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    Summary
    EudraCT Number:2020-000350-96
    Sponsor's Protocol Code Number:IM101863
    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:2021-06-23
    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 number2020-000350-96
    A.3Full title of the trial
    A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate
    Estudio aleatorizado, de comparación directa, simple ciego, para evaluar la respuesta al tratamiento con abatacept frente a adalimumab, ambos subcutáneos y con metotrexato de base, en adultos con artritis reumatoide precoz, seropositiva, que tienen alelos de riesgo de Clase II del HLA para el “epitopo compartido” y tienen una respuesta insuficiente a metotrexato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate
    Eficacia de abatacept frente a adalimumab en la AR precoz, seropositiva y positiva para anticuerpos, que no respondieron bien a metotrexato.
    A.4.1Sponsor's protocol code numberIM101863
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1247-1367
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number+ 34 91 456 53 00
    B.5.6E-mailclinical.trials@bms.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 No
    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 nameAbatacept
    D.3.2Product code BMS-188667
    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.3.8INN - Proposed INNABATACEPT
    D.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeBMS-188667
    D.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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 Yes
    D.3.11.13.1Other medicinal product typeFusion protein
    D.IMP: 2
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Rheumatoid Arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Artritis reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority in efficacy of abatacept compared with adalimumab, both on background MTX, in achieving clinical response (ACR50) at Week 24, in early, seropositive (RF+ and ACPA+) RA patients with the SE HLA Class II risk alleles (ie, SE+).
    Demostrar la superioridad en eficacia de abatacept encomparación con adalimumab, en ambos casos, con MTX de base, para alcanzar respuesta clínica (ACR50) la semana24, en pacientes con AR precoz, seropositiva (FR+ y ACPA+) con los alelos de riesgo de clase II del HLA para el EC (es decir, EC+).
    E.2.2Secondary objectives of the trial
    To compare the efficacy of abatacept with adalimumab, both on background MTX in achieving:
    - clinical remission criteria (DAS28-CRP remission) at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+).
    - clinical response (ACR50) at Week 24 in the whole study population of early, seropositive RA patients.
    - clinical remission criteria (CDAI remission) at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+).
    - improvement in pain at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+).

    To determine:
    - the efficacy over time by treatment in early, seropositive RA patients (SE+ subset and whole population).
    - the improvement in health-related quality of life over time by treatment in early, seropositive RA patients (SE+ subset and whole population).
    Comparar la eficacia de abatacept con adalimumab, ambos con MTX de base, para alcanzar:
    - criterios de remisión clínica (remisión DAS28-PCR) la semana 24 en pacientes con AR precoz, seropositiva, con alelos de riesgo de clase II del HLA para el EC (EC+)
    - respuesta clínica (ACR50) la semana 24 en la población total del estudio de pacientes con AR precoz, seropositiva.
    - criterios de remisión clínica (remisión CDAI) la semana 24 en pacientes con AR precoz, seropositiva, con alelos de riesgo de clase II del HLA para el EC (EC+)
    - mejoría en el dolor la semana 24 en pacientes con AR precoz, seropositiva, con alelos de riesgo de clase II del HLA para el EC (EC+)

    Determinar:
    - eficacia a lo largo del tiempo por tratamiento en pacientes con AR precoz, seropositiva (subgrupo EC+ y población total)
    - mejoría en la calidad de vida relacionada con la salud a lo largo del tiempo por tratamiento en pacientes con AR temprana, seropositiva (subgrupo EC+ y población completa)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period
    - Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
    - Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization
    - Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening
    - At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening
    - At least 3 tender and at least 3 swollen joints at screening and at randomization
    - Artritis reumatoide (AR) precoz, definida como síntomas de AR que aparecieron ≤ 12 meses antes del screening and cumplieron los criterios ACR/EULAR 2010 para la clasificación de la AR en algún momento durante el periodo de 12 meses
    - Naive a cualquier FAME dirigido (biológico o no biológico), FAMES convencionales sintéticos distintos a MTX, y otros tratamientos de investigación para AR
    - Tratamiento con MTX durante al menos 12 semanas, con una dosis estable de MTX oral o parenteral durante al menos 4 semanas antes de la aleatorización
    - Test anti-CCP-2 que es > 3× LSN y positividad para el FR de acuerdo a los ensayos del laboratorio central en el screening
    - Al menos DAS28-CRP ≥ 3,2 en el screening
    - Al menos 3 articulaciones dolorosas y 3 articulaciones inflamadas en el screening y la aleatorización
    E.4Principal exclusion criteria
    - Women who are breastfeeding
    - Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia
    - History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
    - At risk for tuberculosis
    - Recent acute infection
    - History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
    - History of infection of a joint prosthesis or artificial joint
    - History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis)
    - History of primary immunodeficiency
    - Current clinical findings or a history of a demyelinating disorder
    - 5 or more joints cannot be assessed for tenderness or swelling
    - Mujeres que estén amamantando
    - Enfermedades autoinmunes distintas de la AR (tales como psoriasis, lupus eritomatoso sistémico, vasculitis, espondiloartritis seropositiva, enfermedad inflamatoria intestinal, síndrome Sjogren), o con fibromialgia activa
    - Historial previo de enfermedad inflamatoria de las articulaciones distinta a la AR (tales como artritis psoriásica, gota, artritis reactiva, enfermedad de Lyme)
    - Riesgo de tuberculosis
    - Infección aguda reciente.
    - Historial de infección bacteriana crónica o recurrente (ej: pielonefritis crónica, osteomielitis, bronquiectasia)
    - Historial de infección de una protesis en la articulación o articulación artificial
    - Historial de infecciones fúngicas sistémicas (tales como histoplasmosis, bastomicosis, o coccidioidomicosis)
    - Historial de inmunodeficiencia primaria
    - Hallazgos clínicos de trastorno demielinizante o historial de trastorno demielinizante
    - 5 o más articulaciones que no puedan evaluarse respecto al dolor o la inflamación
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of SE+ participants meeting ACR50 response at Week 24
    Porcentaje de participantes EC+ que cumplen la respuesta ACR50 en la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 24
    En la semana 24
    E.5.2Secondary end point(s)
    1. Proportion of SE+ participants achieving DAS28-CRP remission (DAS28-CRP < 2.6) at Week 24
    2. Proportion of whole study population participants meeting ACR50 response at Week 24
    3. Proportion of SE+ participants achieving CDAI remission (CDAI ≤ 2.8) at Week 24
    4. Mean change from baseline in SE+ participant-reported pain (VAS) at Week 24
    5. Proportion of SE+ subset and whole population achieving ACR20/50/70 responses, DAS remission, CDAI remission, SDAI remission over the SBTP and OLTP; mean changes from baseline in DAS28-CRP, CDAI, SDAI over the SBTP and OLTP; mean changes from baseline in the 7 ACR core components over the SBTP and OLTP
    6. Mean change from baseline in SF-36 in SE+ subset and whole population at Week 24 and Week 104 (4 physical and 4 mental subscales and the physical component and mental component summary)
    1. Porcentaje de participantes EC+ que alcancen remisión en DAS28-PCR (DAS28-PCR < 2,6) la semana 24
    2. Porcentaje de participantes de la población total del estudio que cumplen la respuesta ACR50 en la semana 24
    3. Porcentaje de participantes EC+ que alcancen remisión en CDAI (CDAI ≤ 2,8) la semana 24
    4. Variación media respecto al momento basal en el dolor notificado por los pacientes EC+ (EVA) la semana 24
    5. Porcentaje del subgrupo EC+ y de la población completa que alcanzaron respuestas ACR20/50/70, remisión en DAS, remisión en CDAI, remisión en SDAI a lo largo del PTSC (periodo de tratamiento simple-ciego) y el PTA (periodo de tratamiento abierto); Variaciones medias respecto al momento basal en DAS28-PCR, CDAI, SDAI en el PTSC y el PTA; Variaciones medias respecto al momento basal en los 7 componentes clave de ACR en el PTSC y el PTA
    6. Variación media respecto al momento basal en el SF-36 en el subgrupo EC+ y en la población completa la semana 24 y la semana 104 (4 subescalas físicas y 4 mentales y el resumen del componente físico y el componente mental)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. At Week 24
    5. Over the SBTP and OLTP
    6. At Week 24 and Week 104
    1-4. En la semana 24
    5. A lo largo del PSTC y PTA
    6. En la semana 24 y semana 104
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Australia
    Japan
    Mexico
    Taiwan
    United States
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    End of trial is defined as last visit for the last participant.
    El fin del ensayo se define como la última visita del último participante.
    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 months4
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days22
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In situations where consent cannot be given by subjects/participants, their legally acceptable representatives (as per country guidelines) are clearly and fully informed regarding clinical studies in which the participant volunteers to participate.
    En situaciones en que los participantes no puedan proporcionar el consentimiento informado,sus representes legales (según directrices del país) serán informados de forma clara y completa sobre los estudios en que el sujeto participe voluntariamente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 400
    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)
    At the end of the open-label treatment period, BMS will not continue to provide BMS-supplied study treatment to participants/investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study.
    Al final del periodo de tratamiento abierto, BMS no continuará proporcionando el tratamiento de estudio suministrado por BMS a los participantes/investigadores a menos que BMS decida extender el estudio. El investigador debe asegurar que el participante recibe el estándar de tratamiento apropiado para tratar la condición bajo estudio
    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 Decision2021-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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