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    Summary
    EudraCT Number:2019-001341-40
    Sponsor's Protocol Code Number:COMB157G23101
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-001341-40
    A.3Full title of the trial
    A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy
    Estudio multicéntrico, abierto, prospectivo y de brazo único para evaluar la efectividad del tratamiento con ofatumumab y los resultados comunicados por el paciente, en pacientes con esclerosis múltiple recurrente que pasan de dimetilfumarato o fingolimod a ofatumumab.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab
    Estudio abierto en el que se evalúa la efectividad del tratamiento con ofatumumab y los PRO en pacientes con EMR que pasan de dimetilfumarato o fingolimod a ofatumumab.
    A.3.2Name or abbreviated title of the trial where available
    ARTIOS
    ARTIOS
    A.4.1Sponsor's protocol code numberCOMB157G23101
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34933064464
    B.5.6E-maileecc.novartis@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Arzerra
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameofatumumab
    D.3.2Product code OMB157
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOFATUMUMAB
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeOMB157
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple sclerosis
    Esclerosis múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    Esclerosis múltiple
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the effectiveness of ofatumumab 20 mg s.c. administered every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate or fingolimod
    Demostrar la efectividad de ofatumumab 20 mg s.c., administrado cada 4 semanas en pacientes con formas recurrentes de EM que hayan presentado actividad de la enfermedad a pesar del tratamiento con dimetilfumarato o fingolimod
    E.2.2Secondary objectives of the trial
    Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate or fingolimod
    Evaluar la seguridad de ofatumumab 20 mg s.c. administrado cada 4 semanas en pacientes con formas recurrentes de EM que hayan presentado actividad de la enfermedad a pesar del tratamiento con dimetilfumarato o fingolimod
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of MS according to the 2017 Revised McDonald criteria
    • Relapsing MS: relapsing forms of MS (RMS)including RMS and secondary progressive MS (SPMS) Lublin et al 2014
    • Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
    • MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs)
    • Subject transitioning from either fingolimod or dimethyl fumarate which was administered for a period of at least 6 months, as their last DMT before first study drug administration
    • Breakthrough disease activity while the participant was adequately using fingolimod or dimethyl fumarate prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
    • Neurologically stable within one month prior to first study drug administration
    • Diagnóstico de EM según los criterios McDonald revisados de 2017
    • EM recurrente: formas recurrentes de EM (EMR) incluyendo EMR y EM secundaria progresiva (EMPS) Lublin et al., 2014.
    • Estado de discapacidad en la selección definido por una puntuación en la Expanded Disability Status Scale (EDSS) de 0 a 4 (ambas incluidas).
    • Tratamiento previo de la EM con un máximo de 3 tratamientos modificadores de la enfermedad (TME).
    • Pacientes que hayan recibido fingolimod o dimetilfumarato durante un periodo de al menos seis meses como su último TME antes de la primera administración del fármaco del estudio.
    • Presencia de actividad de la enfermedad a pesar de que el paciente haya tomado fingolimod o dimetilfumarato de forma adecuada durante un mínimo de seis meses antes de pasar a ofatumumab y evidenciado por uno o más brotes clínicos o uno o más signos de actividad en resonancia magnética (RM) (p. ej., lesiones Gd+, lesiones nuevas/aumentadas en T2).
    • Estabilidad neurológica durante el mes anterior a la primera administración del fármaco del estudio.
    E.4Principal exclusion criteria
    • Subjects with primary progressive MS Polman et al 2011 or SPMS without disease activity Lublin et al 2014
    • Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al 2015)
    • Disease duration of more than 10 years since diagnosis
    • Pregnant or nursing(lactating) women
    • Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 12 months after stopping study medication
    • Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
    • Subjects with active systemic bacterial, viral or fungal infections, or known to have Acquired Immunodeficiency Syndrome (AIDS)
    • Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
    • Subjects at risk of developing or having reactivation of syphilis or
    tuberculosis
    • Subjects at risk of developing or having reactivation of hepatitis: positive results at screening for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
    • Have received any live or live-attenuated vaccines within 2 months prior to first study drug administration
    • Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, etc.)
    • Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the subjects to cooperate or comply with the study procedures
    • Pacientes con EM primaria progresiva (Polman et al., 2011) o EMSP sin actividad de la enfermedad (Lublin et al., 2014).
    • Pacientes que cumplan los criterios de neuromielitis óptica (Wingerchuk et al., 2015).
    • Duración de la enfermedad superior a 10 años desde el diagnóstico.
    • Mujeres embarazadas o en periodo de lactancia.
    • Mujeres en edad fértil a menos que estén utilizando métodos anticonceptivos altamente eficaces durante la administración de la medicación del estudio y durante al menos 12 meses después de suspender la medicación del estudio.
    • Pacientes con enfermedad activa crónica del sistema inmune que no sea EM o con síndrome de inmunodeficiencia.
    • Pacientes con infecciones bacterianas, víricas o fúngicas sistémicas activas o síndrome de inmunodeficiencia adquirida (SIDA).
    • Pacientes con hallazgos neurológicos que coincidan con la leucoencefalopatía multifocal progresiva (LMP) o con LMP confirmada.
    • Pacientes con riesgo de desarrollar o presentar reactivación de sífilis o tuberculosis.
    • Pacientes con riesgo de desarrollar o presentar reactivación de hepatitis: resultados positivos en la selección en marcadores serológicos de hepatitis A, B, C y E que indiquen una infección aguda o crónica.
    • Pacientes que hayan recibido alguna vacuna viva o viva-atenuada durante los dos meses anteriores a la primera administración del fármaco del estudio.
    • Pacientes que hayan recibido tratamiento con medicación específica o en dentro de los márgenes de tiempo especificados (p. ej., corticosteroides, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, ciclofosfamida, etc.).
    • Cualquier otra enfermedad o afección que pudiera interferir en la participación en el estudio según el protocolo del estudio o en la capacidad de los pacientes para cooperar o cumplir los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks
    Tasa anualizada de brotes (TAB, basada en brotes confirmados) a las 96 semanas
    E.5.1.1Timepoint(s) of evaluation of this end point
    96 weeks
    96 semanas
    E.5.2Secondary end point(s)
    • Proportion of subjects with adverse events, including injection related reactions
    • Proportion of patients with laboratory or vital signs results meeting abnormal criteria
    • The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons
    - Proporción de pacientes con acontecimientos adversos, incluyendo reacciones relacionadas con la inyección
    - Proporción de pacientes con acontecimientos adversos, resultados de pruebas analíticas o constantes vitales que cumplan criterios anómalos
    - Proporción de pacientes que discontinúan el tratamiento debido a efectividad insuficiente )falta de eficacia) o razones de tolerabilidad/seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    96 weeks
    96 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Lebanon
    Mexico
    Norway
    Poland
    Portugal
    Russian Federation
    Saudi Arabia
    Slovakia
    Spain
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Study completion is defined as when the last subject finishes their Study Completion visit and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator or, in the event of an early study termination decision, the date of that decision.
    La Finalización del Estudio se define como el momento en el que el último sujeto completa su visita de evaluación final y cualquier procedimiento repetido asociado a esta visita haya sido documentado y seguido apropiadamente por el investigador o, en el caso de una finalización temprana del estudio, la fecha de la toma de dicha decisión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 550
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 289
    F.4.2.2In the whole clinical trial 550
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who complete the End of Study (EOS) visit on study drug, could enter the planned umbrella extension study. All patients who are prematurely withdrawn from the study will be provided with follow-up medical care or referred to appropriate ongoing care by investigators. Patients who complete the EOS on study drug but do not enter the umbrella extension study or patients who prematurely discontinue study drug and complete their EOS visits will enter the Safety Followup.
    Pac. que finalicen la visita de Fin de Estudio (EOS) tras completar tratamiento (tto.) pueden entrar en un estudio de extensión. Todos los Pac. que discontinúen prematuramente del estudio recibirán cuidados médicos apropiados o serán referidos a quien pueda proporcionárselos. Pac. que finalicen la visita de EOS tras completar tto., pero no entren en el estudio de extensión y los que discontinúen prematuramente del estudio y que finalicen la visita de EOS entrarán en el seguimiento de seguridad.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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