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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797740
• Other study ID #: MS700568_0213
• Status: Recruiting
• Start date: August 3, 2023
• Est. completion date: August 11, 2028

Study information

• Verified date: June 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: Communication Center
• Phone: +496151725200
• Email: service[@]emdgroup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: August 11, 2028
• Est. primary completion date: August 11, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Mavenclad
This is an observational study, participants who received cladribine tablets in routine clinical practice following the SmPC will be included.

Locations

Country	Name	City	State
Belgium	UCL Saint Luc	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	AZ Groeninge vzw	Kortrijk
Belgium	CHU Sart Tilman	Liege 1
Czechia	FN u sv. Anny Brno	Brno
Czechia	FN Hradec Králové	Hradec Kralove
Czechia	NeuropsychiatrieHK	Hradec Kralove
Czechia	Fakultni nemocnice Ostrava	Ostrava
Czechia	Nemocnice Teplice	Teplice
Greece	University of Thrace, Medical School - Neurology Department, Alexandroupoli	Alexandroupoli
Greece	251 General Air Force Hospital	Athens
Greece	Aiginiteio' Hospital	Athens
Greece	Attikon	Athens
Greece	Evagelismos	Athens
Greece	General Miliary Hospital of Athens "401"	Athens
Greece	General Oncology Hospital "Agioi Anargyroi"	Athens
Greece	University of Ioannina - Neurology department	Ioannina
Greece	University Hospital of Larissa	Larissa
Greece	General Hospital "Agios Andreas"	Patras
Greece	University of Patras	Patras
Greece	AHEPA University Hospital of Thessaloniki	Thessaloniki
Greece	General Hospital of Athens G.Gennimatas	Thessaloniki
Greece	Interbalkan Hospital of Thessaloniki	Thessaloniki
Greece	Papageorgiou General Hospital Thessaloniki	Thessaloniki
Greece	St Luke's Clinic	Thessaloniki
Netherlands	Zuyderland	Sittard-Geleen
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Medical Academy Neurology Clinic	Poznan
Poland	Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie	Szczecin
Portugal	Centro Hospitalar e Universitario de Coimbra	Coimbra
Portugal	Centro Hospitalar Lisboa Norte Hospital de Santa Maria	Lisboa
Portugal	Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos	Lisbon
Portugal	Centro Hospitalar de São João E. P. E.	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

Belgium,  Czechia,  Greece,  Netherlands,  Poland,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Discontinuation of Treatment with Cladribine tablets		Up to 48 months
Secondary	Percentage of participants Receiving Each of The Possible Number of Annual Treatment Courses with Cladribine Tablets		Baseline, 12 months, 24 months, 36 months and 48 months
Secondary	Cumulative Cladribine Dose		Up to 48 months
Secondary	Number of Relapses		Baseline, 12 months, 24 months, 36 months and 48 months
Secondary	Proportion of Severe Relapses		Baseline, 12 months, 24 months, 36 months and 48 months
Secondary	Percentage of Participants Free From Relapse		Year 2 and Year 4
Secondary	Time From Onset of Relapse to Recovery		Up to Month 48
Secondary	Annualized Relapse Rate (ARR)		At Year 2 and Year 4
Secondary	Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity		At Year 1, Year 2, Year 3 and Year 4
Secondary	Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions)		At Year 1, Year 2, Year 3 and Year 4
Secondary	Timed 25-Foot Walk (T25FW) Score		Baseline, Year 1, Year 2, Year 3 and Year 4
Secondary	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		Baseline, Year 1, Year 2, Year 3 and Year 4
Secondary	9-Hole Peg Test (9HPT) Score		Baseline, Year 1, Year 2, Year 3 and Year 4
Secondary	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		Baseline, Year 1, Year 2, Year 3 and Year 4
Secondary	Percentage of Participants With Progressed, Improved, or Stable Disability as Assessed by Expanded Disability Status Scale (EDSS) Confirmed Over 6 Months		Year 1, Year 2, Year 3 and Year 4
Secondary	Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by T25FW Score		Year 1, Year 2, Year 3 and Year 4
Secondary	Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by 9HPT Score		Year 1, Year 2, Year 3 and Year 4
Secondary	Percentage of Participants With Minimal Evidence of Disease Activity (MEDA)		Year 2 and Year 4
Secondary	Percentage of Participants With No Evidence of Disease Activity (NEDA-3)		Year 2 and Year 4
Secondary	Multiple Sclerosis Impact Scale (MSIS-29) Physical Domain Score, Psychological Domain Score and Total Score		Baseline, Year 1, Year 2, Year 3 and Year 4
Secondary	EuroQol 5-Dimensions (EQ-5D-5L) Score		Baseline, Year 1, Year 2, Year 3 and Year 4
Secondary	Global Satisfaction, Effectiveness, Side Effects, and Convenience Domain Scores of Treatment Satisfaction Questionnaire for Medication (TSQM)		Baseline, Year 1, Year 2, Year 3 and Year 4
Secondary	Treatment Cost of Disease-Modifying Treatment (DMTs)		Up to 48 months
Secondary	EuroQol Visual Analog Scale (EQ-VAS) Score		Baseline, Year 1, Year 2, Year 3 and Year 4

External Links

•   Trial Awareness and Transparency website