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    Summary
    EudraCT Number:2013-001492-20
    Sponsor's Protocol Code Number:NN8226-4064
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-16
    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 number2013-001492-20
    A.3Full title of the trial
    A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate
    Ensayo en fase 2a, aleatorizado, doble ciego con comparador activo, multicéntrico y de grupos paralelos para investigar el mecanismo de acción de NNC0109 0012 (anticuerpo monoclonal anti-IL-20) mediante biopsias sinoviales en pacientes con artritis reumatoide y respuesta insuficiente a metotrexato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate
    Ensayo para investigar el mecanismo de acción de NNC0109-0012 (anti-IL-20 mAb) mediante biopsias sinoviales en sujetos con artritis reumatoide y respuesta insuficiente a metrotrexato.
    A.4.1Sponsor's protocol code numberNN8226-4064
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1141-3512
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    B.5.4Telephone number+34913 349 800
    B.5.6E-mailclinicaltrials@novonordisk.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.3.2Product code 0109-0012A 100 mg/ml
    D.3.4Pharmaceutical form Solution for injection
    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 INNN/A
    D.3.9.3Other descriptive nameNNC0109-0012
    D.3.9.4EV Substance CodeSUB30323
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number95 to 140
    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.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
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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) 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
    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
    Rheumatoid arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    RA, Rheumatoid arthritis, autoimmune disease that causes chronic joint inflammation
    AR, Artritis reumatoide, enfermedad autoinmune que produce inflamación crónica de las articulaciones
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 explore the potential differences in the mechanism of action through analysis of synovial biopsies in subjects with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) after 12 weeks of treatment with NNC0109-0012 and adalimumab
    Investigar posibles diferencias en el mecanismo de acción mediante un análisis de biopsias sinoviales en pacientes con artritis reumatoide (AR) activa y respuesta insuficiente a metotrexato (MTX) después de 12 semanas de tratamiento con NNC0109 0012 y adalimumab.
    E.2.2Secondary objectives of the trial
    ? To compare joint changes measured by magnetic resonance imaging (MRI) scans and ultrasound in subjects with active RA and an inadequate response to MTX after 12 weeks of treatment with NNC0109-0012 and adalimumab
    ? To compare changes in disease activity in subjects with active RA and an inadequate response to MTX after 12 weeks of treatment with NNC0109-0012 and adalimumab
    ? To describe the safety and tolerability of NNC0109-0012 and adalimumab in subjects with active RA and an inadequate response to MTX
    ? To compare changes in biomarkers in blood and synovial biopsies in subjects with active RA and an inadequate response to MTX after 12 weeks of treatment with NNC0109-0012 and adalimumab
    ? To compare changes measured by MRI scans and ultrasound, disease activity, biomarkers in blood and the safety and tolerability in subjects with active RA and an inadequate response to MTX after 12 weeks of treatment with NNC0109-0012 and adalimumab and additional 12 weeks of follow up
    Comparar alteraciones articulares medidas mediante RM y ecografía en pacientes con AR activa y respuesta insuficiente a MTX tras 12 semanas de tratamiento con NNC0109 0012 y adalimumab. Comparar variaciones de actividad de la enfermedad en pacientes con AR activa y respuesta insuficiente a MTX tras 12 semanas de tratamiento con NNC0109 0012 y adalimumab.Describir seguridad y tolerabilidad de NNC0109 0012 y adalimumab en pacientes con AR activa y respuesta insuficiente a MTX. Comparar las variaciones de los biomarcadores en sangre y biopsias sinoviales en pacientes con AR activa y respuesta insuficiente a MTX tras12 semanas de tratamiento con NNC0109 0012 y adalimumab.Comparar alteraciones medidas mediante RM y ecografía, las variaciones de la actividad de la enfermedad y los biomarcadores en sangre, así como la seguridad y tolerabilidad, en pacientes con AR activa y respuesta insuficiente a MTX tras12 semanas tratamiento con NNC0109 0012 y adalimumab y otras 12 de seguimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female age ?18 and ? 75 years at the time of signing informed consent.
    2. A diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010.
    3. Subjects with ACR global functional status of 1 to 3
    4. Active RA, characterised by:
    ? DAS28 (CRP) > 4.5 and
    ? ? 6 tender and ? 6 swollen joints based on a 66/68 joint count
    5. Active Synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency Power Doppler ultrasound scan at screening and randomisation
    1.Paciente de cualquier sexo con una edad comprendida entre los 18 y 75 años, ambos inclusive, en el momento de firmar el consentimiento informado.
    2.Diagnóstico de AR al menos 6 meses antes de la visita de selección, según los criterios del American College of Rheumatology (criterios EULAR/ACR de 2010) o criterios normalizados (ACR de 1987), cuando el diagnóstico se haya realizado antes de 2010.
    3.Estado funcional global del ACR de 1 a 3.
    4.AR activa, caracterizada por:
    ?DAS28-PCR ? 4,5 y
    ?Al menos 6 articulaciones dolorosas y al menos 6 articulaciones inflamadas, basándose en un recuento de 66/68 articulaciones.
    5.Sinovitis activa en al menos dos articulaciones de la muñeca y las articulaciones metacarpofalángicas, evaluada mediante ecografía de alta frecuencia con Doppler de potencia en los momentos de selección y aleatorización.
    E.4Principal exclusion criteria
    1. Subjects with arthritis due to other autoimmune diseases than RA
    2. Body weight > 90.0 kg
    3. History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile idiopathic arthritis, excluding secondary Sjogren syndrome and hypothyroidism)
    4. Any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
    5. Subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
    6. Female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highly effective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
    7. Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
    1.Pacientes con artritis por otras enfermedades autoinmunitarias distintas de la AR.
    2.Peso corporal > 90,0 kg.
    3.Antecedentes o presencia de una artropatía inflamatoria distinta de la AR (por ejemplo, gota, artritis psoriásica o reactiva, enfermedad de Lyme, artritis idiopática juvenil, excepto síndrome de Sjögren secundario e hipotiroidismo).
    4.Cualquier infección bacteriana activa o en curso en las 4 semanas previas a la visita de selección, salvo que se haya tratado y resuelto con el tratamiento adecuado, o antecedentes de infecciones recurrentes o procesos que predispongan a padecer infecciones crónicas (por ejemplo, bronquiectasias u osteomielitis crónica).
    5.Pacientes con una neoplasia maligna en los 5 años precedentes, a excepción de un carcinoma basocelular o espinocelular de la piel o un carcinoma in situ de cuello uterino debidamente tratado y curado, que haya aparecido más de 12 meses antes de la visita de selección.
    6.Mujeres embarazadas, en período de lactancia, con intención de quedarse embarazadas o, en caso de estar en edad fértil, no dispuestas a utilizar dos métodos anticonceptivos muy eficaces (se entiende por métodos anticonceptivos muy eficaces adecuados el uso establecido de métodos anticonceptivos hormonales orales, inyectables o implantables, esterilización o dispositivo o sistema intrauterino), uno de los cuales ha de ser un método anticonceptivo de barrera (por ejemplo, preservativo con espuma/gel/película/crema espermicida), durante 16 semanas (aproximadamente 5 semividas), como mínimo, después de la última dosis de la medicación del ensayo.
    7.Varones sexualmente activos que no hayan sido esterilizados por métodos quirúrgicos y que no estén dispuestos, o no lo estén sus parejas, a utilizar dos métodos anticonceptivos diferentes, uno de los cuales ha de ser un método anticonceptivo de barrera (por ejemplo, preservativo con espuma/gel/película/crema espermicida), durante todo el ensayo y hasta 16 meses (aproximadamente 5 semividas), como mínimo, después de la última dosis de la medicación del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the total histopathological synovitis score.
    Variación en la puntuación total de sinovitis histopatológica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12
    Entre el periodo basal y la semana 12
    E.5.2Secondary end point(s)
    Efficacy endpoints
    ? Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE)
    ? Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME)
    ? Changes in RA-MRI scores (RAMRIS) of synovitis
    ? Changes in RA-MRI scores (RAMRIS) of oedema
    ? Changes in RA-MRI scores (RAMRIS) of erosion
    ? Change in high frequency ultrasound with Power Doppler measures of total synovitis
    ? Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores
    ? Change in disease activity 28 ? C-reactive protein (DAS28 (CRP)

    Safety and tolerability endpoints
    1? Incidence of Adverse Events (AE)
    2? Incidence of local intolerability at the injection site
    ?Variación de la tasa inicial de captación (TIC) en RM con contraste dinámico (RM-CD)
    ?Variación de la tasa máxima de captación (TMC) en RM-CD
    ?Variación de la puntuación RAMRIS de sinovitis
    ?Variación de la puntuación RAMRIS de edema
    ?Variación de la puntuación RAMRIS de erosión
    ?Variación de la puntuación total de sinovitis en la ecografía de alta frecuencia con Doppler de potencia
    ?Variación de la puntuación total de tenosinovitis en la ecografía de alta frecuencia con Doppler de potencia
    ?Variación de la puntuación de actividad de la enfermedad 28?proteína C reactiva (DAS28-PCR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints
    ? From baseline to Week 12

    Safety and tolerability endpoints
    1? From baseline to Week 24
    2? From baseline until Week 24
    Criterios de valoración de la eficacia
    Desde periodo basal hasta la semana 12

    Criterios de valoración de la seguridad y toletabilidad
    1? Desde periodo basal hasta la semana 24
    2? Desde periodo basal hasta la semana 24
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) Yes
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    N/A
    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 Decision2014-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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