No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Study type
Observational
Participants needed
800 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for people with relapsing multiple sclerosis (MS) who are starting treatment with approved therapies. Participants will fill out questionnaires and share their medical history for up to four years.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with relapsing multiple sclerosis.
I have had no more than 1 relapse in the past year.
I have had no more than 2 relapses in the past two years.
I have a disability status score between 0 and 2.5 (Cohort 1) or 0 to 3.0 (Cohort 2).
I am starting or have started an approved injectable or oral treatment within the last 14 days.
You may not be able to join if
I am being treated with a medication not approved for my condition.
It has been more than 5 years since my first MS symptom.
I have participated in any investigational trial recently.
I have had severe disability from a relapse before joining.
I have poor recovery from my first two relapses.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 durat…
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Cohort 1 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 Lub…
Cohort 1 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
Cohort 2 Inclusion Criteria:
1. Signed informed consent must be obtained prior to participation,
2. Male or female patients aged ≥18 years at enrollment,
3. Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),
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 3.0 (inclusive),
7. 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:
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
Cohort 2 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. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,
4. Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2
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