An observational study in Multiple Sclerosis (MS), sponsored by Novartis Pharmaceuticals. Active, not recruiting at 49 sites in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Novartis Pharmaceuticals · Observational
SEPROS is a non-interventional study, based on primary data collection of MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol.
This is a non-interventional, prospective (primary data), multicenter study conducted in metropolitan France. The primary objective of this study is to describe the quality of life of MS patients after initiation of treatment with ofatumumab.
In order to form a representative sample of MS patients taking into account the terms of care in France, free or practicing neurologists in healthcare institutions (public or private) in different regions of France will be selected to participate in this study.
The study will enroll adult patients with MS who initiated ofatumumab according to the physician's advice and independently of the study. Patients will be followed from initiation of ofatumumab either until (i) 12 months (± 1month) after initiation of ofatumumab (End of Study), or until (ii) discontinuation of treatment with ofatumumab prior to the completion of the 12-month follow-up (early termination); whichever occurs first (end of study or early termination).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 302 is above 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 be adult patients with MS (women and men) who have initiated treatment with ofatumumab (Kesimpta ®).
Exclusion Criteria:
1. Patient treated with ofatumumab in the context of a clinical trial
MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol
Other: ofatumumab
There is no treatment allocation. Participants with MS that initiated treatment with ofatumumabas per neurologist practice and regardless of the study protocol
Also known as: KESIMPTA
Quality of life - MUSIQoL questionnaire
The primary objective of this non-interventional study is to describe the quality of life of adult patients with MS treated with ofatumumab in real life, in France, after 12 months of treatment with ofatumumab using the MUSIQoL Quality of Life Questionnaire. The MuSiQoL measures MS-specific quality of life. It comprises 31 items covering 9 domains (activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, relationships with the healthcare system, sentimental and sexual life, coping, and rejection). Each item is scored on a 6-point Likert scale. The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0-100 scale. The global index score is computed as the mean of the dimension scores. Higher scores represent higher quality of life.
Time frame: 12 months
Treatment satisfaction of patients treated with ofatumumab using TSQM 9 questionnaire
TSQM -9 is a self-questionnaire used to assess patient satisfaction with their treatment. It is a validated questionnaire and a good predictor of compliance. It explores 4 dimensions of satisfaction (efficacy, side effects, simplicity and overall satisfaction), through 9 questions. Responses are expressed on a 7-point Likert scale to precisely capture the patient's point of view. The responses to the items are aggregated; thus, each dimension is noted between 0 (extremely dissatisfied) and 100 (extremely satisfied).
Time frame: 12 months
Impact of MS on professional activity using the 6-item WPAI questionnaire
The WPAI measures absence, presence, decreased work productivity, and reduction in normal daily activities over the past 7 days. This self-questionnaire is non-specific for a disease and is developed in 6 questions. It works to calculate a health-related deterioration score, which combines the absence score and presence score. This deterioration score is rated between 0 and 1 where 1 corresponds to the maximum score, i.e. stopping work
Time frame: 12 months
Neurologist's decision criteria for initiating ofatumumab and patient involvement in the treatment choice
For each patient included in the study, neurologist's decision criteria for ofatumumab initiation will be collected (i.e., patient characteristics and poor prognosis factors or reasons for treatment switch if applicable) as well as the involvement of the patient in the choice of treatment (yes or no)
Time frame: Baseline
Clinical evolution of Multiple sclerosis - EDSS score
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Time frame: 12 months
Clinical evolution of Multiple sclerosis - Number of patients with relapses
Number of patients with relapses and number of patients with hospitalizations related to the relapse
Time frame: Up to 12 months
Number of patient adherent to ofatumumab from patient and practitioner perspectives
Number of patient adherent to ofatumumab from patient and practitioner perspectives to be collected
Time frame: 12 months
Ofatumumab discontinuation
Ofatumumab discontinuation by reason to be collected
Time frame: 12 months
Persistence on ofatumumab
Patients still treated with ofatumumab at 6 and 12 months
Time frame: Month 6, Month 12
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals