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Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France

NCT ID: NCT06157086

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-21

Study Completion Date

2026-07-31

Brief Summary

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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

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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

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Multiple Sclerosis (MS)

Keywords

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MS Multiple sclerosis NIS ofatumumab Kesimpta QoL PRO

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ofatumumab

MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol

ofatumumab

Intervention Type OTHER

There is no treatment allocation. Participants with MS that initiated treatment with ofatumumabas per neurologist practice and regardless of the study protocol

Interventions

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ofatumumab

There is no treatment allocation. Participants with MS that initiated treatment with ofatumumabas per neurologist practice and regardless of the study protocol

Intervention Type OTHER

Other Intervention Names

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KESIMPTA

Eligibility Criteria

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Inclusion Criteria

1. Male or female, 18 years of age or older
2. Patient with confirmed MS diagnosis
3. Patient initiating treatment with ofatumumab for the first time
4. 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
5. Patient not opposed to participation in this study
6. Patient willing and able to complete patient questionnaires

Exclusion Criteria

1\. Patient treated with ofatumumab in the context of a clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Angers, France, France

Site Status

Novartis Investigative Site

Paris, France, France

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Novartis Investigative Site

Agen, , France

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Novartis Investigative Site

Altkirch, , France

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Novartis Investigative Site

Amiens, , France

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Belfort, , France

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Bordeaux, , France

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Boulogne-sur-Mer, , France

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Brest, , France

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Brunstatt Didenheim, , France

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Cahors, , France

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Chambéry, , France

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Cherbourg Octeville, , France

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Compiègne, , France

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Novartis Investigative Site

Contamine-sur-Arve, , France

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Novartis Investigative Site

Dax, , France

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Gonesse, , France

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Le Bouscat, , France

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Le Coudray, , France

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Lens, , France

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Libourne, , France

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Lille, , France

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Lille, , France

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Lyon, , France

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Lyon, , France

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Mantes-la-Jolie, , France

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Marseille 01, , France

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Meaux, , France

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Metz-Tessy, , France

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Mont-de-Marsan, , France

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Montluçon, , France

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Montpellier, , France

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Mulhouse, , France

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Nîmes, , France

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Orsay, , France

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Paris, , France

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Paris, , France

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Poissy, , France

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Quint-Fonsegrives, , France

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Reims, , France

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Rennes, , France

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Saverne, , France

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Sélestat, , France

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Strasbourg, , France

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Toulouse, , France

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Tours, , France

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Novartis Investigative Site

Valence, , France

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Novartis Investigative Site

Vannes, , France

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Novartis Investigative Site

Villeurbanne, , France

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Countries

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France

Other Identifiers

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COMB157GFR06

Identifier Type: -

Identifier Source: org_study_id