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    Summary
    EudraCT Number:2015-003333-95
    Sponsor's Protocol Code Number:M14-465
    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:2016-01-19
    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 number2015-003333-95
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
    Estudio de fase 3, aleatorizado, doble ciego comparando ABT-494 con placebo y con adalimumab en sujetos con artritis reumatoide activa moderada a grave en tratamiento con metotrexato (MTX) en dosis estables y que no han respondido de forma adecuada a MTX (MTX-IR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)
    Estudio que compara ABT-494 con Placebo y con Adalimumab en pacientes con Artritis Reumatoide que están con dosis estables de Metotrexato y que tienen una respuesta inadecuada a Metotrexato ( SELECT-COMPARE)
    A.4.1Sponsor's protocol code numberM14-465
    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 number+34901200103
    B.5.5Fax number+441628461153
    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.3.9.2Current sponsor codeABT-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 number15
    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 Humira 40mg/0.8ml solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd.
    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 nameAdalimumab
    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/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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous 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) activa moderada a grave
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis (RA)
    Artritis Reumatoide (AR)
    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
    ? To compare the efficacy of ABT-494 QD versus placebo, and versus adalimumab (ADA) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in subjects with moderately to severely active RA who are on a on a stable background of methotrexate (MTX) and who have an inadequate response to MTX (MTX-IR).
    ? To compare the efficacy of ABT-494 QD versus placebo for the prevention of structural progression in RA subjects with moderately to severely active RA who are on a on a stable background of MTX and who have an inadequate response to MTX (MTX-IR).
    ? To compare the safety and tolerability of ABT-494 QD versus placebo, and versus ADA in subjects with moderately to severely active RA subjects who are on a stable background of MTX and who have an inadequate response to MTX (MTX-IR).
    ? To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA.
    - Comparar la eficacia de ABT-494 una vez al día (UVD) con la de un placebo y con la de adalimumab (ADA) para el tratamiento de los signos y los síntomas de la artritis reumatoide (AR) en pacientes con AR activa de moderada a grave con dosis estable de metotrexato (MTX) y que han respondido de forma insuficiente a MTX
    (MTX IR)
    - Comparar la eficacia de ABT-494 UVD con la de un placebo para la
    prevención de la progresión estructural en sujetos con AR activa de moderada a grave en dosis estable de metotrexato (MTX) y que han respondido de forma insuficiente a MTX (MTX IR)
    - Comparar la seguridad y la tolerabilidad de ABT-494 UVD con las de un placebo y las de ADA en pacientes con AR activa de moderada
    a grave en dosis estable con metotrexato (MTX) y que han respondido de forma insuficiente a MTX (MTX IR)
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Adult male or female, at least 18 years old.
    ? Diagnosis of RA for ? 3 months.
    ? Subjects must have been on oral or parenteral MTX therapy ? 3 months prior to the first dose of study drug.
    ? At least one of the following at Screening: ? 3 bone erosions on x-ray OR ? 1 bone erosion and a positive rheumatoid factor OR ? 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
    ? Subjects with prior exposure to at most one bDMARD (except ADA) may be enrolled (up to 20% of total study population)
    ? Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
    - Adulto hombre o mujer, con al menos 18 años de edad
    - Diagnóstico de AR durante ? 3 meses
    - Los sujetos llevarán ? 3 meses en tratamiento con MTX por vía
    oral o parenteral antes de la primera administración del fármaco del estudio.
    - Al menos uno de los siguientes requisitos en la selección: ? 3 erosiones óseas en la radiografía O ? 1 erosiones óseas y dar positivo para el factor reumatoide (FR) O ? 1 erosiones óseas y dar positivo para los autoanticuerpos frente a péptidos cíclicos citrulinados
    - Podrán participar los sujetos tratados previamente con un máximo de un FARMEb (excepto ADA; hasta el 20% de la población total del estudio)
    - Deberán haber dejado recibir todos los FARMEsc, excepto MTX
    E.4Principal exclusion criteria
    ? Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
    ? History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
    - Exposición previa a cualquier inhibidor de JAK (como tofacitinib, baricitinib y filgotinib, entre otros)
    - Antecedentes de artropatía inflamatoria distinta de la AR. Se
    permiten los antecedentes de síndrome de Sjögren secundario
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving ACR20 response at Week 12 / the proportion of subjects achieving clinical remission (CR) based on DAS28 (CRP) at Week 12
    La variable primaria es la proporción de pacientes que alcanzan una respuesta ACR20 en Semana 12/ proporción de pacientes que alcanzan la remisión clínica (RC) basada en el Das28 (PCR) en Semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    Semana 12
    E.5.2Secondary end point(s)
    ? Change from baseline in modified Total Sharp Score (mTSS) at Week 26
    ? Proportion of subjects achieving LDA at Week 12
    ? Change from baseline in Disease Activity Score (DAS) 28(CRP) at Week 12
    ? Change from baseline in Health Assessment Questionnaire (HAQ-DI) at Week 12
    ? ACR50 response at Week 12
    ? ACR70 response at Week 12
    ? Proportion of subjects achieving LDA based on DAS28 (CRP) ? 3.2 at Week 12
    ? Change from baseline in Short Form 36 (SF-36) PCS at Week 12
    ? Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12
    ? Proportion of subjects with no radiographic progression at Week 26
    ? Change from baseline in Work Stability Scale for Rheumatoid Arthritis (RA-WIS) at Week 12
    ? Change from baseline in morning stiffness (severity) at Week 12
    - Variación de DAS28 (PCR) desde el momento basal hasta la semana 12
    - Variación de la puntuación de Sharp total media (mTSS ) desde el momento basal hasta la semana 24
    - Variación de cuestionario de evaluación de la salud (HAQ-DI) desde el momento basal hasta la semana 12 - Respuesta ACR50 en la semana 12
    - Respuesta ACR70 en la semana 12 - Respuesta ACR50 en la semana 24
    -Variación del PCS del formulario abreviado 36 (SF-36) desde el momento basal hasta la semana 12
    - Proporción de pacientes que logran remisión clínica en la semana 12
    - Variación de evaluación funcional del tratamiento de las enfermedades crónicas ? cansancio (FACIT-F) desde el momento basal hasta la semana 12
    -Variación de escala de inestabilidad laboral para la artritis reumatoide (RA-WIS) desde el momento basal hasta la semana 12 - Variación de la rigidez matutina (intensidad) desde el momento basal hasta la semana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and Week 26
    Semana 12 y Semana 26
    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 No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA115
    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
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    Colombia
    Egypt
    European Union
    Hong Kong
    Israel
    Kazakhstan
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Puerto Rico
    Russian Federation
    Serbia
    Singapore
    South Africa
    Taiwan
    Turkey
    Ukraine
    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
    Última visita del último paciente o último contacto de seguimiento, lo que ocurra
    más tarde
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 1125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 375
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 468
    F.4.2.2In the whole clinical trial 1500
    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 pacientes pasarán al tratamiento estándar conforme al juicio clínico del investigador consultando con el médico del paciente del estudio. Los sujetos que discontinúen del estudio prematuramente serán tratados conforme al juicio 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 Decision2016-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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