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.
Interventions
glatiramer acetate
interferon β1
ofatumumab
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
Bamberg,Bavaria,96052,Germany
Novartis Investigative Site
Recruiting
Köln,51063,Germany
Novartis Investigative Site
Recruiting
Dresden,01307,Germany
Novartis Investigative Site
Recruiting
Tuebingen,72076,Germany
Novartis Investigative Site
Recruiting
Nagold,72202,Germany
Novartis Investigative Site
Recruiting
Giessen,35392,Germany
Novartis Investigative Site
Recruiting
Bayreuth,95445,Germany
Novartis Investigative Site
Recruiting
Siegen,57076,Germany
Novartis Investigative Site
Recruiting
Bremen,28195,Germany
Novartis Investigative Site
Recruiting
Muenster,Northwest,48165,Germany
Novartis Investigative Site
Recruiting
Minden,32429,Germany
Novartis Investigative Site
Recruiting
Essen,45138,Germany
Novartis Investigative Site
Recruiting
Regensburg,93059,Germany
Novartis Investigative Site
Recruiting
Jena,07740,Germany
Novartis Investigative Site
Recruiting
Berlin,13357,Germany
Novartis Investigative Site
Recruiting
Unterhaching,82008,Germany
Novartis Investigative Site
Recruiting
Untermeiting,Bayern,86836,Germany
Novartis Investigative Site
Recruiting
Leipzig,04103,Germany
Novartis Investigative Site
Recruiting
Duesseldorf,40225,Germany
Novartis Investigative Site
Recruiting
Bergneustadt,51702,Germany
Novartis Investigative Site
Recruiting
Neuburg an der Donau,86633,Germany
Novartis Investigative Site
Recruiting
Gladenbach,35075,Germany
Novartis Investigative Site
Recruiting
Stadtroda,07646,Germany
Novartis Investigative Site
Recruiting
Chemnitz,09117,Germany
Novartis Investigative Site
Recruiting
Altenburg,04600,Germany
Novartis Investigative Site
Recruiting
Muelheim an der Ruhr,45468,Germany
Novartis Investigative Site
Recruiting
Essen,45257,Germany
Novartis Investigative Site
Recruiting
Berlin,14169,Germany
Novartis Investigative Site
Recruiting
Remscheid,42853,Germany
Novartis Investigative Site
Recruiting
Kaiserslautern,67655,Germany
Novartis Investigative Site
Recruiting
Weil der Stadt,71263,Germany
Novartis Investigative Site
Recruiting
Schwetzingen,BW,68723,Germany
Novartis Investigative Site
Recruiting
Luenen,44534,Germany
Novartis Investigative Site
Recruiting
Düsseldorf,40211,Germany
Novartis Investigative Site
Recruiting
Berlin,10437,Germany
Novartis Investigative Site
Recruiting
Neuruppin,16816,Germany
Novartis Investigative Site
Recruiting
Hagen,58095,Germany
Novartis Investigative Site
Recruiting
Dessau,06846,Germany
Novartis Investigative Site
Recruiting
Stuttgart,70174,Germany
Novartis Investigative Site
Recruiting
Altenholz,24161,Germany
Novartis Investigative Site
Recruiting
Muenchen,81675,Germany
Novartis Investigative Site
Recruiting
Frankfurt,60313,Germany
Novartis Investigative Site
Recruiting
Boblingen,71032,Germany
Novartis Investigative Site
Recruiting
Rostock,18057,Germany
Novartis Investigative Site
Recruiting
Koln,50935,Germany
Novartis Investigative Site
Recruiting
Düsseldorf,40625,Germany
Novartis Investigative Site
Recruiting
Wolfratshausen,82515,Germany
Novartis Investigative Site
Recruiting
Hannover,Lower Saxony,30161,Germany
Novartis Investigative Site
Recruiting
Mannheim,66163,Germany
Novartis Investigative Site
Recruiting
Berlin,10713,Germany
Novartis Investigative Site
Recruiting
Nuernberg,90491,Germany
Novartis Investigative Site
Recruiting
Halle (Saale),06120,Germany
Novartis Investigative Site
Recruiting
Dillingen,89407,Germany
Novartis Investigative Site
Recruiting
Stuttgart,70176,Germany
Novartis Investigative Site
Recruiting
Frankfurt,65929,Germany
Novartis Investigative Site
Recruiting
Alzey,55232,Germany
Novartis Investigative Site
Recruiting
Muenster,48149,Germany
Novartis Investigative Site
Recruiting
Bochum,44787,Germany
Novartis Investigative Site
Recruiting
Ruedersdorf,15562,Germany
Novartis Investigative Site
Recruiting
Erbach,64711,Germany
Novartis Investigative Site
Recruiting
Hannover,Lower Saxony,30449,Germany
Novartis Investigative Site
Recruiting
Marburg,35037,Germany
Novartis Investigative Site
Recruiting
Hamburg,20249,Germany
Novartis Investigative Site
Recruiting
Berlin,120999,Germany
Novartis Investigative Site
Recruiting
Osnabrück,49074,Germany
Novartis Investigative Site
Recruiting
Dortmund,44135,Germany
Novartis Investigative Site
Recruiting
Stuttgart,70182,Germany
Novartis Investigative Site
Recruiting
Hettingen,Baden Wuerttemberg,72513,Germany
Novartis Investigative Site
Recruiting
Fulda,36037,Germany
Novartis Investigative Site
Recruiting
Bad Homburg,61348,Germany
Novartis Investigative Site
Recruiting
Mühlhausen,99974,Germany
Novartis Investigative Site
Recruiting
Bochum,44791,Germany
Novartis Investigative Site
Recruiting
Ruelzheim,76761,Germany
Novartis Investigative Site
Recruiting
Marburg,35043,Germany
Novartis Investigative Site
Recruiting
Erfurt,99099,Germany
Novartis Investigative Site
Recruiting
Wildeshausen,Lower Saxony,27793,Germany
Novartis Investigative Site
Recruiting
Hamburg,22179,Germany
Novartis Investigative Site
Recruiting
Berlin,12163,Germany
Novartis Investigative Site
Recruiting
Pforzheim,75172,Germany
Novartis Investigative Site
Recruiting
Dresden,01067,Germany
Novartis Investigative Site
Recruiting
Trier,54292,Germany
Novartis Investigative Site
Recruiting
Schwaebisch,Baden-Wuerttemberg,74523,Germany
Novartis Investigative Site
Recruiting
München,81829,Germany
Novartis Investigative Site
Recruiting
Gelsenkirchen,45894,Germany
Novartis Investigative Site
Recruiting
Bamberg,96047,Germany
Novartis Investigative Site
Recruiting
Bonn,53111,Germany
Novartis Investigative Site
Recruiting
Saalouis,66740,Germany
Novartis Investigative Site
Recruiting
Mettmann,40822,Germany
Novartis Investigative Site
Recruiting
Erlangen,91054,Germany
Novartis Investigative Site
Recruiting
Meerbusch,North Rhine-Westfalia,40667,Germany
Novartis Investigative Site
Recruiting
Potsdam,14471,Germany
Novartis Investigative Site
Recruiting
Hannover,30625,Germany
Novartis Investigative Site
Recruiting
Berlin,12351,Germany
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.