Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

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.

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 participant who is pregnant or plans to breast-feed while taking cladribine tablets, or any patient who or whose partner plans to become pregnant in Year 1 or within 6 months after the last dose in Year 2, or any participants who is unwilling or unable to use contraception per the SmPC
• Have participated or participating in an interventional study since cladribine tablet initiation, in which participant assessment and/or treatment may be dictated by a protocol
• Participants who, at the discretion of the Investigator, will not be able to provide reliable information for the study