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

Merck KGaA (EMD Serono)

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Drug: Mavenclad

Study type: Observational

Funder types: Industry

Identifiers

NCT05797740

MS700568_0213

Details and patient eligibility

About

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.

Enrollment: 367 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

367 participants in 1 patient group

Single cohort

Description:

This is a single cohort study enrolling Participants with relapsing multiple sclerosis (RMS), who are prescribed treatment with cladribine tablets in routine clinical practice following the summary of product characteristics (SmPC).

Treatment:

Drug: Mavenclad