This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult participants, male or female patients ≥ 18 years old at index date
* Participants must voluntarily give written informed consent form (ICF). Patients must read and fully understand the ICF
* Participants with confirmed diagnosis of RMS at index date, diagnosed by the treating physician according to applicable clinical practice guidelines (currently McDonald 2017 criteria), with high disease activity.
* Required historical data should be available: number of relapses in the 12 months prior to index date, DMTs taken prior to index date, date of MS diagnosis, and data of at least 1 MRI prior to index date as specified in the drug Summary of Product Characteristics (SmPC)
* Fulfillment of the indication for treatment with cladribine tablets at index date, per standard of care in accordance with the local SmPC
* Meeting 1 of the following criteria:
* Prospective participants: Having been prescribed with cladribine tablets or having taken at least one dose of cladribine tablets, with enrollment date prior to the second treatment week
* Retrospective participants: Having taken at least one dose of cladribine tablets, with enrollment date during or after the second treatment week but not more than 3 years after the first dose of cladribine tablets
Exclusion Criteria:
* Contraindications to use of cladribine tablets according to the SmPC.
* Any participant who had the first dose of cladribine tablets more than 3 years prior to enrollment
* Any parti…
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
Time to Discontinuation of Treatment with Cladribine tablets
Timeframe: Up to 48 months
Trial details
NCT IDNCT05797740
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany