A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Scler… (NCT05344469) | Clinical Trial Compass
RecruitingNot Applicable
A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
Germany800 participantsStarted 2022-05-10
Plain-language 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 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 participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who continue to receive their baseline treatment
. Signed informed consent must be obtained prior to participation,
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
. Patients being treated outside of the approved label,