Last Update: Apr 26, 2024
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 Identifier:
Novartis Reference Number:COMB157GFR06
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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).

Multiple Sclerosis (MS)
Recruiting
294
Dec 21, 2023
Jan 31, 2026
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

ofatumumab

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

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

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