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Multiple SclerosisFILAXOSNCT06551519

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

An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 82 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
ofatumumab and DMT category 1
How many people
519 participants
Where
82 sitesGermany
Study dates
23 Oct 2024to 29 Nov 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Multiple sclerosis patients currently treated with a DMT category 1 prior to study start and receive sNfL measurements

Who may be able to join

  • Participants eligible for inclusion in this study must meet all the following criteria:
  • Written informed consent must be obtained before participation in the study.
  • RMS patients aged 18 or older.
  • 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.
  • Presence of a sNfL test result from a commercially available test not older than 3 months.

Who cannot join

  • Participants meeting any of the following criteria are not eligible for inclusion in this study:
  • Patients being treated outside of the approved label of the respective DMT.
  • Simultaneous participation in any interventional study or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab.

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

Germany82 sites

  • Novartis Investigative Site

    Aalen, 73433

  • Novartis Investigative Site

    Albstadt, Baden-Wurttemberg, 72458

  • Novartis Investigative Site

    Altenholz, 24161

  • Novartis Investigative Site

    Augsburg, 86150

  • Novartis Investigative Site

    Backnang, 71522

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Bamberg, Bavaria, 96052

  • Novartis Investigative Site

    Bergneustadt, 51702

  • Novartis Investigative Site

    Berlin, 10437

  • Novartis Investigative Site

    Berlin, 12099

  • Novartis Investigative Site

    Berlin, 12163

  • Novartis Investigative Site

    Berlin, 14057

  • Novartis Investigative Site

    Berlin, 14169

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bogen, 94327

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Chemnitz, Saxony, 09117

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Coburg, 96450

  • Novartis Investigative Site

    Dillingen Saar, 66763

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia, 44135

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia, 44287

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Dresden, 01067

  • Novartis Investigative Site

    Duisburg, 47138

  • Novartis Investigative Site

    Düsseldorf, 40211

  • Novartis Investigative Site

    Eisleben Lutherstadt, 06295

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

  • Novartis Investigative Site

    Erfurt, 99096

  • Novartis Investigative Site

    Essen, 45138

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 65929

  • Novartis Investigative Site

    Gelsenkirchen, North Rhine-Westphalia, 45894

  • Novartis Investigative Site

    Gelsenkirchen, 45879

  • Novartis Investigative Site

    Görlitz, Saxony, 02828

  • Novartis Investigative Site

    Hagen, 58099

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg, 22297

  • Novartis Investigative Site

    Hamburg, 22179

  • Novartis Investigative Site

    Heidenheim, 89518

  • Novartis Investigative Site

    Herford, 32049

  • Novartis Investigative Site

    Höxter, 37671

  • Novartis Investigative Site

    Itzehoe, 25524

  • Novartis Investigative Site

    Jena, Thuringia, 07740

  • Novartis Investigative Site

    Karlsruhe, 76133

  • Novartis Investigative Site

    Kassel, Hesse, 34121

  • Novartis Investigative Site

    Katzenelnbogen, 56368

  • Novartis Investigative Site

    Leipzig, Saxony, 04299

  • Novartis Investigative Site

    Leipzig, Saxony, 04315

  • Novartis Investigative Site

    Leipzig, 04109

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68163

  • Novartis Investigative Site

    Meerbusch, North Rhine-Westphalia, 40667

  • Novartis Investigative Site

    Merzig, 66663

  • Novartis Investigative Site

    Minden, 32423

  • Novartis Investigative Site

    Mühlhausen, Thuringia, 99974

  • Novartis Investigative Site

    München, 80939

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Neuburg A.d. Donau, Bavaria, 86633

  • Novartis Investigative Site

    Neuwied, 56564

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Pforzheim, 75172

  • Novartis Investigative Site

    Quakenbrück, Lower Saxony, 49610

  • Novartis Investigative Site

    Regensburg, Bavaria, 93059

  • Novartis Investigative Site

    Remscheid, 42853

  • Novartis Investigative Site

    Rülzheim, 76761

  • Novartis Investigative Site

    Salzatal, 06198

  • Novartis Investigative Site

    Schwäbisch Hall, 74523

  • Novartis Investigative Site

    Schwetzingen, Baden-Wurttemberg, 68723

  • Novartis Investigative Site

    Siegen, North Rhine-Westphalia, 57072

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Singen, 78224

  • Novartis Investigative Site

    Sinsheim, 74889

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Sundern Sauerland, North Rhine-Westphalia, 59846

  • Novartis Investigative Site

    Tirschenreuth, 95643

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Unterhaching, Bavaria, 82008

  • Novartis Investigative Site

    Untermeitingen, Bavaria, 86836

  • Novartis Investigative Site

    Velbert, 42551

  • Novartis Investigative Site

    Weiden in Der Oberpfalz, Bavaria, 92637

  • Novartis Investigative Site

    Weil der Stadt, 71263

  • Novartis Investigative Site

    Wolfenbüttel, 38300

Other trials in Germany

About this study

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)

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

Read the 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.

Being tested
ofatumumab, DMT category 1
Keywords
Multiple sclerosis, MS, Ofatumumab, NIS, Germany
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ofatumumabOther

    This is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement.

  • DMT category 1Other

    This is an observational study. There is no treatment allocation. The decision to continue their current DMT will be based solely on clinical judgement.

Study groups in NCT06551519
Study groupRoleWhat they receive
OfatumumabPatients who have received treatment with category 1 DMTs and decided to switch to ofatumumab
Receives: Other: ofatumumab
Category 1 DMTsPatients who continued with DMT category 1 treatment. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide.
Receives: Other: DMT category 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with high serum neurofilament light (sNfL) levels

    Proportion of patients with high serum neurofilament light (sNfL) levels within 24 months of observation

    Measured: Up to 24 months

Secondary outcomes (16)

  1. sNfL use as a biomarker for Multiple Sclerosis disease activity in clinical practice

    Description of perception, utility, frequency of serum neurofilament light (sNfL) measurements and clinical consequences initiated by the treating physician in clinical routine care setting

    Measured: Up to 24 months

  2. Proportion of patients demonstrating radiological and / or clinical activity

    Proportion of patients demonstrating radiological (number of new/enlarging T2 lesions, number of Gadolinium-positive T1 lesions) and / or clinical activity (MS relapse, confirmed disability progression) at Baseline and throughout the study also in context with sNfL level.

    Measured: Up to 24 months

  3. Proportion of patients with no evidence of disease activity (NEDA)

    Proportion of patients with NEDA at 12 and 24 months as compared to Baseline also in context with sNfL level.

    Measured: Baseline, month 12 and month 24

  4. Proportion of patients demonstrating NEDA 3 and its individual components at 24 months as compared to Baseline

    NEDA is defined by no confirmed multiple sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.

    Measured: Baseline, 24 months

  5. Proportion of patients perceived as clinically stable depending on sNfL level

    Proportion of patients perceived as clinically stable depending on sNfL level

    Measured: Up to 24 months

  6. Multiple sclerosis impact scale 29 (MSIS-29)

    The Multiple Sclerosis Impact Scale version 2 will be used to assess health-related quality of life. MSIS-29 is a 29-item, self-administered questionnaire that includes two domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day-to-day life.

    Measured: Up to 24 months

  7. Fatigue questionnaire: Fatigue Scale for Motor and Cognitive Functions (FSMC)

    FSMC consists of 20 items (10 for cognitive fatigue [FSMCcog] and 10 for motor fatigue [FSMCmot]) with 1-5 points per item. The total possible score ranges from 20-100 points. A sum score of ≥43 is categorized as mild fatigue, ≥53 as moderate fatigue and ≥63 as severe fatigue.

    Measured: Up to 24 months

  8. EuroQol- 5 Dimension (EQ-5D) score

    This patient questionnaire is a generic multidimensional measure of health-related quality of life (EuroQol 1990). The five domains of mobility, ability to take care of oneself, everyday activities, pain/discomfort and anxiety/depression are considered. For each dimension, the most appropriate answer is selected from three given possibilities (1=no problem, 2=moderate problem, 3=big problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health).

    Measured: Up to 24 months

  9. Number of participants using Ekiva MS App

    Change in satisfaction scores and evaluation of improvement of patient-physician dialogue and Multiple Sclerosis patient management

    Measured: Up to 24 months

  10. Treatment Satisfaction Questionnaire for Medication (TSQM) score

    The TSQM Version 1.4 comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the subject´s last use. With the exception of item 4 (presence of side effects; yes or no), all items have 5 or 7 responses, scored from 1 (least satisfied) to 5 or 7 (most satisfied). The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow precise information to be obtained at the upper end of the score distribution. Item scores are summarized to give four domain scores, which are in turn transformed to a scale of 0-100.

    Measured: Up to 24 months

  11. Reasons for and proportion of patients switching from current DMTs to ofatumumab

    Reasons for and proportion of patients switching from current DMTs to ofatumumab depending on sNfL level

    Measured: Up to 24 months

  12. Proportion of missed ofatumumab doses within one year,

    Proportion of missed ofatumumab doses within one year, defined as the difference between number of planned doses and number of administered doses.

    Measured: Month 12

  13. Proportion of patients who continue to receive their initial treatment

    Proportion of patients who continue to receive their initial treatment (ofatumumab or DMT category 1)

    Measured: Month 12 and month 24

  14. Reasons for, number of and duration of treatment interruptions and discontinuations.

    Reasons for and number of treatment interruptions and discontinuations.

    Measured: Up to 24 months

  15. Duration of treatment interruptions and discontinuations.

    Duration of treatment interruptions and discontinuations.

    Measured: Up to 24 months

  16. Characterization of patient subgroups with and without 100% adherence

    Patients with matching number of planned doses and number of administered doses within 1 year (eg, previous experience with sub-cutaneous therapy)

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start23 Oct 2024
  3. Primary completion29 Nov 2028 (estimated)
  4. Study completion29 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
519 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06551519
Sponsor's protocol ID
COMB157GDE04
Acronym
FILAXOS
Status last verified
Sep 2026
First submitted
9 Aug 2024
Last updated
6 Oct 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 82 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with high serum neurofilament light (sNfL) levels (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06551519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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