A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ofatumumab
  • glatiramer acetate
  • interferon β1
  • teriflunomide
  • dimethyl fumarate (DMF)
  • diroximel fumarate (DRF)

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators