A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis

Last Update: Mar 21, 2024

A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

ClinicalTrials.gov Identifier:

NCT05344469

Novartis Reference Number:COMB157GDE02

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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 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.

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.

Condition

Relapsing Multiple Sclerosis

Overall Status

Recruiting

Number of Participants

800

Start Date

May 10, 2022

Completion Date

Dec 31, 2026

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

glatiramer acetate

There is no treatment allocation. Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.

Other

interferon β1

There is no treatment allocation. Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.

Other

ofatumumab

There is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Male or female patients aged ≥18 years at enrollment
Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
RMS with active disease as defined by Lublin et al. (2014)
Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment

Exclusion Criteria:

Patients being treated outside of the approved label
> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7)
Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab

Study Location

Novartis Investigative Site

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Giessen,35392,Germany

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Neuruppin,16816,Germany

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Bergneustadt,51702,Germany

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Koln,50935,Germany

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Siegen,57076,Germany

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Chemnitz,09117,Germany

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Essen,45257,Germany

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Muenster,48149,Germany

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Altmark,Sachsen-Anhalt,39629,Germany

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Hannover,Lower Saxony,30161,Germany

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Rostock,18057,Germany

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Berlin,14169,Germany

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Marburg,35043,Germany

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Unterhaching,82008,Germany

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Duisburg,47138,Germany

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Gladenbach,35075,Germany

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Oer-Erkenschwick,Northrhine Westfalia,50996,Germany

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Berlin,10437,Germany

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Köln,51063,Germany

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Stadtroda,07646,Germany

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Dessau,06846,Germany

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Muenster,Northwest,48165,Germany

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Alzey,55232,Germany

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Falkensee,Brandenburg,14612,Germany

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Hannover,Lower Saxony,30449,Germany

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Ruedersdorf,15562,Germany

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Boblingen,71032,Germany

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Meerbusch,North Rhine-Westfalia,40667,Germany

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Untermeiting,Bayern,86836,Germany

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Düsseldorf,40211,Germany

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Osnabrück,49074,Germany

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Berlin,10713,Germany

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Hagen,58095,Germany

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Leipzig,04103,Germany

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Stuttgart,70174,Germany

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Dillingen,89407,Germany

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Mühlhausen,99974,Germany

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Bad Homburg,61348,Germany

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Frankfurt,60313,Germany

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Ruelzheim,76761,Germany

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Bochum,44787,Germany

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Hettingen,Baden Wuerttemberg,72513,Germany

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Mettmann,40822,Germany

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Weil der Stadt,71263,Germany

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Düsseldorf,40625,Germany

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Pforzheim,75172,Germany

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Berlin,120999,Germany

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Halle (Saale),06120,Germany

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Stuttgart,70176,Germany

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Dortmund,44135,Germany

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Luenen,44534,Germany

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München,81829,Germany

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Bamberg,Bavaria,96052,Germany

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Frankfurt,65929,Germany

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Saalouis,66740,Germany

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Bochum,44791,Germany

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Itzehoe,25524,Germany

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Wildeshausen,Lower Saxony,27793,Germany

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Erbach,64711,Germany

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Minden,32429,Germany

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Potsdam,14471,Germany

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Berlin,12163,Germany

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Hamburg,20249,Germany

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Stuttgart,70182,Germany

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Dresden,01067,Germany

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Fulda,36037,Germany

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Nagold,72202,Germany

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Bamberg,96047,Germany

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Schwaebisch,Baden-Wuerttemberg,74523,Germany

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Bonn,53111,Germany

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Jena,07740,Germany

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Wolfratshausen,82515,Germany

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Erlangen,91054,Germany

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Muelheim an der Ruhr,45468,Germany

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Altenburg,04600,Germany

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Hamburg,22179,Germany

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Regensburg,93059,Germany

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Berlin,12351,Germany

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Trier,54292,Germany

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Dresden,01307,Germany

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Mannheim,66163,Germany

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Gelsenkirchen,45894,Germany

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Neuburg an der Donau,86633,Germany

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Bayreuth,95445,Germany

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Kaiserslautern,67655,Germany

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Schwetzingen,BW,68723,Germany

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Bremen,28195,Germany

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Essen,45138,Germany

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Muenchen,81675,Germany

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Altenholz,24161,Germany

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Hannover,30625,Germany

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Remscheid,42853,Germany

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Berlin,13357,Germany

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Tuebingen,72076,Germany

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Duesseldorf,40225,Germany

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Marburg,35037,Germany

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Phone: +41613241111

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