Study Description
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).
Interventions
ofatumumab
Eligibility Criteria
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
Novartis Investigative Site
Recruiting
Lyon,69275,France
Novartis Investigative Site
Recruiting
Mulhouse,68100,France
Novartis Investigative Site
Recruiting
Valence Cedex 9,26953,France
Novartis Investigative Site
Recruiting
Altkirch,68130,France
Novartis Investigative Site
Recruiting
Dax Cedex,40107,France
Worldwide Contacts
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