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

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

Recruiting
18-99 years
All
Phase N/A

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Overview

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.

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).

Eligibility

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

Study details
    Multiple Sclerosis (MS)

NCT06157086

Novartis Pharmaceuticals

23 January 2025

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