Last Update: Aug 12, 2024
A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice: the CRONOS-MS Study.
ClinicalTrials.gov Identifier:
Novartis Reference Number:COMB157GES01
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

This is a non-interventional, cross-sectional, multicentric, and nationwide study, based
on primary and secondary data collection. The present study aims to characterize the use of subcutaneous ofatumumab in a real-world
setting. Specifically, the investigation will assess the effectiveness, safety, and
treatment adherence associated with subcutaneous ofatumumab in individuals with relapsing
forms of multiple sclerosis (RMS) within the Spanish healthcare system.

The study will use primary and secondary data collection. Primary data collection
includes information collected using PRO, clinical-reported outcomes (ClinRO), scales or
tests and the interview during the study visit. Secondary data collection includes
existing data from electronic medical records (EMR) or paper-based medical records,
collected as part of the routine follow-up of patients with RMS in the clinical practice.

Baseline will be defined as the date of ofatumumab initiation.

Relapsing Forms of Multiple Sclerosis
Recruiting
310
Feb 26, 2024
Jan 15, 2025
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

ofatumumab

This is an observational study, there is no treatment allocation.

Eligibility Criteria

Inclusion Criteria:

1. Aged ≥ 18 years.

2. Written informed consent.

3. Diagnosis of RMS per McDonald Criteria (2017).

4. Ofatumumab treatment in line with the European Kesimpta® summary of product
characteristics (SmPC; i.e. adult patients with RMS with active disease defined by
clinical or imaging features) during at least 12 months and patients who
discontinued ofatumumab after receiving at least one dose with a minimum monitoring
of 12 months.

Exclusion Criteria:

1. Currently participating in a clinical trial.

2. Not able/unlikely to complete with all study activities according to investigator's
criteria.

3. Have a contraindication for ofatumumab use, according to the SmPC.

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