Multiple Sclerosis (MS)SEPROSNCT06157086
Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France
An observational study of Multiple Sclerosis (MS), run by Novartis Pharmaceuticals at 49 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- ofatumumab
- How many people
- 302 participants
- Where
- 49 sitesFrance
- Study dates
- 21 Dec 2023to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adult patients with MS (women and men) who have initiated treatment with ofatumumab (Kesimpta ®).
Who may be able to join
- Male or female, 18 years of age or older
- Patient with confirmed MS diagnosis
- Patient initiating treatment with ofatumumab for the first time
- Patient for which the decision to initiate treatment with ofatumumab was made by the doctor (investigator) in accordance with his/her usual practices independently of the study
- Patient not opposed to participation in this study
- Patient willing and able to complete patient questionnaires
Who cannot join
- 1. Patient treated with ofatumumab in the context of a clinical trial
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
France49 sites
Novartis Investigative Site
Agen, 47923
Novartis Investigative Site
Altkirch, 68130
Novartis Investigative Site
Amiens, 80054
Novartis Investigative Site
Angers, France, 49933
Novartis Investigative Site
Belfort, 90000
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Boulogne-sur-Mer, 62200
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Brunstatt Didenheim, 68350
Novartis Investigative Site
Cahors, 46000
Novartis Investigative Site
Chambéry, 73000
Novartis Investigative Site
Cherbourg Octeville, 50102
Novartis Investigative Site
Compiègne, 60200
Novartis Investigative Site
Contamine-sur-Arve, 74130
Novartis Investigative Site
Dax, 40107
Novartis Investigative Site
Gonesse, 95503
Novartis Investigative Site
Le Bouscat, 33110
Novartis Investigative Site
Le Coudray, 28630
Novartis Investigative Site
Lens, 62307
Novartis Investigative Site
Libourne, 33505
Novartis Investigative Site
Lille, 59000
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Lyon, 69008
Novartis Investigative Site
Lyon, 69275
Novartis Investigative Site
Mantes-la-Jolie, 78200
Novartis Investigative Site
Marseille 01, 13001
Novartis Investigative Site
Meaux, 77104
Novartis Investigative Site
Metz-Tessy, 74374
Novartis Investigative Site
Mont-de-Marsan, 40024
Novartis Investigative Site
Montluçon, 03100
Novartis Investigative Site
Montpellier, 34090
Novartis Investigative Site
Mulhouse, 68100
Novartis Investigative Site
Nîmes, 30029
Novartis Investigative Site
Orsay, 91400
Novartis Investigative Site
Paris, France, F-75571
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Paris, 75017
Novartis Investigative Site
Poissy, 78303
Novartis Investigative Site
Quint-Fonsegrives, 31130
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Rennes, 35033
Novartis Investigative Site
Saverne, 67700
Novartis Investigative Site
Sélestat, 67600
Novartis Investigative Site
Strasbourg, 67000
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Tours, 37044
Novartis Investigative Site
Valence, 26953
Novartis Investigative Site
Vannes, 56017
Novartis Investigative Site
Villeurbanne, 69100
About this study
Official title: This is a Non-interventional, Prospective, Multicenter Study Conducted in France. The Primary Objective of This Study is to Describe the Quality of Life of MS Patients After Initiation of Treatment With Ofatumumab.
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.
Read the detailed description
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).
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- ofatumumab
- Keywords
- MS, Multiple sclerosis, NIS, ofatumumab, Kesimpta, QoL, PRO
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofatumumabOther
Also called KESIMPTA
There is no treatment allocation. Participants with MS that initiated treatment with ofatumumabas per neurologist practice and regardless of the study protocol
| Study group | Role | What they receive |
|---|---|---|
| ofatumumab | MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol Receives: Other: ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
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).
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 months
Ofatumumab discontinuation
Ofatumumab discontinuation by reason to be collected
Measured: 12 months
Persistence on ofatumumab
Patients still treated with ofatumumab at 6 and 12 months
Measured: Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start21 Dec 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157086
- Sponsor's protocol ID
- COMB157GFR06
- Acronym
- SEPROS
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Non-interventional, Prospective, Multicenter Study Conducted in France. The Primary Objective of This Study is to Describe the Quality of Life of MS Patients After Initiation of Treatment With Ofatumumab.
- ClinicalTrials.gov ID
- NCT06157086
- Acronym / sponsor ID
- SEPROS / COMB157GFR06
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- MS, Multiple sclerosis, NIS, ofatumumab, Kesimpta, QoL, PRO
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ofatumumab | – | Other: ofatumumabMS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult patients with MS (women and men) who have initiated treatment with ofatumumab (Kesimpta ®).
Key inclusion criteria (6 listed)
- Male or female, 18 years of age or older
- Patient with confirmed MS diagnosis
- Patient initiating treatment with ofatumumab for the first time
- Patient for which the decision to initiate treatment with ofatumumab was made by the doctor (investigator) in accordance with his/her usual practices independently of the study
- Patient not opposed to participation in this study
Key exclusion criteria (1 listed)
- 1. Patient treated with ofatumumab in the context of a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ofatumumabAlso: KESIMPTAThere is no treatment allocation. Participants with MS that initiated treatment with ofatumumabas per neurologist practice and regardless of the study protocol | Other | ofatumumab |
Primary outcome
Quality of life - MUSIQoL questionnaire
Time frame: 12 months
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.
8 secondary outcomes
Treatment satisfaction of patients treated with ofatumumab using TSQM 9 questionnaire
Time frame: 12 months
Impact of MS on professional activity using the 6-item WPAI questionnaire
Time frame: 12 months
Neurologist's decision criteria for initiating ofatumumab and patient involvement in the treatment choice
Time frame: Baseline
Clinical evolution of Multiple sclerosis - EDSS score
Time frame: 12 months
Clinical evolution of Multiple sclerosis - Number of patients with relapses
Time frame: Up to 12 months
Number of patient adherent to ofatumumab from patient and practitioner perspectives
Time frame: 12 months
Ofatumumab discontinuation
Time frame: 12 months
Persistence on ofatumumab
Time frame: Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS), run by Novartis Pharmaceuticals at 49 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life - MUSIQoL questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.