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    Summary
    EudraCT Number:2012-000646-35
    Sponsor's Protocol Code Number:M13-375
    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:2013-06-24
    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 number2012-000646-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial Spondyloarthritis
    Estudio multicéntrico, aleatorizado, doble ciego para comparar la eficacia y seguridad del tratamiento continuo con adalimumab frente a la interrupción del tratamiento con adalimumab en el mantenimiento de la remisión en sujetos con espondiloartritis axial no radiográfica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial Spondyloarthritis
    Estudio multicéntrico, aleatorizado, doble ciego para comparar la eficacia y seguridad del tratamiento continuo con adalimumab frente a la interrupción del tratamiento con adalimumab en el mantenimiento de la remisión en sujetos con espondiloartritis axial no radiográfica
    A.4.1Sponsor's protocol code numberM13-375
    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 AddressAbbott House, Vanwall Business Park
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    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 Yes
    D.2.1.1.1Trade name Humira 40 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories 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.3.2Product code adalimumab
    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
    D.8 Placebo: 1
    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
    Axial Spondyloarthritis
    Espondiloartritis axial
    E.1.1.1Medical condition in easily understood language
    Axial SpA
    Artritis inflamatoria que afecta la columna vertebral
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10071400
    E.1.2Term Axial spondyloarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week (eow) subcutaneously (SC) in maintaining remission in subjects with non-radiographic axial Spondyloarthritis (nr-axSpA).
    El objetivo de este estudio es evaluar la eficacia y la seguridad del tratamiento continuo frente a la interrupción del tratamiento con 40 mg de adalimumab administrado por vía subcutánea (SC) cada dos semanas (cds) en el mantenimiento de la remisión en sujetos con espondiloartritis axial no radiográfica (EsA-ax-nr).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion:
    - Adult subjects with inadequate response to >/= 2 non-steroidal anti-inflammatories (NSAIDs)
    - Subject with axial SpA fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axial SpA classification criteria
    - Subject with evidence of active inflammation in the SI joints or spine on MRI, or elevated hs-CRP
    - Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit must be Negative
    - Ability to administer subcutaneous injections
    - General good health otherwise
    Criterios principales de inclusión
    - Sujeto adulto con una respuesta inadecuada >/= 2 antiinflamatorios no esteroides (AINE)
    - Sujeto con EsA-ax-nr que satisface los criterios de clasificación de espondiloartritis (EsA) axial de la Sociedad Internacional de Espondiloartritis (ASAS)
    - Sujeto con evidencia objetiva de inflamación activa en las articulaciones sacroiliacas (SI) o en la columna vertebral, en la resonancia magnética (RM) , o valores elevados de PCR-as
    - Test derivado proteico purificado (PPD) negativo y la radiografía del tórax en la visita de selección es negativa
    - Abilidad en administrar inyecciones subcutáneas
    - Por lo demás, buenas condiciones de salud en general
    E.4Principal exclusion criteria
    Main Exclusion:
    - Prior anti-TNF therapy
    - Fulfillment of modified New York criteria for Ankylosing Spondylitis
    - Recent infection requiring treatment
    - Significant medical events or conditions that may put patients at risk for participation
    - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
    - History of cancer, except successfully treated skin cancer
    - Recent history of drug or alcohol abuse
    Criterios pricipales de exclusión:
    - Previo tratamiento anti-TNF
    - Cumplimiento de los criterios modificados de espondilitis anquilosante de Nueva York
    - Infección reciente que requiera tratamiento
    - Eventos médicos significantes o condiciones que pongan en riesgo la participación del sujeto
    - Mujeres embarazadas o lactantes o que tengan previsto quedarse embarazadas durante el estudio
    - Antecedentes de cáncer, con excepción de cáncer de piel tratado con éxito
    - Antecedentes recientes de abuso de drogas o alcohol
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who do not experience a flare by Week 68 of the study where a flare is defined as having any 2 consecutive study visits with ASDAS >/= 2.1.
    La proporción de sujetos que no experimenten una exacerbación hasta la Semana 68. La exacerbación se define como 2 visitas consecutivas del estudio con ASDAS >/= 2.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The proportion of participants who do not experience a flare by Week 68 of the study where a flare is defined as having any 2 consecutive study visits with ASDAS >/= 2.1.
    La proporción de sujetos que no experimenten una exacerbación hasta la Semana 68. La exacerbación se define como 2 visitas consecutivas del estudio con ASDAS >/= 2,1.
    E.5.2Secondary end point(s)
    Secondary Efficacy Variable(s)
    At 12 weeks after initiation of Rescue Therapy, week 28 and week 68
    - ASDAS Inactive Disease (ASDAS < 1.3)
    - ASDAS Major Improvement (a change from baseline </= ?2,00 )
    - ASDAS Clinically Important Improvement (a change from baseline </= ?1,10)
    - ASAS20, ASAS40, ASAS 5/6 and ASAS Partial Remission
    - ASAS20 response: improvement of >/= 20% and absolute improvement of >/= 1 unit (on a scale of 0 to 10) from Baseline in >/= 3 of the following 4 domains, with no deterioration in the remaining domain (defined as a worsening of >/= 20% and a net worsening of >/= 1 unit)
    - Patient's Global Assessment - Represented by the PTGA-disease activity NRS score (0 to 10)
    - Pain - Represented by the patient's assessment of total back pain NRS score (0 to 10)
    - Function - Represented by the BASFI NRS score (0 to 10)
    - Inflammation - Represented by the mean of the 2 morning stiffness related BASDAI NRS scores (mean of items 5 and 6 of the BASDAI [0 to 10])
    - ASAS40 response: improvement of >/= 40% and absolute improvement of ? 2 units (on a scale of 0 to 10) from Baseline in >/= 3 of the 4 domains above in ASAS20 with no deterioration in the potential remaining domain
    - ASAS partial remission: absolute score of < 2 units for each of the 4 domains identified above in ASAS20
    - ASAS5/6 response: 20% improvement from Baseline in 5 out of the following 6 domains: BASFI, patient's assessment of total back pain, PTGA-disease activity, inflammation (mean of items 5 and 6 of the BASDAI]) lateral lumbar flexion from BASMI, and hs-CRP
    - Bath AS Disease Activity Index 50 (BASDAI50)
    Valoración secundarios de la eficacia
    A las 12 Semanas después del inicio del tratamiento de rescate, semana 28 y semana 68
    ? Enfermedad inactiva de ASDAS (ASDAS < 1,3)
    ? Mejoría importante de ASDAS (un cambio de </= ?2,00 frente al inicio del estudio)
    ? Mejoría clínica importante de ASDAS (un cambio de </= ?1,10 frente al inicio del estudio)
    ? ASAS20, ASAS40, ASAS 5/6 y remisión parcial en ASAS
    o Respuesta de ASAS20: mejoría de >/= 20% y mejoría absoluta de >/= 1 unidad (en una escala de 0 a 10) frente al inicio del estudio en >/= 3 de los siguientes 4 dominios, sin deterioro del dominio restante (definido como un empeoramiento >/= 20% y un empeoramiento neto de >/= 1 unidad)
    o Evaluación global del paciente ? Representada por la puntuación en la escala de valoración numérica (Numerical Rating Scale, NRS) de la valoración global del paciente de la actividad de la enfermedad (0 a 10)
    o Dolor ? Representado por la evaluación del paciente en la escala de valoración numérica (NRS) del dolor total de espalda (0 a 10)
    o Función ? Representada por la puntuación en la escala de valoración numérica de BASFI (0 a 10)
    o Inflamación ? Representada por la media de 2 puntuaciones en la escala de valoración numérica de BASDAI relacionadas con la rigidez matutina (la media de los reactivos 5 y 6 de BASDAI [0 a 10])
    o Respuesta de ASAS40: mejoría de >/= 40% y mejoría absoluta de >/= 2 unidades (en una escala de 0 a 10) frente al inicio del estudio en >/= 3 de los 4 dominios anteriores de ASAS 20, sin deterioro del posible dominio restante
    o Remisión parcial de ASAS: puntuación absoluta de < 2 unidades para cada uno de los 4 dominios identificados anteriormente en ASAS20
    o Respuesta de ASAS 5/6: una mejoría del 20% frente al inicio del estudio en 5 de los siguientes 6 dominios: BASFI, valoración del paciente del dolor total de espalda, valoración global del paciente de la actividad de la enfermedad, inflamación (media de los reactivos 5 y 6 de BASDAI), flexión lumbar lateral de BASMI y proteína C reactiva de alta sensibilidad.
    ? Índice de actividad de la espondilitis anquilosante de Bath de 50 (BASDAI50)
    ? Cuestionario de evaluación de la salud modificado para espondiloartropatías (HAQ-S)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 weeks after initiation of Rescue Therapy, week 28 and week 68
    A las 12 Semanas después del inicio del tratamiento de rescate, semana 28 y semana 68
    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 No
    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) Yes
    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 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) No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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
    Brazil
    Canada
    Mexico
    New Zealand
    Norway
    Puerto Rico
    Russian Federation
    Switzerland
    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
    the last 70 day follow-up call
    La última llamada telefónica de seguimiento a los 70 días
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 678
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 740
    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)
    Standard of Care
    Atención médica estándar
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-14
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