Clinical trial NCT05797740: Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Official title: Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Relapsing Multiple Sclerosis
Mavenclad
Cladribine Tablets
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2023-04-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study enrolls participants with a confirmed diagnosis of RMS (with high disease activity) who have been prescribed, have initiated, or have completed/discontinued treatment with cladribine tablets per the decision of the treating physician.

Brief summary: 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 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

Primary outcomes:
measure: Time to Discontinuation of Treatment with Cladribine tablets
timeFrame: Up to 48 months
Secondary outcomes:
measure: Percentage of participants Receiving Each of The Possible Number of Annual Treatment Courses with Cladribine Tablets
timeFrame: Baseline, 12 months, 24 months, 36 months and 48 months
measure: Cumulative Cladribine Dose
timeFrame: Up to 48 months
measure: Number of Relapses
timeFrame: Baseline, 12 months, 24 months, 36 months and 48 months
measure: Proportion of Severe Relapses
timeFrame: Baseline, 12 months, 24 months, 36 months and 48 months
measure: Percentage of Participants Free From Relapse
timeFrame: Year 2 and Year 4
measure: Time From Onset of Relapse to Recovery
timeFrame: Up to Month 48
measure: Annualized Relapse Rate (ARR)
timeFrame: At Year 2 and Year 4
measure: Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity
timeFrame: At Year 1, Year 2, Year 3 and Year 4
measure: Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions)
timeFrame: At Year 1, Year 2, Year 3 and Year 4
measure: Timed 25-Foot Walk (T25FW) Score
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
measure: Percentage of Participants with an Increase and Decrease in Timed 25-Foot Walk (T25FW) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
measure: 9-Hole Peg Test (9HPT) Score
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
measure: Percentage of Participants with an Increase and Decrease in 9-Hole Peg Test (9HPT) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
measure: Percentage of Participants With Progressed, Improved, or Stable Disability as Assessed by Expanded Disability Status Scale (EDSS) Confirmed Over 6 Months
timeFrame: Year 1, Year 2, Year 3 and Year 4
measure: Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by T25FW Score
timeFrame: Year 1, Year 2, Year 3 and Year 4
measure: Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by 9HPT Score
timeFrame: Year 1, Year 2, Year 3 and Year 4
measure: Percentage of Participants With Minimal Evidence of Disease Activity (MEDA)
timeFrame: Year 2 and Year 4
measure: Percentage of Participants With No Evidence of Disease Activity (NEDA-3)
timeFrame: Year 2 and Year 4
measure: Multiple Sclerosis Impact Scale (MSIS-29) Physical Domain Score, Psychological Domain Score and Total Score
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
measure: EuroQol 5-Dimensions (EQ-5D-5L) Score
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
measure: Global Satisfaction, Effectiveness, Side Effects, and Convenience Domain Scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
measure: Treatment Cost of Disease-Modifying Treatment (DMTs)
timeFrame: Up to 48 months
measure: EuroQol Visual Analog Scale (EQ-VAS) Score
timeFrame: Baseline, Year 1, Year 2, Year 3 and Year 4
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: UCL Saint Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Kortrijk
country: Belgium
facility: AZ Groeninge vzw
city: Liege 1
country: Belgium
facility: CHU Sart Tilman
city: Brno
country: Czechia
facility: FN u sv. Anny Brno
city: Hradec Kralove
country: Czechia
facility: FN Hradec Králové
city: Hradec Kralove
country: Czechia
facility: NeuropsychiatrieHK
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Teplice
country: Czechia
facility: Nemocnice Teplice
city: Alexandroupoli
country: Greece
facility: University of Thrace, Medical School - Neurology Department, Alexandroupoli
city: Athens
country: Greece
facility: Aiginiteio' Hospital
city: Athens
country: Greece
facility: Attikon
city: Athens
country: Greece
facility: Evagelismos
city: Athens
country: Greece
facility: General Miliary Hospital of Athens "401"
city: Ioannina
country: Greece
facility: University of Ioannina - Neurology department
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patras
country: Greece
facility: General Hospital "Agios Andreas"
city: Patras
country: Greece
facility: University of Patras
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Athens G.Gennimatas
city: Thessaloniki
country: Greece
facility: Interbalkan Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: St Luke's Clinic
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland
city: Krakow
country: Poland
facility: Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie
city: Poznan
country: Poland
facility: Medical Academy Neurology Clinic
city: Szczecin
country: Poland
facility: Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte Hospital de Santa Maria
city: Lisbon
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos
city: Porto
country: Portugal
facility: Centro Hospitalar de São João E. P. E.
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: