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    Summary
    EudraCT Number:2013-002358-57
    Sponsor's Protocol Code Number:M13-550
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-05
    Trial results View 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 number2013-002358-57
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy
    Estudio aleatorizado, doble ciego, controlado con placebo en fase 2 para investigar la seguridad y la eficacia de ABT-494 administrado con metotrexato (MTX) en pacientes con artritis reumatoide (AR) activa moderada o grave que han tenido una respuesta insuficiente o que no han tolerado el tratamiento biológico anti-TNF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy
    Estudio para investigar la seguridad y eficacia de ABT-494 administrado con metotrexato (MTX) en pacientes con AR activa moderada o grave que han demostrado una respuesta inadecuada o intolerancia a tratamientos biológicos anti-TNF
    A.4.1Sponsor's protocol code numberM13-550
    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 Inc.
    B.1.3.4CountryUnited States
    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 AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628773355
    B.5.5Fax number+441628644330
    B.5.6E-maileu-clinical-trials@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 3mg
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current 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 number3
    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: 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 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 12mg
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current 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 number12
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral 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 o 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 17.0
    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
    The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.
    El objetivo principal es comparar la seguridad y la eficacia de varias dosis de ABT-494 en comparación con placebo en pacientes con AR activa moderada o grave que reciben un tratamiento de base estable con MTX que presentaron una respuesta inadecuada o intolerancia a un tratamiento biológico anti-TNF.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male or female, at least 18 years old.
    2. Diagnosed with RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria for greater than or equal to 3 months.
    3. Subjects must have been receiving oral or parenteral MTX therapy greater than or equal to 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study.
    4. Subjects have been treated with 1 or 2 anti-TNF biologics for greater than 3 months but less than 3 years but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity within 1 year prior to initiating the study drug, provided that they did not exhibit, based on reported history, initial nonresponse to the agent (i.e., exclude subjects with no clinical response to initial treatment with anti-TNF biologic).
    5. Have active RA as defined by the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) at Screening and Baseline Visits; greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits; hs-CRP greater than 7 mg/L.
    1. Pacientes adultos de ambos sexos, de 18 años de edad como mínimo.
    2. Diagnosticados de AR según los criterios de 2010 del Colegio Americano de Reumatología/Liga Europea Contra el Reumatismo durante mas o igual de 3 meses.
    3. Los pacientes tienen que haber recibido tratamiento oral o parenteral con MTX durante mas o igual de 3 meses con una prescripción estable de 7,5 a 25 mg/semana durante al menos 4 semanas antes de iniciar la administración del fármaco del estudio. Los pacientes también deben recibir una dosis estable de ácido fólico (o equivalente) durante al menos 4 semanas antes de iniciar la administración del fármaco del estudio. Además, deben seguir recibiendo su dosis estable de MTX y ácido fólico durante todo el estudio.
    4. Los pacientes han recibido tratamiento con 1 o 2 agentes biológicos anti-TNF durante 3 meses o más, pero durante menos de 3 años, a pesar de lo cual continúan presentando AR activa, o tuvieron que suspender el tratamiento debido a problemas de tolerabilidad o efectos secundarios en el año anterior al inicio del fármaco del estudio, siempre que no hubieran presentado, según los antecedentes referidos, falta de respuesta inicialmente al fármaco (es decir, se excluye a los pacientes sin respuesta clínica al tratamiento inicial con un agente biológico anti-TNF).
    5. Tienen AR activa, definida por los siguientes criterios mínimos de enfermedad activa: 6 articulaciones inflamadas (según los recuentos de 66 articulaciones) o más en las visitas de selección e inicial; 6 articulaciones dolorosas (según los recuentos de 68 articulaciones) o más en las visitas de selección e inicial; PCR-as mas de 7 mg/l.
    E.4Principal exclusion criteria
    1. Reported history of no clinical response to initial treatment with anti-TNF biologic.
    2. Receipt of prior biologic therapy other than an anti-TNF (e.g., tocilizumab, rituximab, anakinra, or abatacept).
    3. Prior exposure to JAK inhibitor (e.g., tofacitinib, baricitinib).
    4. Receipt of any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to initiating the study drug.
    5. Current or expected need of other immunosuppressant medications, except MTX. Use of oral intake of greater than 10 mg prednisone/day or equivalent corticosteroid therapy.
    6. Laboratory values meeting the following criteria within 4 weeks prior to initiating study drug: Serum aspartate transaminase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN; Estimated glomerular filtration rate (eGRF) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula less than 40 mL/min/1.73 m2; Total white blood cell count (WBC) less than 3,000/μL; Absolute neutrophil count (ANC) less than 1,200 /μL; Platelet count less than 100,000/μL; Absolute lymphocytes count less than 500/ μL; Hemoglobin less than 9 gm/dL
    1. Refieren antecedentes de falta de respuesta clínica al tratamiento inicial con un agente biológico anti-TNF.
    2. Reciben un tratamiento biológico previo distinto de un anti-TNF (p. ej., tocilizumab, rituximab, anakinra o abatacept).
    3. Han recibido anteriormente un inhibidor de la cinasa JAK (p. ej., tofacitinib o baricitinib).
    4. Recibe un fármaco en investigación de naturaleza biológica o química en un período mínimo de 30 días o 5 semividas del fármaco (el período más largo de ellos) antes de iniciar el fármaco del estudio.
    5. Necesitan actualmente o se espera que necesiten otros medicamentos inmunodepresores, excepto MTX. Reciben una dosis oral de prednisona mayor de 10 mg/día o de un corticoesteroide equivalente.
    6. La analítica cumple los criterios siguientes en las 4 semanas anteriores al inicio del fármaco del estudio: Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) mas de 1,5 veces el LSN en suero; Filtración glomerular estimada (FGe) según la fórmula simplificada de 4 variables de la Modificación de la dieta en la nefropatía (Modification of Diet in Renal Disease, MDRD) menos de 40 ml/min/1,73 m2; Recuento total de leucocitos menos de 3.000/μl; Recuento absoluto de neutrófilos (RAN) menos de 1.200 /μl; Recuento de plaquetas menos de 100.000 /μl; Recuento absoluto de linfocitos menos de 500/μl; Hemoglobina menos de 9 g/dl
    E.5 End points
    E.5.1Primary end point(s)
    ACR20 response rate.
    Tasa de respuestas ACR20
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    ACR50/70 response rates, the proportion of subjects achieving low disease activity (LDA) (2.6 less or equal to DAS28 [CRP] less than 3.2) or clinical remission (CR) (DAS28 [CRP] less than 2.6), and the proportion of subjects achieving CR (DAS28 [CRP] less than 2.6)
    Tasas de respuesta ACR50/70 en la semana 12, la proporción de pacientes que alcancen una actividad baja de la enfermedad (LDA) (2,6 menor o igual a DAS28 [PCR] menor que 3,2) o remisión clínica (RC) (DAS28 [PCR] menor que 2,6), y proporción de pacientes que alcanzan la RC (DAS28 [PCR] menor que 2,6) en la semana 12.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Canada
    Czech Republic
    Hungary
    Netherlands
    Poland
    Puerto Rico
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Subjects who have completed the Week 12 visit during the randomized control treatment period will have the opportunity to enter the Open-Label Extension (OLE) Study M13 538 to receive ABT-494 in an open-label fashion.

    Subjects who do not enter the OLE study will have a follow-up visit approximately 30 days after the last administration of study drug.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    E.8.9.2In all countries concerned by the trial days0
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 250
    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)
    Subjects who have completed the Week 12 visit during the randomized control treatment period will have the opportunity to enter the Open-Label Extension (OLE) Study M13 538 to receive ABT-494 in an open-label fashion.
    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 Decision2014-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
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