Multiple SclerosisPhase 4NCT03369665
Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 92 sites in 18 countries.
Trial summary
The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mavenclad®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 92 sitesin 18 countries
- Study dates
- 20 Jun 2018to 12 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Highly active RMS as defined by:
- One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs).
- Two or more relapses in the previous year, whether on DMD treatment or not.
- Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.
- Other protocol defined inclusion criteria could apply.
Who cannot join
- Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
- Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
- Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
- History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
- Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
- Active malignancy.
- Other protocol defined exclusion criteria could apply.
Trial locations and contacts
92 sites in 18 countries.
92 sites in 18 countries
France13 sites
Centre hospitalier de la Côte Basque - Saint Léon
Bayonne, 64100
Hopital Pellegrin
Bordeaux, 33076
University Hospital of Caen
Caen, 14033
CHRU de Lille
Lille, 59037
Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
Lomme
CHU de Nantes
Nantes, 44093
Centre Hospitalier de Gonesse
Paris, 75013
Hôpital de la Pitié-Salpétrière
Paris, 75013
CHU de Poissy
Poissy, 78303
CHU Hopital Gabriel Montpied
Puy-de-Dome, 63003
Centre Universitaire de Rouen
Rouen, 76031
Hopital Pierre-Paul Riquet - Neurologie
Toulouse, 31059
CHU Tours - Hôpital Bretonneau
Tours, 37044
Italy13 sites
A.O.U. Ospedali Riuniti Umberto I
Ancona
Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
Cagliari, 09126
Policlinico di Catania
Catania, 95125
Ospedale San Raffaele Giglio
Cefalù, 90015
Ospedale San Raffaele, IRCCS
Milan, 20127
Instituto Nazionale Neurologico "Carlo Besta"
Milan, 20133
A.O. Universitaria Federico II
Naples, 80131
Seconda Univesità degli Studi di Napoli, AOU
Naples
Villa Sofia Hospital
Palermo, 90146
Azienda Ospedaliera S. Camillo Forlanini (8025)
Roma, 00152
Azienda Ospedaliera Sant'Andrea Università La Sapienza
Roma, 00189
Neurological Center Of Latium
Roma, 00189
Policlinico Tor Vergata
Roma
Spain10 sites
C.A.U. de León - H. de León
León, 24071
Hospital Arnau de Vilanova
Lleida, 25198
Hospital General Universitario Gregorio Marañón (5030)
Madrid, 28007
H. U. Quirónsalud Madrid
Madrid, 28040
Hospital Universitario de Getafe
Madrid, 28905
Hospital Virgen de la Arrixaca
Murcia, 30120
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, 08970
Hospital Universitario Nuestra Senora de la Candelaria (4776)
Santa Cruz de Tenerfie, 38010
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Seville, 41013
Czechia8 sites
FN u sv. Anny Brno
Brno, 65691
FN Hradec Kralove
Choceň, 56501
Nemocnice Jihlava, p.o.
Jihlava, 586 33
Fakultni nemocnice Olomouc
Olomouc, 779 00
Fakultni nemocnice Ostrava (11573)
Ostrava, 70852
Faculty Hospital Kralovske Vinohrad
Prague, 100 34
Vseobecna fakultni nemocnice v Praze (11163)
Prague, 128 08
Nemocnice Teplice
Teplice, 415 29
Poland7 sites
COPERNICUS Podmiot Leczn. Sp z o.o.
Gdansk, 80-803
M.A. - LEK A.M.Maciejowscy SC.
Katowice, 40-571
Centrum Neurologii K. Selmaj
Lodz, 90-153
Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
Lodz, 90-153
Centrum Medyczne Medyk
Lublin, 20-954
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
Lublin, 20-954
Instytut Psychiatrii i Neurologii
Warsaw, 02-957
Hungary6 sites
Semmelweis Egyetem AOK
Budapest, 1083
Uzsoki Utcai Korhaz
Budapest, 1145
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest, 1204
University of Debrecen
Debrecen, 4032
VALEOMED Kft
Esztergom, 2500
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyíregyháza, 4403
United Kingdom5 sites
Institute of Neurological Sciences
Glasgow, G51 4TF
Institute of Neurological Sciences
Glasgow
GM LCRN - Great Manchester Local Clinical Research Network
Manchester, M13 9WL
The Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
Morriston Hospital (4232)
Swansea West Glamorgan, SA6 6NL
Denmark4 sites
Aalborg Hospital
Aalborg, 9100
Glostrup University Hospital
Glostrup Municipality, DK-2600
Odense Univeristy Hospital
Odense
Matthias Kant
Sønderborg, 6400
Finland4 sites
Helsinki University Central Hospital
Helsinki, 290
Helsinki University Central Hospital
Helsinki
Terveystalo Mikkeli
Mikkeli, 50100
Neo Research, Neuro NEO Oy
Turku
Slovakia4 sites
Univerzitna nemocnica Bratislava
Bratislava, 813 69
Univerzitna nemocnica Martin
Martin, 036 01
Fakultna nemocnica Nitra
Nitra, 950 01
Fakultna nemocnica Trnava
Trnava, 917 75
Austria3 sites
Kepler Universitätsklinikum
Linz, 4021
Paracelsus Medical University Salzburg
Salzburg
Eva Maida
Vienna
Belgium3 sites
Cliniques Univ. St.-Luc
Brussels, 1200
UZ Antwerpen
Edegem, 2650
Clinique Saint Pierre
Ottignies, 1340
Greece3 sites
Hos. Errikos Dynan
Athens, 11526
401 Army Hospital
Athens, 11527
Athens Medical Centre
Athens, 11527
Lithuania3 sites
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, 50161
Klaipedos Ligonine
Kaunas, 50161
Vilnius University Hospital Santariskiu Clinics
Vilnius, 8661
Portugal2 sites
Hospital de Braga
Braga, 4710-243
Centro Hospitalar do Porto E.P.E. Hospital de Santo António
Porto, 4099-001
Sweden2 sites
Karlstad Hospital (8232)
Karlstad, 651 86
Motala Hospital (11119)
Motala, 59185
About this study
Official title: A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)
The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).
- Conditions
- Multiple Sclerosis
- Being tested
- Mavenclad®
- Keywords
- Multiple sclerosis, Mavenclad®, Cladribine, Health-related Quality of Life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mavenclad®Drug
Also called Cladribine
Participants with Relapsing Multiple Sclerosis (RMS) received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consisted of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year.
| Study group | Role | What they receive |
|---|---|---|
| Mavenclad® | Experimental | Not described Receives: Drug: Mavenclad® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Physical Health Composite Summary and Mental Health Composite Summary Scores at Month 24
The MSQOL-54 was a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 sub-scales along with two summary scores, and two additional single-item measures. Sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The two summary scores physical health and mental health are derived from a weighted combination of scale scores. Each composite summary score has a range from 0-100 where higher scores indicate better QOL. A positive change from baseline indicates improvement.
Measured: Baseline, Month 24
Secondary outcomes (1)
Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6
TSQM version 1.4 was a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.
Measured: At Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start20 Jun 2018
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369665
- Sponsor's protocol ID
- MS700568_0021
- Other IDs
- 2017-002632-17, 2017
- Status last verified
- Nov 2022
- First submitted
- 6 Dec 2017
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Publications
Brochet B, Langdon D, Havrdova EK, Lechner-Scott J, Montalban X, Patti F, Piehl F, Solari A, Hupperts R, Alexandri N, Lehn A, Smyk A, Selmaj K; CLARIFY-MS Investigators. Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study. Neurol Ther. 2026 Aug;15(4):1491-1507. doi: 10.1007/s40120-026-00897-0. Epub 2026 Mar 10.
PubMed 41806309Brochet B, Solari A, Lechner-Scott J, Piehl F, Langdon D, Hupperts R, Selmaj K, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, Montalban X, Kubala Havrdova E. Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study. Mult Scler. 2023 Dec;29(14):1808-1818. doi: 10.1177/13524585231205962. Epub 2023 Nov 18.
PubMed 37978852
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)
- ClinicalTrials.gov ID
- NCT03369665
- Acronym / sponsor ID
- MS700568_0021
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Mavenclad®, Cladribine, Health-related Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mavenclad® | Experimental | Drug: Mavenclad® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Highly active RMS as defined by:
- One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs).
- Two or more relapses in the previous year, whether on DMD treatment or not.
- Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.
- Other protocol defined inclusion criteria could apply.
Key exclusion criteria (7 listed)
- Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
- Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
- Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
- History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
- Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mavenclad®Also: CladribineParticipants with Relapsing Multiple Sclerosis (RMS) received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consisted of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year. | Drug | Mavenclad® |
Primary outcome
Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Physical Health Composite Summary and Mental Health Composite Summary Scores at Month 24
Time frame: Baseline, Month 24
The MSQOL-54 was a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 sub-scales along with two summary scores, and two additional single-item measures. Sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The two summary scores physical health and mental health are derived from a weighted combination of scale scores. Each composite summary score has a range from 0-100 where higher scores indicate better QOL. A positive change from baseline indicates improvement.
1 secondary outcome
Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6
Time frame: At Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41806309Brochet B, Langdon D, Havrdova EK, Lechner-Scott J, Montalban X, Patti F, Piehl F, Solari A, Hupperts R, Alexandri N, Lehn A, Smyk A, Selmaj K; CLARIFY-MS Investigators. Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study. Neurol Ther. 2026 Aug;15(4):1491-1507. doi: 10.1007/s40120-026-00897-0. Epub 2026 Mar 10.
- Derived from this study: PubMed 37978852Brochet B, Solari A, Lechner-Scott J, Piehl F, Langdon D, Hupperts R, Selmaj K, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, Montalban X, Kubala Havrdova E. Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study. Mult Scler. 2023 Dec;29(14):1808-1818. doi: 10.1177/13524585231205962. Epub 2023 Nov 18.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
92 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 92 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in France, Italy, Spain, Czechia, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Physical Health Composite Summary and Mental Health Composite Summary Scores at Month 24 (time frame: Baseline, Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.