Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

February 7, 2024 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)

The main aim is to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying Drug (DMD) (Interferons, Glatiramer Acetate, Teriflunomide, (Dymethyl fumarate) [DMF]) to treatment with Cladribine tablets in routine clinical practice.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University of Thrace, Medical School - Neurology Department
      • Athens, Greece
        • Attikon University Hospital
      • Athens, Greece
        • 251 General Air Force Hospital
      • Athens, Greece
        • General Hospital of Athens "Evangelismos"
      • Athens, Greece
        • 417 NIMITS Hospital
      • Athens, Greece
        • Aeginiteion Hospital, University of Athens - A' Neurology Department
      • Athens, Greece
        • Evangelismos Hospital - Neurology Department
      • Athens, Greece
        • Genaral Hospital of Elefsina "Thriasio"
      • Larissa, Greece
        • University General Hospital of Larissa - Rheumatology Clinic
      • Patra, Greece
        • General Hospital of Patra "Agios Andreas"
      • Patras, Greece
        • University General Hospital of Patra
      • Thessaloniki, Greece
        • General Hospital of Thessaloniki "G. Papanikolaou"
      • Thessaloniki, Greece
        • AHEPA General Hospital of Thessaloniki
      • Thessaloniki, Greece
        • Interbalkan Hospital of Thessaloniki
      • Thessaloniki, Greece
        • Papageorgiou General Hospital Thessaloniki
      • Thessaloniki, Greece
        • St Luke's Hospital
  • Italy
      • Bergamo, Italy
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia
      • Cefalù, Italy
        • Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla
      • Chieti, Italy
        • Università degli Studi G. D'Annunzio
      • Cona, Italy
        • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia
      • Foggia, Italy
        • Ospedali Riuniti di Foggia - Neurology
      • Gallarate, Italy
        • Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla
      • L'Aquila, Italy
        • ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia
      • Messina, Italy
        • IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori
      • Napoli, Italy
        • Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C.
      • Novara, Italy
        • Ospedale Maggiore della carità - Novara
      • Orbassano, Italy
        • Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia
      • Palermo, Italy
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze
      • Perugia, Italy
        • Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia - UO Neurologia
      • Reggio Calabria, Italy
        • Grande Ospedale Metropolitano "Bianchi Melacrino Morelli - Centro Regionale Epilessia
      • Roma, Italy
        • Azienda Ospedaliera San Filippo Neri - Neurologia
      • Roma, Italy
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Dip. di Neurologia e Psichiatria (servizio EMG)
      • Salerno, Italy
        • A. O. U. San Giovanni Di Dio e Ruggi D'Aragona - Struttura Complessa di Oculistica
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - D.U.Neurologia
  • Norway
      • Drammen, Norway
        • Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud
      • Namsos, Norway
        • Sykehuset Namsos
      • Oslo, Norway
        • Oslo universitetssykehus HF - Ullevål
  • Poland
      • Bialystok, Poland
        • Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Neurology
      • Krakow, Poland
        • Szpital Specjalistyczny im. L.Rydygiera w Krakowie - Neurology Department
      • Krakow, Poland
        • Szpital Uniwersytecki w Krakowie - Uniwersytet Jagiellonski Collegium Medicum
      • Poznan, Poland
        • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
      • Warszawa, Poland
        • Wojskowy Instytut Medyczny - Klinika Neurologiczna
      • Zory, Poland
        • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
  • Portugal
      • Lisboa, Portugal
        • Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia
      • Matosinhos, Portugal
        • Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia
      • Porto, Portugal
        • Centro Hospitalar de São João, E.P.E. - Serviço de Neurologia
      • Pragal, Portugal
        • Hospital Garcia de Orta, EPE - Serviço de Neurologia
      • Setúbal, Portugal
        • Centro Hospitalar de Setubal, EPE - Hospital São Bernardo
      • Viana De Castelo, Portugal
        • Unidade Local de Saúde do Alto Minho, EPE - Serviço de Neurologia
  • Switzerland
      • Bern, Switzerland
        • Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
      • Lausanne, Switzerland
        • (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
      • Lugano, Switzerland
        • Ospedale Regionale di Lugano - Neurologia
      • Sion, Switzerland
        • Hôpital Régional Sion-Hérens-Conthey - Neurologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with a confirmed diagnosis of Highly Active Relapsing-Remitting Multiple Sclerosis (RRMS).

Description

Inclusion Criteria:

  • Participants with confirmed diagnosis of RRMS diagnosed by the treating physician according to applicable clinical practice guidelines -(currently McDonald 2017 criteria), with high disease activity
  • Participants should have been treated with the same first-line DMD (Interferons, Glatiramer Acetate, Teriflunomide, DMF) and at a stable dose for at least one year prior to switch to Cladribine tablets and should have been prescribed Cladribine tablets, according to the decision of the treating physician, prior to enrollment in the study. Any washout period and/or washout methods required before switching (such as elimination of Teriflunomide) must have been conducted, according to the decision of the treating physician
  • Required history data should be available: Multiple Sclerosis (MS) data for the 12-months pre-baseline period (annualized relapse rate); MS Medication History (prior DMDs)
  • Fulfilment of the criteria for treatment with Cladribine tablets per standard of care in accordance with the local Summary of Product Characteristics (SmPC)

Exclusion Criteria:

  • Contraindications to use of cladribine tablets according to the SmPC
  • Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study
  • Participants that have received Cladribine in the past
  • Concurrent participation in an investigational study in which participant assessment and/or treatment may be dictated by a protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cladribine
Drug: Cladribine
No intervention will be administered as a part of this study. Participants who had switched from first-line DMD treatments to treatment with cladribine tablets in routine clinical practice will be assessed for 2 years in this study.
Other Names:
  • MAVENCLAD ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period Before the End of Study Follow-Up
Time Frame: 12-months pre-baseline up to Year 2 post-baseline
12-months pre-baseline up to Year 2 post-baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period After the Start of Cladribine
Time Frame: 12-months pre-baseline up to Year 1 post-baseline
12-months pre-baseline up to Year 1 post-baseline
Percentage of Participants with 6-Month Disability Progression in Expanded Disability Status Scale (EDSS)
Time Frame: Up to 2 years
Up to 2 years
Percentage of Participants with 6-Month Disability Progression in Timed 25 Foot Walk (T25FW)
Time Frame: Up to 2 years
Up to 2 years
Percentage of Participants with 6-Month Disability Progression in 9-Hole-Peg Test (9HPT)
Time Frame: Up to 2 years
Up to 2 years
Percentage of Participants with 6-Month Disability Improvement in Expanded Disability Status Scale (EDSS)
Time Frame: Up to 2 years
Up to 2 years
Percentage of Participants with 6-Month Disability Improvement in Timed 25 Foot Walk (T25FW)
Time Frame: Up to 2 years
Up to 2 years
Percentage of Participants with 6-Month Disability Improvement in 9-Hole-Peg Test (9HPT)
Time Frame: Up to 2 years
Up to 2 years
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 2 years
Up to 2 years
Quality of Life Assessed by Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: Baseline, Months 12 and 24
Baseline, Months 12 and 24
Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale
Time Frame: Months 6, 12, 18 and 24
Months 6, 12, 18 and 24
Pharmacoeconomic Data Assessed by Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Questionnaire
Time Frame: Baseline, Months 12 and 24
Baseline, Months 12 and 24
Percentage of Participants With Treatment Adherence
Time Frame: Up to Month 24
Up to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Merck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Estimated)

July 29, 2024

Study Completion (Estimated)

July 29, 2024

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS700568_0070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Cladribine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe