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    Summary
    EudraCT Number:2017-000901-19
    Sponsor's Protocol Code Number:PSA‐PI‐006421
    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:2017-08-04
    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 number2017-000901-19
    A.3Full title of the trial
    Evaluation of the clinical and echographic response to Apremilast through clinical evaluation and through a joint-periarticular-nail echographic index in patients with active psoriatic arthritis.
    Evaluación de la respuesta clínica y ecográfica a Apremilast mediante evaluación clínica y mediante un índice ecográfico articular-periarticular-ungueal en pacientes con artritis psoriásica activa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the clinical and echographic response to Apremilast through clinical evaluation and through a joint-periarticular-nail echographic index in patients with active psoriatic arthritis.
    Evaluación de la respuesta clínica y ecográfica a Apremilast mediante evaluación clínica y mediante un índice ecográfico articular-periarticular-ungueal en pacientes con artritis psoriásica activa.
    A.3.2Name or abbreviated title of the trial where available
    APREMILAST
    APREMILAST
    A.4.1Sponsor's protocol code numberPSA‐PI‐006421
    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 SponsorFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Europe Ltd
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    B.5.2Functional name of contact pointJuan José de agustín de Oro
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall d'Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number34934894189
    B.5.6E-mailjjdagustin@vhebron.net
    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 Otezla
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1180
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.4Pharmaceutical form Film-coated 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 INNAPREMILAST
    D.3.9.1CAS number 608141-41-9
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasic arthritis
    Artritis psoriásica
    E.1.1.1Medical condition in easily understood language
    Psoriasic arthritis
    Artritis psoriásica
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To obtain a 20% reduction in the echographic index at 12 months after the introduction of Apremilast in study patients
    Obtener una reducción del 20 % en el índice ecográfico a 12 meses tras la introducción de Apremilast en los pacientes del estudio
    E.2.2Secondary objectives of the trial
    - To obtain a reduction of 50 and 70% in the echographic index at 12 months after the introduction of Apremilast in the study patients
    - To evaluate the nail echographic lesions associated to PA
    - To detect nail changes in relation to treatment with Apremilast
    - To correlate the nail changes with the changes in the articular/enthesis echographic index.
    - To correlate the echographic variables
    - Changes in the nº of swollen and painful joints
    - Patient EVA (0-100 mm) or VGP, EVA medical (0-100 mm)
    - Changes in the index of LEI
    - Changes in the PCR and VSG
    - Evaluation of HLA B-27, peptids anti CCP and rheumatoid factor
    - Obtener una reducción del 50 y 70 % en el índice ecográfico a 12 meses tras la introducción de Apremilast en los pacientes del estudio
    - Evaluar las lesiones ungueales ecograficas asociadas a la APs
    - Detectar cambios ungueales en relación al tratamiento con Apremilast
    - Correlacionar los cambios ungueales con los cambios en el índice ecográfico articular/entésico.
    - Correlacionar las variables ecograficas
    - Cambios en el nº de articulaciones inflamadas y dolorosas
    - EVA paciente (0-100 mm) o VGP, EVA médico (0-100 mm)
    - Cambios en el índice de LEI
    - Cambios en la PCR y VSG
    - Evaluación HLA B-27, péptidos anti CCP, y factor reumatoide.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults equal or over 18 years with Psoriatic Arthritis (PAs) according to CASPAR criteria (Classification Criteria for Psoriatic Arthritis) at the time of selection with involvement of hands and / or feet with active clinical disease (more than two inflamed joints)
    - To have 2 or more joints with echographic synovitis at the screening visit
    - To have 1 or more echographically affected enthesis at the screening visit
    - To accept and to sign the informed consent of the study
    - Ability to comply with all tests and visits of specified protocol and to have a permanent address.
    - Women of childbearing age should have a negative pregnancy test at the baseline visit. Women of childbearing age who participate in the study should use one of the following contraceptive methods throughout the trial and at least up to 28 days after taking the last dose of study medication.
    Approved contraceptive options are:
    · Option 1: Any of the following: hormonal contraceptives (eg, birth control pills, injection, implant, transdermal patch, vaginal ring); Intrauterine device (IUD); tubal ligation; Or that your partner has had a vasectomy
    OR
    · Option 2: male or female condom (a latex condom or non-latex condom BUT NOT made of a natural [animal, eg polyurethane] membrane) AND one of the following additional barrier methods: a) Diaphragm with spermicide; B) cervical cap with spermicide; Or c) contraceptive sponge with spermicide.
    - Adultos iguales o mayores de 18 años con Artritis Psoriásica (APs) según criterios CASPAR (Classification Criteria for Psoriatic Arthritis)
    en el momento de la selección con implicación de las manos y/o pies con enfermedad clínica activa (más de dos articulaciones inflamadas)
    - Presentar 2 o más articulaciones con sinovitis ecográfica en la visita de screening
    - Presentar 1 o más entesis afectada ecográficamente en la visita de screening
    - Aceptar y firmar el consentimiento informado del estudio
    - Capacidad para cumplir con todas las pruebas y visitas de protocolo especificado y tener una dirección permanente.
    -Las mujeres con capacidad de gestación deben tener una prueba de embarazo negativa en la visita basal. Las mujeres con capacidad de gestación que participen en el estudio deben utilizar uno de los siguientes métodos anticonceptivos durante todo el ensayo y por lo menos hasta 28 días después de tomar la última dosis de la medicación del estudio.
    Las opciones aprobadas de anticonceptivos son:
    · Opción 1: Cualquiera de los siguientes: anticonceptivos hormonales (ej., píldoras anticonceptivas, inyección, implante, parche transdérmico, anillo vaginal); dispositivo intrauterino (DIU); ligadura de trompas; o que su pareja se haya sometido a una vasectomía
    O BIEN
    · Opción 2: preservativo masculino o femenino (un preservativo de látex o un preservativo que no sea de látex PERO QUE NO esté hecho de membrana natural [animal; ej., poliuretano]) Y uno de los siguientes métodos de barrera adicionales: a) diafragma con espermicida; b) tapón cervical con espermicida; o c) esponja anticonceptiva con espermicida
    E.4Principal exclusion criteria
    - Concomitant treatment with methotrexate or leflunomide or other DMARDs. Patients may not have taken methotrexate during the month prior to screening, leflunomide during the 2 months prior to screening and other DMARDs during the 15 days prior to screening.
    - Prior or current use of biological therapy (anti-TNF)
    -Do not meet any of the inclusion requirements.
    - Medical contraindications for taking Apremilast
    - Pregnancy or breastfeeding
    - History of allergy to any component of the study drug
    - Active tuberculosis (TB) or history of incomplete treatment for tuberculosis.
    - Substance abuse or history of substance abuse within 6 months prior to screening
    - Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks prior to screening.
    - Malignancy or history of malignancy (except in situ cutaneous carcinomas of the basal or squamous cells treated (ie, cured) and treated cervical intraepithelial neoplasms or in situ carcinoma of the cervix without evidence of recurrence within The last 5 years)
    - Use of systemic corticosteroids at doses> 10 mg / day at the time of screening and 4 weeks before
    - Use of potent enzyme inducers of cytochrome CYP3A4 (eg, rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's wort and grapefruit juice) at screening 4 weeks before or during the study
    - Use of phototherapy within 4 weeks prior to screening (ie, Ultraviolet B (UVB), psoralen and ultraviolet A (PUVA)
    - Use of any investigational drug within 4 weeks prior to screening.
    - Pre-treatment with Apremilast
    - Tratamiento concomitante con metrotrexato o leflunomida u otros DMARDs. Los pacientes no pueden haber tomado metotrexato durante el mes anterior al screening, leflunomida durante los 2 meses anteriores al screening y otros DMARDs durante los 15 días previos al screening.
    - Uso previo o actual de terapia biológica (anti-TNF)
    -No cumplir alguno de los requisitos de inclusión.
    - Contraindicaciones médicas para la toma de Apremilast
    - Embarazo o lactancia
    - Historia de alergia a algún componente del fármaco en estudio
    - Tuberculosis activa (TB) o antecedentes de tratamiento incompleto para la tuberculosis.
    - Abuso de sustancias activas o antecedentes de abuso de sustancias dentro de los 6 meses previos al screening
    - Infecciones bacterianas que requieren tratamiento con antibióticos orales o inyectables, o infecciones virales o fúngicas significativas, dentro de las 4 semanas previas al screening.
    - Malignidad o antecedentes de malignidad (excepto los carcinomas cutáneos in situ de células basales o de células escamosas tratadas [es decir, curadas] y neoplasias intraepiteliales cervicales tratadas [es decir curadas]] o carcinoma in situ del cuello uterino sin evidencia de recurrencia dentro los últimos 5 años)
    - Uso de corticosteroides sistémicos en dosis> 10 mg / día en el momento del screening y 4 semanas antes
    - Uso de inductores enzimáticos potentes del citocromo CYP3A4 (p. ej., rifampicina, fenobarbital, carbamazepina, fenitoína, hierba de San Juan y jugo de pomelo) en el momento del screening, 4 semanas antes ni durante el estudio
    - Uso de la fototerapia dentro de 4 semanas antes del screening (es decir, Ultravioleta B (UVB), psoraleno y ultravioleta A (PUVA)
    - Uso de cualquier fármaco en investigación dentro de las 4 semanas previas al screening.
    - Tratamiento previo con Apremilast
    E.5 End points
    E.5.1Primary end point(s)
    A reduction in echographic index at 12 months after the introduction of Apremilast in the study patients (12-month echographic index-baseline echographic index) / baseline echographic index
    Reducción en el índice ecográfico a 12 meses tras la introducción de Apremilast en los pacientes del estudio (Indice ecográfico 12 meses-indice ecográfico basal)/ índice ecográfico basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    - DAS 28, CDAI and SDAI indices
    - Psoriasis Activity and Severity Index (PASI)
    - Leeds Enthesitis Index (LEI).
    - Number of painful and inflamed joints assessed by (NAD and NAI or NAT)
    - Evaluation of pain using the patient EVA scale or VGP and medical EVA or VGM
    - Associated macrophage-associated nail injuries
    - Diffuse thickening or patching of the nail ventral lamina
    - Increased thickness of the nail bed
    - Índices DAS 28, CDAI y SDAI
    - Psoriasis activity and severity index (PASI)
    - Leeds Enthesitis Index (LEI).
    - Número de articulaciones dolorosas e inflamadas evaluadas mediante (NAD y NAI o NAT)
    - Evaluación del dolor mediante la escala EVA paciente o VGP y EVA médico o VGM
    - Lesiones ungueales ecograficas asociadas a la APs
    - Engrosamiento difuso o parcheado de la lámina ventral ungueal
    - Aumento del espesor del lecho ungueal
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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 Yes
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 56
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state56
    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)
    None
    Ninguno
    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 Decision2017-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-01
    P. End of Trial
    P.End of Trial StatusOngoing
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