Clinical trial NCT06551519: A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
Official title: A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis (FILAXOS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
MS
Ofatumumab
NIS
Germany
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-08-13
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple sclerosis patients currently treated with a DMT category 1 prior to study start and receive sNfL measurements

Brief summary: This is a prospective, multicenter, observational, non-interventional study (NIS) in patients with Multiple Sclerosis (MS) and routinely assessed serum neurofilament light (sNfL) values in Germany

Detailed description: Prospective, primary data will be collected from patients with sNfL outcomes in the context of switching to ofatumumab or continuing their current therapy. Data collection will cover a maximum period of 24 months.

The observational period will not be dictated by the protocol. Baseline and follow-up visits will take place at a frequency defined as per Investigator´s discretion following clinical routine. The diagnostic or monitoring procedures are only those ordinarily applied to therapeutic strategy and routine clinical care. During the observation phase of the study, data will be collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).

Eligible participants for the study are patients who have received treatment with category 1 DMTs and those who have included sNfL into their treatment decision-making process. These patients have the option to either continue their current DMT or switch to ofatumumab. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide. The decision to switch to ofatumumab or to continue the current DMT category 1 therapy must be made by the treating physician independently of the decision to enroll the patient in the study.

Eligibility criteria: Inclusion Criteria:

Participants eligible for inclusion in this study must meet all the following criteria:

1. Written informed consent must be obtained before participation in the study.
2. RMS patients aged 18 or older.
3. Treated in label with EU-approved DMTs for MS category 1 according to current guidelines (Hemmer et al 2023) for at least the last 3 months.
4. Presence of a sNfL test result from a commercially available test not older than 3 months.

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study:

1. Patients being treated outside of the approved label of the respective DMT.
2. Simultaneous participation in any interventional study or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab.

Primary outcomes:
measure: Proportion of patients with high serum neurofilament light (sNfL) levels
timeFrame: Up to 24 months
Secondary outcomes:
measure: sNfL use as a biomarker for Multiple Sclerosis disease activity in clinical practice
timeFrame: Up to 24 months
measure: Proportion of patients demonstrating radiological and / or clinical activity
timeFrame: Up to 24 months
measure: Proportion of patients with no evidence of disease activity (NEDA)
timeFrame: Baseline, month 12 and month 24
measure: Proportion of patients demonstrating NEDA 3 and its individual components at 24 months as compared to Baseline
timeFrame: Baseline, 24 months
measure: Proportion of patients perceived as clinically stable depending on sNfL level
timeFrame: Up to 24 months
measure: Multiple sclerosis impact scale 29 (MSIS-29)
timeFrame: Up to 24 months
measure: Fatigue questionnaire: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: Up to 24 months
measure: EuroQol- 5 Dimension (EQ-5D) score
timeFrame: Up to 24 months
measure: Number of participants using Ekiva MS App
timeFrame: Up to 24 months
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) score
timeFrame: Up to 24 months
measure: Reasons for and proportion of patients switching from current DMTs to ofatumumab
timeFrame: Up to 24 months
measure: Proportion of missed ofatumumab doses within one year,
timeFrame: Month 12
measure: Proportion of patients who continue to receive their initial treatment
timeFrame: Month 12 and month 24
measure: Reasons for, number of and duration of treatment interruptions and discontinuations.
timeFrame: Up to 24 months
measure: Duration of treatment interruptions and discontinuations.
timeFrame: Up to 24 months
measure: Characterization of patient subgroups with and without 100% adherence
timeFrame: Month 12
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Untermeiting
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Bad Homburg
country: Germany
facility: Novartis Investigative Site
state: Hesse
city: Meerbusch
country: Germany
facility: Novartis Investigative Site
state: North Rhine-Westfalia
city: Bad Krozingen
country: Germany
facility: Novartis Investigative Site
city: Bergneustadt
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bogen
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Itzehoe
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Remscheid
country: Germany
facility: Novartis Investigative Site
city: Salzatal OT Salzmuende
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Sundern Hachen
country: Germany
facility: Novartis Investigative Site
city: Tirschenreuth
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: