NCT04934800Completed
Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)
Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)
Source: ClinicalTrials.gov · Last updated 24 Jun 2025
Brief summary (registry, in English)
The main aim was 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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 256 (actual)
- First submitted
- 17 Jun 2021
- Start date
- 10 Dec 2019
- Primary completion date
- 20 May 2024
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Diseases
- Multiple sclerosis
- NCT number
- NCT04934800
What you commit to
- Study type: Observational
- Participants enrolled: 256
- From 10 Dec 2019 to the primary completion date, 20 May 2024
- 61 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study
Other
- Contraindications to use of cladribine tablets according to the SmPC
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KH der Barmherzige Brüder Eisenstadt - Neurology Coordinator of this site? Confirm its status | Eisenstadt | Austria | Unknown status |
| Dr. Reinhard Krendl-Head Coordinator of this site? Confirm its status | Sankt Veit an der Glan | Austria | Unknown status |
| Klinik Florisdorf Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Luzerner Kantonsspital - Zentrum fuer Neurologie und Neurorehabilitation Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Ospedale Regionale di Lugano - Neurologia Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Hôpital Régional Sion-Hérens-Conthey - Neurologie Coordinator of this site? Confirm its status | Sion | Switzerland | Unknown status |
| University of Thrace, Medical School - Neurology Department Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Unknown status |
| Aeginiteion Hospital, University of Athens - A' Neurology Department Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Hospital of Athens "Evangelismos" Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| 417 NIMITS Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| 251 General Air Force Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Attikon University Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Genaral Hospital of Elefsina "Thriasio" Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Evangelismos Hospital - Neurology Department Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University of Ioannina - Neurology Department, Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Unknown status |
| University General Hospital of Larissa - Rheumatology Clinic Coordinator of this site? Confirm its status | Larissa | Greece | Unknown status |
| Iatriko Palaioy Faliroy, Medical Center - Neurology Department Coordinator of this site? Confirm its status | Palaió Fáliro | Greece | Unknown status |
| University General Hospital of Patra Coordinator of this site? Confirm its status | Pátrai | Greece | Unknown status |
| General Hospital of Patra Agios Andreas Coordinator of this site? Confirm its status | Pátrai | Greece | Unknown status |
| AHEPA General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Interbalkan Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| General Hospital of Thessaloniki "G. Papanikolaou" Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Papageorgiou General Hospital Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| St. Luke's Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla Coordinator of this site? Confirm its status | Cefalù | Italy | Unknown status |
| Università degli Studi G. D'Annunzio Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia Coordinator of this site? Confirm its status | Cona | Italy | Unknown status |
| Ospedali Riuniti di Foggia - Neurology Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla Coordinator of this site? Confirm its status | Gallarate | Italy | Unknown status |
| ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia Coordinator of this site? Confirm its status | L’Aquila | Italy | Unknown status |
| Ospedale San Luca - S.C.Oncologia Coordinator of this site? Confirm its status | Lucca | Italy | Unknown status |
| IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C. Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale Maggiore della carità - Novara Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia - UO Neurologia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Grande Ospedale Metropolitano "Bianchi Melacrino Morelli - Centro Regionale Epilessia Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Azienda Ospedaliera San Filippo Neri - Neurologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Dip. di Neurologia e Psichiatria (servizio EMG) Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A. O. U. San Giovanni Di Dio e Ruggi D'Aragona - Struttura Complessa di Oculistica Coordinator of this site? Confirm its status | Salerno | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - D.U.Neurologia Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud Coordinator of this site? Confirm its status | Drammen | Norway | Unknown status |
| Sykehuset Namsos Coordinator of this site? Confirm its status | Namsos | Norway | Unknown status |
| Oslo universitetssykehus HF, Ullevål Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Neurology Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Szpital Specjalistyczny im. L.Rydygiera w Krakowie - Neurology Department Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Szpital Uniwersytecki w Krakowie - Uniwersytet Jagiellonski Collegium Medicum Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Pomorski Uniwersytet Medyczny - Klinika Neurologii Coordinator of this site? Confirm its status | Szczecin | Poland | Unknown status |
| Wojskowy Instytut Medyczny - Klinika Neurologiczna Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku Coordinator of this site? Confirm its status | Żory | Poland | Unknown status |
| Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia Coordinator of this site? Confirm its status | Matosinhos Municipality | Portugal | Unknown status |
| Centro Hospitalar de São João, E.P.E. - Serviço de Neurologia Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Hospital Garcia de Orta, EPE - Serviço de Neurologia Coordinator of this site? Confirm its status | Pragal | Portugal | Unknown status |
| Centro Hospitalar de Setubal, EPE - Hospital São Bernardo Coordinator of this site? Confirm its status | Setúbal | Portugal | Unknown status |
| Unidade Local de Saúde do Alto Minho, EPE - Serviço de Neurologia Coordinator of this site? Confirm its status | Viana de Castelo | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.