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    The EU Clinical Trials Register currently displays   42585   clinical trials with a EudraCT protocol, of which   7011   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-004505-32
    Sponsor's Protocol Code Number:COMB157G3301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004505-32
    A.3Full title of the trial
    An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS
    Etude multicentrique, randomisée, en ouvert, avec évaluateur indépendant, à bras parallèles, avec comparateur actif, pour évaluer l’efficacité et la tolérance de l’ofatumumab 20 mg administré chaque mois par voie sous-cutanée par rapport à un traitement de fond de première ligne choisi par le médecin, chez des patients atteints de sclérose en plaques récurrente récemment diagnostiquée (STHENOS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients
    A.3.2Name or abbreviated title of the trial where available
    STHENOS
    A.4.1Sponsor's protocol code numberCOMB157G3301
    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 Pharma AG
    B.1.3.4CountrySwitzerland
    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 Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henri Sainte Claire Deville, CS 40150
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@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 Kesimpta
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGlatiramer acetate
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.1CAS number 147245-92-9
    D.3.9.3Other descriptive nameGLATIRAMER ACETATE
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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 No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGlatiramer acetate
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.1CAS number 147245-92-9
    D.3.9.3Other descriptive nameGLATIRAMER ACETATE
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 No
    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 No
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameInterferon β-1b
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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.3.9.1CAS number 145155-23-3
    D.3.9.3Other descriptive nameINTERFERON BETA-1B
    D.3.9.4EV Substance CodeSUB12432MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    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 No
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameInterferon β-1a
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intraabdominal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterferon beta-1a
    D.3.9.1CAS number 220581-49-7
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30/0.5
    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 No
    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 No
    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.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameInterferon β-1a
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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 INNInterferon beta-1a
    D.3.9.1CAS number 220581-49-7
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22
    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 No
    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 No
    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.IMP: 7
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameInterferon β-1a
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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 INNInterferon beta-1a
    D.3.9.1CAS number 220581-49-7
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number44
    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 No
    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 No
    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.IMP: 8
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePeginterferon β-1a
    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.3.9.1CAS number 1211327-92-2
    D.3.9.3Other descriptive namePEGINTERFERON BETA-1A
    D.3.9.4EV Substance CodeSUB121165
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 No
    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 No
    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.IMP: 9
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTeriflunomide
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.4EV Substance CodeSUB25218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 No
    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.IMP: 10
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDimethyl fumarate
    D.3.4Pharmaceutical form Gastro-resistant capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 No
    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
    Sclérose en plaques
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclérose en plaques
    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
    Evaluate the efficacy of ofatumumab vs first line physician’s choice DMTs for self-administration in newly diagnosed/ treatment naïve RMS patient population at Month 15

    Evaluer l’efficacité de l’ofatumumab au Mois 15 par rapport à un traitement de fond de première ligne auto-administré choisi par le médecin chez des patients atteints de SEP-R récemment diagnostiqués/naïfs de traitement
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy to therapy of ofatumumab vs first line self-administered DMTs (physician’s choice) in newly diagnosed/naïve-treated RMS patient population
    - Evaluate the safety and tolerability of ofatumumab vs first line self-administered DMTs (physician’s choice) in newly diagnosed/naïve-treated RMS patient population
    -Evaluer l’efficacité du traitement par l’ofatumumab par rapport à un traitement de fond de première ligne auto-administré choisi par le médecin chez des patients atteints de SEP-R récemment diagnostiqués/naïfs de traitement
    -Evaluer la tolérance et la sécurité d’emploi de l’ofatumumab par rapport à un traitement de fond de première ligne auto-administré choisi par le médecin, chez des patients atteints de SEP-R récemment diagnostiqués/naïfs de traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent obtained before any assessment
    • Male/female patients, 18 through 45 (inclusive) years of age
    • Diagnosis of MS according to the 2017 revised McDonald criteria
    • Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014
    • Treatment Naïve patients, ≤ 3 years since first MS symptom
    • EDSS score: 0–3 (inclusive)
    • Patient must be suitable to be treated with one of first line self-administered DMT physician’s choice (glatiramer acetate, IFNs, teriflunomide or DMF, according to EMA SmPC) or ofatumumab depending on randomization and physician’s choice
    •At least 1 relapse or 1 Gd+ enhanced lesion on T1 in the year prior to Screening
    • Able to obtain MRI assessment
    Please see protocol for complete detailed list of inclusion criteria
    1. La signature du consentement éclairé doit être obtenue avant toute évaluation
    2. Patients masculins et féminins âgés de 18 à 45 ans (inclus)
    3. Patients avec un diagnostic de SEP selon les critères de McDonald révisés en 2017
    4. Patients atteints de SEP-Récurrente (SEP-R) selon la définition de Lublin et al, 2014
    5. Patients naïfs de tout traitement et ayant présenté leurs premiers symptômes depuis ≤ 3 ans
    6. Patients ayant un score EDSS compris entre 0 et 3 (inclus)
    7. Patients pour lesquels est approprié un traitement de fond de première ligne auto-administré (acétate de glatiramère, interférons [IFN], tériflunomide, diméthylfumarate, selon les résumés des caractéristiques des produits [RCP] approuvés par l’Agence européenne des médicaments) ou l’ofatumumab, selon la randomisation et le choix du médecin-investigateur concernant le traitement de fond
    8. Patients ayant présenté au moins une poussée, ou une lésion T1 rehaussée au gadolinium (Gd+) à l’IRM dans l’année précédant la sélection
    9. Patients chez lesquels la réalisation d’une IRM est possible
    Merci de vous référer au protocole pour la liste complète des critères d'inclusion
    E.4Principal exclusion criteria
    • Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
    • Progressive MS phenotypes: Patients with primary progressive MS or SPMS
    • Use of other experimental or investigational drugs
    • Relapse between Screening and Baseline visits
    • Pregnancy or breastfeeding
    • Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
    • Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while receiving ofatumumab and for 6 months after the last administration. The requirements for contraception for the comparators should also be taken into consideration according to their SmPC
    • Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
    • Patients with a chronic active infection until the infection is resolved. Where local regulation requires it, Sars-Cov-19 must be ruled out by the PCR test
    • Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
    • Patients at risk of developing or having reactivation of hepatitis
    • Patients at risk of developing or having reactivation of syphilis or tuberculosis (e.g. patients with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated). Testing for syphilis, HIV and tuberculosis will be done at
    Screening according to local clinical practice
    • Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
    • Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate or comply with the study procedures
    • Conditions or treatments that may impact the safety of the patient
    • Abnormal laboratory values as confirmed by the central laboratory prior to first study drug administration
    • Patients with severe hypoproteinemia e.g. in nephrotic syndrome
    • Patients with any of the following neurologic/psychiatric disorders prior to first study drug administration
    • Score “yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia- Suicide Severity Rating Scale (CSSRS) if this ideation occurred in the past 6 months
    OR
    • “yes” on any item of the Suicidal Behavior section, except for the “Non-Suicidal Self- Injurious Behavior” (item also included in the Suicidal Behavior section) if this behavior occurred in the past 2 years
    • History of hypersensitivity to the study drug or any of the excipients or to drugs of similar chemical classes
    Please see protocol for complete detailed list of exclusion criteria
    1. Patients atteints d’autres maladies que la SEP responsables de la présentation clinique ou des résultats de l’IRM
    2. Patients atteints de SEP à phénotype progressif : SEP progressive primaire ou SEP secondairement progressive
    3. Patients recevant un traitement expérimental
    4. Poussée entre les visites de sélection et de Baseline
    5. Femmes enceintes ou allaitantes
    6. Patients qui pourraient ne pas être capables ou ne pas vouloir coopérer ou se conformer aux exigences du protocole selon l’investigateur
    7. Les femmes en mesure d’avoir des enfants, à savoir toute femme physiologiquement apte à être enceinte, sauf si elles utilisent des méthodes de contraception très efficaces (taux d’échec inférieur à 1 %) pendant toute la période de traitement par ofatumumab et pendant les 6 mois suivant sa dernière administration. Les exigences de contraception avec les traitements comparateurs dépendent du traitement et sont présentées dans leurs RCP respectifs
    8. Patients atteints d’une maladie auto-immune chronique active (ou stable mais traitée par immunothérapie) autre que la SEP ou d’un syndrome d’immunodéficience
    9. Patients atteints d’une infection chronique active jusqu’à résolution de l’infection. Si les réglementations locales l’exigent, une infection par le virus de la COVID-19 doit être écartée par un test PCR
    10. Patients atteints de leucoencéphalopathie multifocale progressive confirmée ou présentant des signes neurologiques pouvant la suggérer.
    11. Patients à risque de développer une hépatite ou d’avoir une réactivation de leur hépatite.
    12. Patients à risque de développer une syphilis ou une tuberculose, ou d’avoir une réactivation de leur syphilis ou tuberculose (par ex. patients ayant une exposition connue ou des antécédents de syphilis, ou une tuberculose active ou latente, même si celle-ci a été traitée). Le dépistage de la syphilis, de la tuberculose et également du VIH sera effectué au moment de la sélection selon les pratiques cliniques locales
    13. Patients ayant reçu des vaccins vivants ou des vaccins vivants atténués au cours des 4 semaines précédant la première administration du traitement à l’étude
    14. Toute autre maladie ou condition pouvant interférer avec la participation à l’étude telle que prévue par le protocole ou avec la capacité des patients à coopérer ou à se conformer aux procédures de l’étude
    15. Toute autre maladie ou traitement pouvant avoir un impact sur la sécurité du patient
    16. Toute anomalie des paramètres biologiques suivante confirmée par le laboratoire central avant la première administration du traitement à l’étude
    17. Patients présentant une hypoprotéinémie sévère, par ex. liée à un syndrome néphrotique
    18. Patients présentant l’un des troubles neurologiques ou psychiatriques suivants avant la première administration du traitement à l’étude :
    • Réponse « oui » à la question 4 ou à la question 5 de la section Idéation suicidaire de l'échelle d'évaluation du comportement suicidaire - Université de Columbia (C-SSRS), si cette idéation est survenue dans les 6 derniers mois, OU
    • Réponse « oui » à n'importe quelle question de la section Comportement suicidaire, sauf en ce qui concerne le « Comportement d'automutilation sans intention suicidaire » (cette question figurant également dans la section Comportement suicidaire), si ce comportement est survenu au cours des 2 dernières années.
    19. Antécédents d’hypersensibilité au médicament à l’étude, à l’un de ses excipients ou aux médicaments de classes chimiques similaires
    Merci de vous référer au protocole pour la liste complète des critères d'exclusion
    E.5 End points
    E.5.1Primary end point(s)
    • NEDA-3 status (yes or no)
    NEDA-3 is defined as:
    1. Absence of confirmed clinical relapse
    2. Absence of new MRI activity (Gd+ T1 lesion or new/enlarged T2 lesion) with MRI re-baselined at Month 3
    3. Absence of 3-month confirmed disability worsening
    Statut NEDA-3 (oui ou non)
    • Absence de poussée clinique confirmée
    • Absence de nouvelle activité à l’IRM (lésions T1 rehaussées par gadolinium [Gd+] ou lésions T2 nouvelles ou élargies)
    • Absence d’aggravation du handicap confirmée à 3 mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Month 15
    Au mois 15
    E.5.2Secondary end point(s)
    • Number of relapses
    • Annual Relapse Rate (ARR)
    • Mean time to first relapse
    • Proportion of relapse-free patients at Month 3, 9 and 15
    • Proportion of relapse-free patients with MRI activity-free (no new Gd+ T1 lesion or new/enlarged T2 lesion) at Month 3, 9 and 15
    • Time to 3-month Confirmed Disability Worsening (3mCDW)
    • Time to 6-month Confirmed Disability Worsening (6mCDW)
    • Change in expanded disability status scale (EDSS) from baseline to end of study
    • Proportion of disability progression free patient at EoS
    • Number of Gadolinium enhancing (Gd+) T1 lesions of brain
    • Volume of Gd+ T1 lesions of brain
    • Number of new/enlarging T2 lesions of brain
    • Volume of new/enlarging T2 lesions of brain
    • Proportion of SAEs, and SAEs with hospitalizations between ofatumumab 20 mg s.c. and first line self-administered DMTs
    • Proportion of patients with adverse events, including injection related reactions
    • Proportion of patients who withdrew due to abnormal lab values
    • Proportion of treatment discontinuation or interruptions for safety/ tolerability reason
    • Compliance to treatment using patient diary

    • Nombre de poussées
    • Taux annualisé de poussées (TAP)
    • Délai moyen jusqu’à la première poussée
    • Proportion de patients avec absence de poussée aux Mois 3, 9 et 15
    • Proportion de patients avec absence de poussée et absence d’activité de la maladie à l’IRM (pas de nouvelle lésion T1 Gd+ ou de lésion T2 nouvelle/élargie) aux Mois 3, 9 et 15
    • Délai jusqu’à l’aggravation du handicap confirmée à 3 mois (3mCDW)
    • Délai jusqu’à l’aggravation du handicap confirmée à 6 mois (6mCDW)
    • Variation de l’EDSS de Baseline à la fin de l’étude
    • Proportion de patients avec absence de progression du handicap à la fin de l’étude
    • Nombre de lésions cérébrales T1 rehaussées par Gd
    • Volume des lésions cérébrales T1 rehaussées par Gd
    • Nombre de lésions cérébrales T2 nouvelles ou élargies
    • Volume des lésions cérébrales T2 nouvelles ou élargies
    • Proportion de patients présentant des évènements indésirables graves (EIG) et EIG avec hospitalisation,
    • Proportion de patients présentant des évènements indésirables, y compris des réactions liées à l'injection
    • Proportion de patients arrêtant prématurément pour des résultats biologiques anormaux
    • Proportion d’arrêts ou d’interruptions de traitement pour des raisons de tolérance/sécurité d’emploi
    • Compliance au traitement à l’aide du carnet patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Months 3, 6, 9, 12 and 15. For full details, please refer to the assessment schedule in the protocol.
    Aux mois 3, 6, 9, 12 et 15
    PPour plus de détails, vous référer au protocole
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Rater-Blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 236
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 236
    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)
    In the countries where ofatumumab is not approved by health authorities, commercially available and reimbursed, patients participating in the current study with ofatumumab clinical benefit in the opinion of the Investigator, a Post Trial Access Program (PTA) will be established to ensure continued treatment availability until the study participant or investigator stops treatment or the drug is locally reimbursed
    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 Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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