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

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

ofatumumab

Clinical Study ID

NCT06157086
COMB157GFR06
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thedoctor (investigator) in accordance with his/her usual practices independently ofthe study

  5. Patient not opposed to participation in this study

  6. Patient willing and able to complete patient questionnaires

Exclusion

Exclusion Criteria:

  1. Patient treated with ofatumumab in the context of a clinical trial

Study Design

Total Participants: 294
Treatment Group(s): 1
Primary Treatment: ofatumumab
Phase:
Study Start date:
December 21, 2023
Estimated Completion Date:
July 31, 2026

Study 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).

Connect with a study center

  • Novartis Investigative Site

    Agen 09, 47923
    France

    Active - Recruiting

  • Novartis Investigative Site

    Altkirch, 68130
    France

    Active - Recruiting

  • Novartis Investigative Site

    Amiens, 80054
    France

    Active - Recruiting

  • Novartis Investigative Site

    Angers Cedex 9, 49933
    France

    Active - Recruiting

  • Novartis Investigative Site

    Bethune, 62400
    France

    Active - Recruiting

  • Novartis Investigative Site

    Bordeaux Cedex, 33076
    France

    Active - Recruiting

  • Novartis Investigative Site

    Brest, 29200
    France

    Active - Recruiting

  • Novartis Investigative Site

    Cahors, 46000
    France

    Active - Recruiting

  • Novartis Investigative Site

    Chambery cedex, 73011
    France

    Active - Recruiting

  • Novartis Investigative Site

    Compiegne, 60200
    France

    Active - Recruiting

  • Novartis Investigative Site

    Contamine Sur Arve, 74130
    France

    Active - Recruiting

  • Novartis Investigative Site

    Dax, 40107
    France

    Active - Recruiting

  • Novartis Investigative Site

    Dax Cedex, 40107
    France

    Site Not Available

  • Novartis Investigative Site

    La Rochelle, 17019
    France

    Active - Recruiting

  • Novartis Investigative Site

    La Seyne Sur Mer, 83500
    France

    Active - Recruiting

  • Novartis Investigative Site

    Le Bouscat, 33110
    France

    Active - Recruiting

  • Novartis Investigative Site

    Le Coudray, 28630
    France

    Active - Recruiting

  • Novartis Investigative Site

    Lens, 62307
    France

    Active - Recruiting

  • Novartis Investigative Site

    Libourne, 33505
    France

    Active - Recruiting

  • Novartis Investigative Site

    Lille, 59000
    France

    Active - Recruiting

  • Novartis Investigative Site

    Lyon, 69275
    France

    Active - Recruiting

  • Novartis Investigative Site

    Mantes La Jolie, 78200
    France

    Active - Recruiting

  • Novartis Investigative Site

    Marseille 01, 13001
    France

    Active - Recruiting

  • Novartis Investigative Site

    Mont de Marsan cedex, 40024
    France

    Active - Recruiting

  • Novartis Investigative Site

    Montlucon, 03100
    France

    Active - Recruiting

  • Novartis Investigative Site

    Montpellier, 34295
    France

    Active - Recruiting

  • Novartis Investigative Site

    Mulhouse, 68100
    France

    Active - Recruiting

  • Novartis Investigative Site

    Nimes, 30029
    France

    Active - Recruiting

  • Novartis Investigative Site

    Orsay, 91400
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris, 75017
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris Cedex 12, F-75571
    France

    Active - Recruiting

  • Novartis Investigative Site

    Pointe A Pitre, 97159
    France

    Active - Recruiting

  • Novartis Investigative Site

    Poissy, 78303
    France

    Active - Recruiting

  • Novartis Investigative Site

    Pringy, 74374
    France

    Active - Recruiting

  • Novartis Investigative Site

    Reims, 51092
    France

    Active - Recruiting

  • Novartis Investigative Site

    Rennes, 35043
    France

    Active - Recruiting

  • Novartis Investigative Site

    Saint Maur Des Fosses, 94100
    France

    Active - Recruiting

  • Novartis Investigative Site

    Saverne, 67700
    France

    Active - Recruiting

  • Novartis Investigative Site

    Selestat, 67600
    France

    Active - Recruiting

  • Novartis Investigative Site

    Strasbourg, 67000
    France

    Active - Recruiting

  • Novartis Investigative Site

    Toulouse Cedex 9, 31059
    France

    Active - Recruiting

  • Novartis Investigative Site

    Tours, 37044
    France

    Active - Recruiting

  • Novartis Investigative Site

    Valence Cedex 9, 26953
    France

    Active - Recruiting

  • Novartis Investigative Site

    Villeurbanne, 69100
    France

    Active - Recruiting

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