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A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05344469
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Multiple Sclerosis

Additional Details

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.

Arms & Interventions

Arms

: Ofatumumab

Patients treated with ofatumumab

: Standard of Care (SoC)

Patients treated with either interferon β1 (IFN-β1) or glatiramer acetate (GA)

Interventions

Other: - ofatumumab

There is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Hettingen, Baden Wuerttemberg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hettingen, Baden Wuerttemberg, 72513

Site Contact

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