) in MS patients in a real-world setting in Switzerland over an observational period of 12 month.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 107 is close to the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and treated for at least 3 months with Ofatumumab
Exclusion Criteria:
Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis
Other: Ofatumumab
Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab, that have started before inclusion of the patient into the study will be enrolled.
Proportion of patients with no evidence of disease activity (NEDA-3)
No evidence of disease activity (NEDA-3), as defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening, as compared to the SoC arm of STHENOS.
Time frame: Month 12
Proportion of patients demonstrating NEDA-3
Proportion of patients demonstrating NEDA-3 and its components in relation to the Ofatumumab arm of STHENOS.
Time frame: Month 12
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3
Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3: * No confirmed MS relapse * No new or enlarging T2 lesions * No Gadolinium-positive T1 lesions * No six-month confirmed disability worsening
Time frame: Month 12
Proportion of patients with previous DMT medication
Proportion of patients with previous Disease-modifying Therapy (DMT) medication will be collected
Time frame: Baseline
Proportion of patients with clinical and MRI parameters
Proportion of patients with Magnet Resonance Imaging (MRI) and clinical parameters will be collected. Clinical parameters includes number of T2-hyperintense lesions, T1-contrast-enhancing lesions; number of MS relapse; Extended disability status scale (EDSS)
Time frame: Baseline
Proportion of Ofatumumab doses not completed
Proportion of Ofatumumab doses not completed and reason for not completion within 14 days of expected date.
Time frame: Month 12
Proportion of participants with a cumulative treatment interruption of more than six months
Proportion of participants with a cumulative treatment interruption of more than six months, calculated as 6 doses not completed.
Time frame: Month 12
Adherence to Ofatumumab
Proportion of participants with and without 100% adherence, defined as no dose administered outside of 14 days of expected date
Time frame: Month 12
Proportion of patients permanently discontinuing Ofatumumab
Proportion of patients permanently discontinuing Ofatumumab during the study, and reasons for discontinuation.
Time frame: Month 12
Interdependency of adherence and clinical outcome in terms of NEDA-3
Correlation between adherence and clinical outcome in terms of NEDA-3 activity to be measured
Time frame: Month 12
Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29
The Multiple Sclerosis Impact Scale (MSIS-29) Questionnaire is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options. Higher scores reflect greater impact on day to day life
Time frame: Month 12
Treatment satisfaction with Ofatumumab as measured by TSQM-9
The TSQM-9 is a patient questionnaire assessing treatment satisfaction with Ofatumumab. It consists of 3 subscales: effectiveness, convenience and global satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with treatment.
Time frame: Month 12
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals