A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
Recruiting · NCT05344469 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
dimethyl fumarate (DMF)diroximel fumarate (DRF)glatiramer acetateinterferon β1ofatumumabteriflunomide
What this trial is about
This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
- Cohort 2 Inclusion Criteria:
- Signed informed consent must be obtained prior to participation,
- Male or female patients aged ≥18 years at enrollment,
- Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),
- 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 3.0 (inclusive),
- Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment:
- Ofatumumab: only naïve patients or patients previously treated with max. one DMT other than ofatumumab
- IFN-β1, GA, teriflunomide, DMF or DRF: only naïve patients
- Cohort 1
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
- Cohort 2 Exclusion Criteria:
- Patients being treated outside of the approved label,
- \>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,
- Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2
Where it is running
60 locations listed.
- Novartis Investigative Site - Aalen, Germany
- Novartis Investigative Site - Altenholz, Germany
- Novartis Investigative Site - Alzey, Germany
- Novartis Investigative Site - Bamberg, Germany
- Novartis Investigative Site - Bayreuth, Germany
- Novartis Investigative Site - Bergneustadt, Germany
- Novartis Investigative Site - Bergneustadt, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Bochum, Germany
- Novartis Investigative Site - Bochum, Germany
- Novartis Investigative Site - Bogen, Germany
- Novartis Investigative Site - Bonn, Germany
- Novartis Investigative Site - Braunschweig, Germany
- Novartis Investigative Site - Bremen, Germany
- Novartis Investigative Site - Böblingen, Germany
- Novartis Investigative Site - Chemnitz, Germany
- Novartis Investigative Site - Coburg, Germany
- Novartis Investigative Site - Crailsheim, Germany
- Novartis Investigative Site - Dessau, Germany
- Novartis Investigative Site - Dillingen Saar, Germany
- Novartis Investigative Site - Dresden, Germany
- Novartis Investigative Site - Dresden, Germany
- Novartis Investigative Site - Duisburg, Germany
- Novartis Investigative Site - Duisburg, Germany
- Novartis Investigative Site - Düsseldorf, Germany
- Novartis Investigative Site - Düsseldorf, Germany
- Novartis Investigative Site - Düsseldorf, Germany
- Novartis Investigative Site - Eisleben Lutherstadt, Germany
- Novartis Investigative Site - Eltville, Germany
- Novartis Investigative Site - Erbach im Odenwald, Germany
- Novartis Investigative Site - Erfurt, Germany
- Novartis Investigative Site - Erfurt, Germany
- Novartis Investigative Site - Erlangen, Germany
- Novartis Investigative Site - Essen, Germany
- Novartis Investigative Site - Essen, Germany
- Novartis Investigative Site - Fulda, Germany
- Novartis Investigative Site - Fulda, Germany
- Novartis Investigative Site - Giessen, Germany
- Novartis Investigative Site - Gladenbach, Germany
- Novartis Investigative Site - Hagen, Germany
- Novartis Investigative Site - Hamburg, Germany
- Novartis Investigative Site - Hamburg, Germany
- Novartis Investigative Site - Hanover, Germany
- Novartis Investigative Site - Höxter, Germany
- Novartis Investigative Site - Itzehoe, Germany
- Novartis Investigative Site - Kaiserslautern, Germany
- Novartis Investigative Site - Karlsruhe, Germany
- Novartis Investigative Site - Karlsruhe, Germany
- Novartis Investigative Site - Lünen, Germany
- Novartis Investigative Site - Magdeburg, Germany
- Novartis Investigative Site - Marburg, Germany
Showing 60 of 141 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →