Status:
RECRUITING
A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-100 years
Brief Summary
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 w...
Detailed Description
The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable or oral DMT for RMS as routine medical ...
Eligibility Criteria
Inclusion
- Cohort 1
- 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
- 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
- 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
Key Trial Info
Start Date :
May 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2029
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05344469
Start Date
May 10 2022
End Date
May 30 2029
Last Update
March 9 2026
Active Locations (111)
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1
Novartis Investigative Site
Hettingen, Baden-Wurttemberg, Germany, 72513
2
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany, 68163
3
Novartis Investigative Site
Nagold, Baden-Wurttemberg, Germany, 72202
4
Novartis Investigative Site
Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523