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    Summary
    EudraCT Number:2016-000933-37
    Sponsor's Protocol Code Number:M15-925
    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:2016-11-17
    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 number2016-000933-37
    A.3Full title of the trial
    A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
    Estudio de fase 3, aleatorizado, con comparador activo, doble ciego para comparar ABT-494 con abatacept en sujetos con artritis reumatoide de actividad moderada a grave con respuesta insuficiente o intolerancia a los FARME biológicos (FARMEb) en tratamiento estable con fármacos antirreumáticos modificadores de la enfermedad sintéticos convencionales (FARMEsc)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)
    Estudio para comparar ABT-494 con abatacept en sujetos con Artritis Reumatoide que están tomando una dosis estable de fármacos antirreumáticos modificadores de la enfermedad sintéticos convencionales (FARMEsc) que han tenido una respuesta inadecuada o intolerancia a un FARME biológico.
    A.4.1Sponsor's protocol code numberM15-925
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34901 20 01 03
    B.5.6E-mailabbvie_reec@abbvie.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 nameABT-494
    D.3.4Pharmaceutical form 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 INNABT-494
    D.3.9.1CAS number 1310726-60-3
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    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.2.1.1.1Trade name ORENCIA 250mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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.3.1Product nameAbatacept
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Rheumatoid Arthritis (RA)
    Artritis reumatoide (AR) con actividad de moderada a grave
    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 19.0
    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
    1. To compare the safety and efficacy of ABT-494 versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-intolerant subjects with moderately to severely active RA.
    2. To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA.
    1. Comparar la seguridad y eficacia de ABT-494 frente a abatacept intravenoso (IV) para el tratamiento de los signos y síntomas de la artritis reumatoide (AR) en sujetos con artritis reumatoide de moderada a severa que son respondedores inadecuados a FARMEb (FARMEb-RI) o presentan intolerancia a FARMEb.
    2. Evaluar la seguridad, tolerabilidad y eficacia a largo plazo de ABT-494 en sujetos con A
    E.2.2Secondary objectives of the trial
    1. ACR20 response rate at Week 12 (non-inferiority);
    2. Change from baseline in DAS28 (CRP) at Week 12 (non-inferiority);
    3. Change from baseline in DAS28 (CRP) at Week 12 (superiority).
    1. Ratio de respuesta ACR20 en la Semana 12 (no inferioridad);
    2. Cambio desde basal en DAS28 (PCR) en Semana 12 (no inferioridad);
    3. Cambio desde basal en DAS28 (PCR) en Semana 12 (superioridad)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male or female, at least 18 years old.
    2. Diagnosis of RA for ≥ 3 months.
    3. Subjects have been treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration and have never received abatacept prior to the first dose of study drug.
    4. Subjects have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
    5. Meets the following criteria: ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits and hsCRP ≥ 3 mg/L at Screening.
    1. Hombre o mujer adulto, de al menos 18 años.
    2. Diagnóstico de AR desde hace ≥ 3 meses
    3. Pacientes que han sido tratados durante ≥ 3 meses con ≥ 1 FARMEb, pero continúan mostrando AR activa o han discontinuado por intolerancia o toxicidad, independientemente de la duración del tratamiento y nunca han recibido abatacept antes de la primera dosis del fármaco del estudio.
    4. Sujetos que han estado recibiendo una terapia de FARMEsc durante ≥ 3 meses y en una dosis estable durante ≥ 4 semanas, antes de la primera dosis del fármaco del estudio. Se permiten los siguientes FARMEsc: MTX, sufasalazina, hidroxicloroquina, cloroquina y leflunomida. Se permite una combinación de hasta 2 FARMEsc de fondo excepto la combinación MTX y leflunomida.
    5. Cumplen el siguiente criterio: ≥ 6 articulaciones inflamadas (basado en el recuento de 66 articulaciones) y 6 articulaciones sensibles (basado en el recuento de 68 articulaciones) en las visitas de selección y basal, y PCR-hs ≥ 3 mg/L en selección.
    E.4Principal exclusion criteria
    1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
    2. Prior exposure to abatacept
    3. History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
    1. Exposición previa a cualquier inhibidor de janus quinasas (JAK) (incluyendo, pero no limitado a tofacitinib, baricitinib y filgotinib).
    2. Exposición previa a abatacept
    3. Historial de enfermedad inflamatoria de las articulaciones distinta a la AR. Se permite historial de Síndrome de Sjogren secundario.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving low disease activity (LDA) at Week 12. LDA is defined as Disease Activity Score (DAS)28 (C-reactive protein [CRP]) ≤ 3.2 (non-inferiority).
    El resultado primario es la proporción de sujetos que consiguen una baja actividad de la enfermedad (LDA) en la semana 12. El LDA se define como la puntuación de actividad de la enfermedad DAS28 (proteína C reactiva [PRC]) ≤ 3.2 (no inferioridad).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    1. ACR20 response rate at Week 12 (non-inferiority);
    2. Change from baseline in DAS28 (CRP) at Week 12 (non-inferiority);
    3. Change from baseline in DAS28 (CRP) at Week 12 (superiority).
    1. Ratio de respuesta ACR20 en Semana 12 (no inferioridad);
    2. Cambio desde basal en DAS28 (PCR) en Semana 12 (no inferioridad);
    3. Cambio desde basal en DAS28 (PCR) en Semana 12 (superioridad).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Abatacept
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Belarus
    Brazil
    Canada
    Chile
    Colombia
    European Union
    Israel
    Korea, Democratic People's Republic of
    Mexico
    New Zealand
    Norway
    Puerto Rico
    Russian Federation
    Switzerland
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS or last follow up contact whichever is later
    LVLS o el ultimo seguimiento telefónico, lo que ocurra más tarde
    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 months7
    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 months7
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 300
    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 study, subjects will be placed on standard of care per Investigator's clinical judgment in consultation with the study subject's physician. Subjects that prematurely discontinue from the study will be treated in accordance with the Investigator's clinical judgment.
    Al final del estudio, los sujetos se colocarán en práctica clínica habitual a criterio clínico del investigador en colaboración con el médico del sujeto del estudio. Los sujetos que discontinúen prematuramente del estudio serán tratados de acuerdo al criterio clínico del investigador.
    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 Decision2016-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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