A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

interferon β1

ofatumumab

glatiramer acetate

Clinical Study ID

NCT05344469
COMB157GDE02
  • Ages 18-100
  • All Genders

Study Summary

This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable Disease-modifying Therapy (DMT) for Relapsing Multiple Sclerosis in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to approx. two years of treatment. Additionally, medical history of participants will be collected including disease duration, EDSS, MRI parameters and relapses.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study

  2. Male or female patients aged ≥18 years at enrollment

  3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)

  4. RMS with active disease as defined by Lublin et al. (2014)

  5. Max. 1 relapse during the previous year and max. 2 relapses during the previous twoyears prior to enrollment

  6. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)

  7. Planned initiation or initiation within the past 14 days with an approved injectableDMT for MS as routine medical treatment

Exclusion

Exclusion Criteria:

  1. Patients being treated outside of the approved label

  2. > 5 years since first symptom(s) (leading to MS diagnosis) at enrollment

  3. Previous therapy with any DMT for the treatment of MS prior to enrollment (exceptwithin the past 14 days with an approved injectable DMT for MS as routine medicaltreatment; see Inclusion criteria #7)

  4. Relapse prior to enrollment which has led to a severe deficit relevant to everydaylife upon discretion of the investigator after exhaustion of the relapse therapy

  5. Poor recovery from the first two relapses prior to enrollment upon discretion of theinvestigator

  6. EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment

  7. Simultaneous participation in any investigational trial or simultaneousparticipation in another Novartis-sponsored non-interventional study with Ofatumumab

Study Design

Total Participants: 564
Treatment Group(s): 3
Primary Treatment: interferon β1
Phase:
Study Start date:
May 10, 2022
Estimated Completion Date:
December 31, 2026

Study Description

The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable DMT for RMS as routine medical treatment. This decision must have been made prior to enrollment in this study.

The prospective observational period per patient will be up to approx. two years from the time of consent (2 years +2 months visit window). The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.

Connect with a study center

  • Novartis Investigative Site

    Schwetzingen, BW 68723
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hettingen, Baden Wuerttemberg 72513
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schwaebisch, Baden Wuerttemberg 74523
    Germany

    Site Not Available

  • Novartis Investigative Site

    Munich, Bavaria 81241
    Germany

    Site Not Available

  • Novartis Investigative Site

    Untermeiting, Bayern 86836
    Germany

    Site Not Available

  • Novartis Investigative Site

    Falkensee, Brandenburg 14612
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Homburg, Hesse 61348
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, Lower Saxony 30449
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wildeshausen, Lower Saxony 27793
    Germany

    Site Not Available

  • Novartis Investigative Site

    Meerbusch, North Rhine-Westfalia 40667
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oer-Erkenschwick, Northrhine Westfalia 50996
    Germany

    Site Not Available

  • Novartis Investigative Site

    Altmark, Sachsen-Anhalt 39629
    Germany

    Site Not Available

  • Novartis Investigative Site

    Altenburg, 04600
    Germany

    Site Not Available

  • Novartis Investigative Site

    Altenholz, 24161
    Germany

    Site Not Available

  • Novartis Investigative Site

    Alzey, 55232
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bamberg, 96047
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bayreuth, 95445
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bergneustadt, 51702
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 10437
    Germany

    Site Not Available

  • Novartis Investigative Site

    Boblingen, 71032
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44787
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bonn, 53111
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bremen, 28195
    Germany

    Site Not Available

  • Novartis Investigative Site

    Chemnitz, 09117
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dessau, 06846
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dillingen, 89407
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dortmund, 44135
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Duesseldorf, 40625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Duisburg, 47138
    Germany

    Site Not Available

  • Novartis Investigative Site

    Düsseldorf, 40625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erbach, 64711
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erfurt, 99099
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45257
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60313
    Germany

    Site Not Available

  • Novartis Investigative Site

    Fulda, 36037
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gelsenkirchen, 45894
    Germany

    Site Not Available

  • Novartis Investigative Site

    Giessen, 35392
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gladenbach, 35075
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hagen, 58095
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle (Saale), 06120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22179
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ingelheim, 55218
    Germany

    Site Not Available

  • Novartis Investigative Site

    Itzehoe, 25524
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena, 07740
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kaiserslautern, 67655
    Germany

    Site Not Available

  • Novartis Investigative Site

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koln, 50935
    Germany

    Site Not Available

  • Novartis Investigative Site

    Köln, 51063
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Luenen, 44534
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mannheim, 66163
    Germany

    Site Not Available

  • Novartis Investigative Site

    Marburg, 35039
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mettmann, 40822
    Germany

    Site Not Available

  • Novartis Investigative Site

    Minden, 32429
    Germany

    Site Not Available

  • Novartis Investigative Site

    Montabaur, 56410
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muehlhausen, 99974
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muelheim an der Ruhr, 45468
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81675
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Munchen, 81829
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mühlhausen, 99974
    Germany

    Site Not Available

  • Novartis Investigative Site

    München, 81829
    Germany

    Site Not Available

  • Novartis Investigative Site

    Nagold, 72202
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuburg an der Donau, 86633
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuruppin, 16816
    Germany

    Site Not Available

  • Novartis Investigative Site

    Nuernberg, 90491
    Germany

    Site Not Available

  • Novartis Investigative Site

    Osnabrueck, 49074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Osnabrück, 49074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Pforzheim, 75172
    Germany

    Site Not Available

  • Novartis Investigative Site

    Potsdam, 14471
    Germany

    Site Not Available

  • Novartis Investigative Site

    Regensburg, 93059
    Germany

    Site Not Available

  • Novartis Investigative Site

    Remscheid, 42853
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rostock, 18057
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ruedersdorf, 15562
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ruelzheim, 76761
    Germany

    Site Not Available

  • Novartis Investigative Site

    Saalouis, 66740
    Germany

    Site Not Available

  • Novartis Investigative Site

    Siegen, 57076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stadtroda, 07646
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stuttgart, 70182
    Germany

    Site Not Available

  • Novartis Investigative Site

    Trier, 54292
    Germany

    Site Not Available

  • Novartis Investigative Site

    Tuebingen, 72076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Unterhaching, 82008
    Germany

    Site Not Available

  • Novartis Investigative Site

    Weil der Stadt, 71263
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wolfratshausen, 82515
    Germany

    Site Not Available

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