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

NCT05797740

Active Not RecruitingN/A

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions: Multiple Sclerosis

Interventions: Mavenclad

Countries: Belgium, Czechia, Greece, Netherlands, Poland, Portugal

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (30)
  • Brussels, Belgium
  • Edegem, Belgium
  • Kortrijk, Belgium
  • Liège, Belgium
  • Brno, Czechia
  • Hradec Králové, Czechia
  • Hradec Králové, Czechia
  • Ostrava, Czechia
  • Teplice, Czechia
  • Alexandroupoli, Greece
  • Athens, Greece
  • Athens, Greece
  • Athens, Greece
  • Athens, Greece
  • Ioannina, Greece
  • Larissa, Greece
  • Pátrai, Greece
  • Pátrai, Greece
  • Thessaloniki, Greece
  • Thessaloniki, Greece
  • Thessaloniki, Greece
  • Thessaloniki, Greece
  • Sittard-Geleen, Netherlands
  • Krakow, Poland
  • Poznan, Poland
  • Szczecin, Poland
  • Coimbra, Portugal
  • Lisbon, Portugal
  • Lisbon, Portugal
  • Porto, Portugal