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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003874-30 | EudraCT Number |
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The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavenclad® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavenclad® | Drug | This low interventional extension study involves the follow up of participants in the parent study. The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants were not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48 | The SDMT is a test of information processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a "key", showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110 where higher scores indicated improvement and lower scores indicated worsening. | Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eva Maida | Vienna | Austria | ||||
| FN u sv. Anny Brno |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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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
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
A total of 280 participants were enrolled in the study from different study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mavenclad® | This low interventional extension study involves the follow up of participants in the parent study (NCT03369665). The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants are not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2021 | May 6, 2024 |
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| Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665) |
| Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years | 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. | Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665) |
| Brno |
| Czechia |
| FN Hradec Králové | Hradec Králové | Czechia |
| Nemocnice Jihlava, p.o. | Jihlava | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | Czechia |
| Faculty Hospital Kralovske Vinohrady | Prague | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia |
| Nemocnice Teplice | Teplice | Czechia |
| Glostrup Sygehus | Glostrup Municipality | Denmark |
| Odense Univeristy Hospital | Odense | Denmark |
| Centre hospitalier de la Côte Basque - Saint Léon | Bayonne | France |
| Pellegrin | Bordeaux | France |
| CHU de la Côte de Nacre | Caen | France |
| Centre Hospitalier de Gonesse | Gonesse | France |
| CHRU de Lille Hôpital Roger Salengro | Lille | France |
| CHU Hôpital Nord Laennec | Nantes | France |
| Hôpital de la Pitié-Salpétrière | Paris Cédex 13 | France |
| CHU de Poissy | Poissy | France |
| Centre Universitaire de Rouen | Rouen | France |
| CHU Tours - Hôpital Bretonneau | Tours | France |
| Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet | Budapest | Hungary |
| Semmelweis University II | Budapest | Hungary |
| Uzsoki Utcai Korhaz | Budapest | Hungary |
| Debreceni Egyetem Orvos- és Egészségtudományi Centrum | Debrecen | Hungary |
| Valeomed Kft | Esztergom | Hungary |
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór | NyÃregyháza | Hungary |
| A.O.U. Ospedali Riuniti Umberto | Ancona | Italy |
| University of Cagliari | Cagliari | Italy |
| PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania | Catania | Italy |
| Ospedale San Raffaele Giglio | Cefalù | Italy |
| Instituto Nazionale Neurologico "Carlo Besta" | Milan | Italy |
| Ospedale San Raffaele, IRCCS | Milan | Italy |
| A.O. Universitaria Federico II | Naples | Italy |
| Policlinico Università della Campania L. Vanvitelli | Naples | Italy |
| A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog | Palermo | Italy |
| Azienda Ospedaliera S. Camillo Forlanini | Roma | Italy |
| Neurological Center of Latium | Roma | Italy |
| Ospedale Sant'Andrea Neurologia - Università La Sapienza | Roma | Italy |
| Policlinico Tor Vergata | Roma | Italy |
| Zuyderland | Sittard-Geleen | Netherlands |
| COPERNICUS Podmiot Leczn. Sp z o.o. | Gdansk | Poland |
| M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM | Katowice | Poland |
| Centrum Neurologii Krzysztof Selmaj | Lodz | Poland |
| Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie | Lodz | Poland |
| Indywidualna Praktyka Lekarska Prof. Konrad Rejdak | Lublin | Poland |
| Centrum Medyczne Medyk | Rzeszów | Poland |
| Instytut Psychiatrii i Neurologii - Dept of Neurology II | Warsaw | Poland |
| Neuropoint s.r.o | Bratislava | Slovakia |
| Univerzitna nemocnica Martin | Martin | Slovakia |
| Fakultna nemocnica Nitra | Nitra | Slovakia |
| Fakultna nemocnica Trnava | Trnava | Slovakia |
| Hospital Universitario de Getafe | Getafe | Spain |
| C.A.U. de León - H. de León | León | Spain |
| Hospital Arnau de Vilanova | Lleida | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Spain |
| Hospital de Sant Joan Despà Moisès Broggi | Sant Joan Despà | Spain |
| Hospital Universitario Nuestra Senora de la Candelaria | Santa Cruz de Tenerife | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | Spain |
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set (FAS) included all eligible participants, for whom any Visit data had been collected after end date of CLARIFY MS Year 2 Visit (Month 24 Visit).
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| ID | Title | Description |
|---|---|---|
| BG000 | Mavenclad® | This low interventional extension study involves the follow up of participants in the parent study (NCT03369665). The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants are not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48 | The SDMT is a test of information processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a "key", showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110 where higher scores indicated improvement and lower scores indicated worsening. | Full analysis set (FAS) included all eligible participants, for whom any Visit data had been collected after end date of CLARIFY MS (NCT03369665) Year 2 Visit (Month 24 Visit). | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665) |
|
|
| |||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years | 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. | Full analysis set (FAS) included all eligible participants, for whom any Visit data had been collected after end date of CLARIFY MS (NCT03369665) Year 2 Visit (Month 24 Visit). Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665) |
| |||||||||||||||||||||||||||
| Secondary | Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years | 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. | Full analysis set (FAS) included all eligible participants, for whom any Visit data had been collected after end date of CLARIFY MS (NCT03369665) Year 2 Visit (Month 24 Visit). Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665) |
|
Up to 4 years after initial dose of Mavenclad® in parent study (NCT03369665).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mavenclad® | This low interventional extension study involves the follow up of participants in the parent study (NCT03369665). The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants are not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®. | 0 | 280 | 15 | 280 | 110 | 280 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA version 26.0. | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA version 26.0. | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 26.0. | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA version 26.0. | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.0. | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.0. | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2023 | May 6, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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