Last Update: May 13, 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
See if you Pre-qualify
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.

Relapsing Multiple Sclerosis
Recruiting
800
May 10, 2022
Dec 31, 2026
All
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:

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 two
years 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 injectable
DMT for MS as routine medical treatment

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 (except
within the past 14 days with an approved injectable DMT for MS as routine medical
treatment; see Inclusion criteria #7)

4. 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

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

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

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

Novartis Investigative Site

Recruiting

Nuernberg,90491,Germany

Novartis Investigative Site

Recruiting

Frankfurt,65929,Germany

Novartis Investigative Site

Recruiting

Alzey,55232,Germany

Novartis Investigative Site

Recruiting

Bochum,44787,Germany

Novartis Investigative Site

Recruiting

Stuttgart,70176,Germany

Novartis Investigative Site

Recruiting

Muenster,48149,Germany

Novartis Investigative Site

Recruiting

Erbach,64711,Germany

Novartis Investigative Site

Recruiting

Hannover,Lower Saxony,30449,Germany

Novartis Investigative Site

Recruiting

Ruedersdorf,15562,Germany

Novartis Investigative Site

Recruiting

Hamburg,20249,Germany

Novartis Investigative Site

Recruiting

Berlin,120999,Germany

Novartis Investigative Site

Recruiting

Hettingen,Baden Wuerttemberg,72513,Germany

Novartis Investigative Site

Recruiting

Marburg,35037,Germany

Novartis Investigative Site

Recruiting

Dortmund,44135,Germany

Novartis Investigative Site

Recruiting

Osnabrück,49074,Germany

Novartis Investigative Site

Recruiting

Fulda,36037,Germany

Novartis Investigative Site

Recruiting

Bad Homburg,61348,Germany

Novartis Investigative Site

Recruiting

Stuttgart,70182,Germany

Novartis Investigative Site

Recruiting

Bochum,44791,Germany

Novartis Investigative Site

Recruiting

Wildeshausen,Lower Saxony,27793,Germany

Novartis Investigative Site

Recruiting

Mühlhausen,99974,Germany

Novartis Investigative Site

Recruiting

Erfurt,99099,Germany

Novartis Investigative Site

Recruiting

Ruelzheim,76761,Germany

Novartis Investigative Site

Recruiting

Hamburg,22179,Germany

Novartis Investigative Site

Recruiting

Berlin,12163,Germany

Novartis Investigative Site

Recruiting

Schwaebisch,Baden-Wuerttemberg,74523,Germany

Novartis Investigative Site

Recruiting

Marburg,35043,Germany

Novartis Investigative Site

Recruiting

Dresden,01067,Germany

Novartis Investigative Site

Recruiting

Bamberg,96047,Germany

Novartis Investigative Site

Recruiting

Pforzheim,75172,Germany

Novartis Investigative Site

Recruiting

Gelsenkirchen,45894,Germany

Novartis Investigative Site

Recruiting

Trier,54292,Germany

Novartis Investigative Site

Recruiting

Bonn,53111,Germany

Novartis Investigative Site

Recruiting

Meerbusch,North Rhine-Westfalia,40667,Germany

Novartis Investigative Site

Recruiting

München,81829,Germany

Novartis Investigative Site

Recruiting

Erlangen,91054,Germany

Novartis Investigative Site

Recruiting

Berlin,12351,Germany

Novartis Investigative Site

Recruiting

Saalouis,66740,Germany

Novartis Investigative Site

Recruiting

Hannover,30625,Germany

Novartis Investigative Site

Recruiting

Bamberg,Bavaria,96052,Germany

Novartis Investigative Site

Recruiting

Mettmann,40822,Germany

Novartis Investigative Site

Recruiting

Dresden,01307,Germany

Novartis Investigative Site

Recruiting

Bayreuth,95445,Germany

Novartis Investigative Site

Recruiting

Potsdam,14471,Germany

Novartis Investigative Site

Recruiting

Giessen,35392,Germany

Novartis Investigative Site

Recruiting

Bremen,28195,Germany

Novartis Investigative Site

Recruiting

Tuebingen,72076,Germany

Novartis Investigative Site

Recruiting

Köln,51063,Germany

Novartis Investigative Site

Recruiting

Muenster,Northwest,48165,Germany

Novartis Investigative Site

Recruiting

Nagold,72202,Germany

Novartis Investigative Site

Recruiting

Essen,45138,Germany

Novartis Investigative Site

Recruiting

Berlin,13357,Germany

Novartis Investigative Site

Recruiting

Siegen,57076,Germany

Novartis Investigative Site

Recruiting

Jena,07740,Germany

Novartis Investigative Site

Recruiting

Duesseldorf,40225,Germany

Novartis Investigative Site

Recruiting

Untermeiting,Bayern,86836,Germany

Novartis Investigative Site

Recruiting

Minden,32429,Germany

Novartis Investigative Site

Recruiting

Bergneustadt,51702,Germany

Novartis Investigative Site

Recruiting

Regensburg,93059,Germany

Novartis Investigative Site

Recruiting

Gladenbach,35075,Germany

Novartis Investigative Site

Recruiting

Chemnitz,09117,Germany

Novartis Investigative Site

Recruiting

Unterhaching,82008,Germany

Novartis Investigative Site

Recruiting

Leipzig,04103,Germany

Novartis Investigative Site

Recruiting

Essen,45257,Germany

Novartis Investigative Site

Recruiting

Altenburg,04600,Germany

Novartis Investigative Site

Recruiting

Neuburg an der Donau,86633,Germany

Novartis Investigative Site

Recruiting

Berlin,14169,Germany

Novartis Investigative Site

Recruiting

Stadtroda,07646,Germany

Novartis Investigative Site

Recruiting

Kaiserslautern,67655,Germany

Novartis Investigative Site

Recruiting

Düsseldorf,40211,Germany

Novartis Investigative Site

Recruiting

Schwetzingen,BW,68723,Germany

Novartis Investigative Site

Recruiting

Muelheim an der Ruhr,45468,Germany

Novartis Investigative Site

Recruiting

Hagen,58095,Germany

Novartis Investigative Site

Recruiting

Berlin,10437,Germany

Novartis Investigative Site

Recruiting

Remscheid,42853,Germany

Novartis Investigative Site

Recruiting

Luenen,44534,Germany

Novartis Investigative Site

Recruiting

Dessau,06846,Germany

Novartis Investigative Site

Recruiting

Weil der Stadt,71263,Germany

Novartis Investigative Site

Recruiting

Frankfurt,60313,Germany

Novartis Investigative Site

Recruiting

Altenholz,24161,Germany

Novartis Investigative Site

Recruiting

Neuruppin,16816,Germany

Novartis Investigative Site

Recruiting

Koln,50935,Germany

Novartis Investigative Site

Recruiting

Boblingen,71032,Germany

Novartis Investigative Site

Recruiting

Stuttgart,70174,Germany

Novartis Investigative Site

Recruiting

Muenchen,81675,Germany

Novartis Investigative Site

Recruiting

Düsseldorf,40625,Germany

Novartis Investigative Site

Recruiting

Hannover,Lower Saxony,30161,Germany

Novartis Investigative Site

Recruiting

Halle (Saale),06120,Germany

Novartis Investigative Site

Recruiting

Berlin,10713,Germany

Novartis Investigative Site

Recruiting

Rostock,18057,Germany

Novartis Investigative Site

Recruiting

Mannheim,66163,Germany

Novartis Investigative Site

Recruiting

Dillingen,89407,Germany

Novartis Investigative Site

Recruiting

Wolfratshausen,82515,Germany

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111