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    Summary
    EudraCT Number:2016-001593-15
    Sponsor's Protocol Code Number:B15-884
    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:2016-08-23
    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 number2016-001593-15
    A.3Full title of the trial
    A Multi-center, Randomized, Double blind, Prospective Study to Evaluate the Efficacy and Safety of high induction doses of adalimumab in moderate to severe psoriasis patients. The DEEP study.
    Estudio Multicéntrico, Aleatorizado, Doble ciego Prospectivo para Evaluar la Eficacia y Seguridad de Dosis de Inducción Alta de Adalimumab en Pacientes con Psoriasis de Moderada a Severa. Estudio DEEP.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of high induction doses of adalimumab in moderate to severe psoriasis patients.
    Estudio para Evaluar la Eficacia y Seguridad de Dosis de Inducción Alta de Adalimumab en Pacientes con Psoriasis de Moderada a Severa.
    A.3.2Name or abbreviated title of the trial where available
    The DEEP study
    Estudio DEEP
    A.4.1Sponsor's protocol code numberB15-884
    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 SponsorInstitut de Recerca de l’Hospital de la Santa Creu i Sant Pau
    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 supportAbbVie Spain S.L.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street Addressc/ Sant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935537636
    B.5.5Fax number0034935537812
    B.5.6E-mailuicec@santpau.cat
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 in pre-filled pen
    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.3.9.2Current sponsor codeAbbVie Ltd.
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 160
    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 AuthorisationSpain
    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 in pre-filled pen
    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.3.9.2Current sponsor codeAbbVie Ltd.
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 80
    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 pen
    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
    Moderate to severe chronic plaque psoriasis
    Psoriasis en placas de moderada a severa
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasis
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of adalimumab when administered at doses of 160 mg at week 0 followed by 40 mg at Week 1 and then 40mg every other week from week 3 until week 15 vs placebo 80 mg and adalimumab 80mg at Week 0 and then adalimumab 40mg every other week from Week 1 until week 15 included, in the treatment of patients with moderate to severe plaque-type psoriasis at 12 weeks.
    Evaluar la eficacia de adalimumab cuando se administra una dosis de adalimumab de 160 mg en la semana 0 seguida de 40 mg en semanas alternas desde la semana 1 hasta la semana 15 incluida vs 80 mg de placebo y 80 mg de adalimumab en la semana 0 y 40 mg de adalimumab en semanas alternas desde la semana 1 hasta la semana 15 incluida en el tratamiento de pacientes con psoriasis en placas moderada-grave a las 12 semanas.
    E.2.2Secondary objectives of the trial
    • Evaluate the efficacy of adalimumab when administered at doses of 160 mg at week 0 followed by 40 mg at Week 1 and then 40mg every other week from week 3 until week 15 vs placebo 80 mg and adalimumab 80mg at Week 0 and then adalimumab 40mg every other week from Week 1 until week 15 included, in the treatment of patients with moderate to severe plaque-type psoriasis at 4 and 16 weeks.
    • Evaluate HRQoL at 4, 12 and 16 weeks.
    • Evaluate safety, and tolerability.
    • Evaluar la eficacia de adalimumab cuando se administra una dosis de adalimumab de 160 mg en la semana 0 seguida de 40 mg en semanas alternas desde la semana 1 hasta la semana 15 incluida vs 80 mg de placebo y 80 mg de adalimumab en la semana 0 y 40 mg de adalimumab en semanas alternas desde la semana 1 hasta la semana 15 incluida en el tratamiento de pacientes con psoriasis en placas moderada-grave a las semanas 4 y 16.
    • Evaluar la calidad de vida relacionada con la salud (CVRS) a las semanas 4, 12 y 16.
    • Evaluar la seguridad y tolerabilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged ≥ 18 years.

    2. Patients with moderate-to-severe chronic plaque psoriasis.

    3. Subject has a diagnosis of chronic plaque psoriasis as determined by
    subject medical history and confirmation of diagnosis through physical examination by the Investigator, with disease duration of at least 6 months since diagnosis. Subjects with concomitant hand, feet, scalp or nail psoriasis will be permitted into this study.

    4. PASI score ≥ 12 and/or BSA≥10.

    5. Investigator Global Assessment (IGA) mod 2011 score ≥ 3 (based on a scale of 0 - 4).

    6. Patients who are candidates for systemic therapy.

    7. Disease inadequately controlled by phototherapy or previous systemic therapy or by 1 approved biological therapy.
    8. Methotrexate therapy (≤25 mg/week) allowed if the dose was stable for at least 4 weeks before baseline visit.

    9. Subject has a negative TB Screening Assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 2 weeks of an ongoing TB prophylaxis or have documented completion of a full course of TB prophylaxis, prior to Baseline.

    10. If female, must meet one of the following criteria:

    If female subject, is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for at least 28 days after last dose of study drug.

    Examples of approved methods of birth control include the following:

    • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
    • Hormonal contraceptives for 90 days prior to study drug administration;
    • A vasectomized partner.

    11. Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening (For subjects with a normal CXR or ECG taken within 90 days of Screening, a repeat CXR or ECG at Screening will not be required, provided all protocol required documentation is available at the site).

    12. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

    13. Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.
    1. Pacientes hombres y mujeres con edad ≥ 18 años.

    2. Pacientes con psoriasis en placas crónica de moderada a severa.

    3. El sujeto presenta un diagnóstico de psoriasis en placas crónica especificado en la historia clínica y la confirmación del diagnóstico mediante exploración física por el investigador, con una duración de la enfermedad de al menos 6 meses desde el diagnóstico. Los sujetos con psoriasis concomitante en manos, pies, cuero cabelludo o uñas podrán participar en el estudio.

    4. Puntuación PASI ≥ 12 y/o BSA≥ 10.

    5. Puntuación de la evaluación global realizada por el investigador (IGA) mod 2011 ≥ 3 (basada en una escala de 0 - 4).

    6. Pacientes candidatos a terapia sistémica.

    7. Enfermedad controlada de manera inadecuada con fototerapia o terapia sistémica previa o por una terapia biológica previa aprobada.

    8. Terapia concomitante con metotrexato (≤25 mg/week) permitida si la dosis permanece estable durante al menos 4 semanas antes de la visita basal.

    9. El sujeto tiene un cribado de TB negativo. Si el paciente tiene evidencia de una infección latente de TB deberá iniciar y completar un mínimo de 2 semanas de profilaxis continua o haber documentado el haber completado una profilaxis completa de TB antes de la visita basal.

    10. Si el sujeto es mujer, debe cumplir uno de los siguientes criterios:

    Si el sujeto es mujer, o bien no tiene posibilidad de concebir, definido como postmenopáusica desde hace al menos un año o con esterilización quirúrgica (ligadura de trompas bilateral, ooforectomía y/o histerectomía) o si tiene posibilidad de concebir está utilizando un método anticonceptivo aprobado durante el estudio y al menos 28 días después de la última dosis del fármaco en estudio.

    Ejemplos de métodos anticonceptivos aprobados:

    • Preservativos, esponja, espumas, geles, diafragma o dispositivo intrauterino (DIU);
    • Terapia anticonceptiva hormonal durante al menos 90 días previos a la administración del fármaco en estudio;
    • Pareja vasectomizada.

    11. El sujeto a criterio del investigador principal se encuentra en buen estado de salud basado en los resultados de la historia médica, perfil de laboratorio, examen físico, radiografía de tórax (RxT), y un ECG de 12 derivaciones realizado durante la selección.

    12. Los sujetos deben estar dispuestos a dar su consentimiento informado por escrito y cumplir con los requerimientos del protocolo de estudio.

    13. Los sujetos tienen que estar dispuestos y ser capaces de autoadministrarse inyecciones SC o disponer de una persona cualificada que le administre inyecciones SC.
    E.4Principal exclusion criteria
    1. Psoriasis other than chronic plaque-type.

    2. Diagnosis of other active skin diseases or skin infections.

    3. Known hypersensitivity to adalimumab or its excipients.

    4. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.

    5. History of invasive infection (e.g. listeriosis and histoplasmosis), human immunodeficiency virus (HIV).

    6. Subjects with any active viral infection that based on the investigator’s clinical assessment makes the subject an unsuitable candidate for the study.

    7. Hepatitis B: HBs Ag positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBs Ab positive subjects. (See section 5.3.1.1.15)

    8. Chronic recurring infections or active TB.

    9. Evidence of dysplasia or malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.

    10. History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which would put the subject at risk by participation in the study.

    11. Clinically significant abnormal screening laboratory results as evaluated by the Investigator.

    12. Prior exposure to biologics that have a potential or known association with PML (progressive multifocal leukoencephalopathy) i.e., natalizumab (Tysabri®), or rituximab (Rituxan®).

    13. Ongoing use of topical therapy at baseline visit.

    14. Ongoing use of systemic therapy (Cyclosporine, retinoids and fumaric acid esters) or UVA or UVB phototherapy including PUVA at baseline visit.

    15. Ongoing use of biological therapy at baseline visit.

    16. Current treatment with any investigational drug of chemical or biologic nature or within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Baseline visit.

    17. Received topical psoriasis therapy (e.g., keratolytics, coal tar, anthralin, etc.) within 2 weeks of the Baseline visit.

    18. Subject has been treated with systemic corticosteroids (oral or parenteral) 4 weeks (28 days) or topical corticosteroids 2 weeks (14 days) prior to Baseline. Inhaled corticosteroids for stable medical conditions are allowed.

    19. Received UVA or UVB phototherapy including PUVA or used a tanning booth 4 weeks prior to the Baseline visit.

    20. Cyclosporine, retinoids and fumaric acid esters, must be washed out for at least 4 weeks before the baseline visit.

    21. Ongoing Methotrexate treatment if >25 mg/week or unstable 4 weeks before baseline visit.

    22. Subject may have prior exposure to JAK inhibitors as long as they have been off therapy for at least 5 half-lives

    23. Subject may have prior exposure to PDE4 inhibitors as long as they have been off therapy for at least 5 half-lives (45h).

    24. Prior exposure to adalimumab.

    25. Failure of more than 1 prior approved biological therapies.

    26. Prior exposure to any TNF inhibitors within 5 half-lives of the screening visit:
    - Etanercept received < 3 weeks (21 days) before Baseline
    - Infliximab received < 8 weeks (56 days) before Baseline

    27. Prior exposure to any IL-17 inhibiting biological therapy and/or IL12/23 or IL-23 inhibitors within 5 half-lives of the screening visit:
    - IL-17 received < 9 weeks (67 days)
    - IL 12/23 received < 15 weeks (85 days)

    28. Receipt of any live vaccine within 1 month prior to the Screening visit, or will require vaccination during the study participation including up to 70 days after the last dose of study drug.

    29. Positive pregnancy test at Screening or Baseline.

    30. Female subjects who are breast-feeding or considering becoming pregnant during the study.

    31. History of clinically significant drug or alcohol abuse in the last 12 months.

    32. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive adalimumab or subject has any contraindication to adalimumab, according to local label.
    1. Psoriasis de otro tipo distinto al tipo en placas.

    2. Diagnóstico de otras enfermedades o infecciones activas en la piel.

    3. Hipersensibilidad conocida o adalimumab o sus excipientes.

    4. Historia de enfermedad desmielinizante (incluyendo mielitis) o síntomas neurológicos sugestivos de enfermedad desmielinizante.

    5. Historia de enfermedad invasiva (p.ej. listeriosis e histoplasmosis), o virus de la inmunodeficiencia humana (VIH).

    6. Sujetos con cualquier enfermedad vírica que basada en la evaluación clínica del IP convierta al sujeto en no candidato al estudio.

    7. Hepatitis B: Ag HBs (+) o sensibilidad detectada en el test cualitativo de la RCP del ADN-VHBr para sujetos positivos al Ac HBc/Ac HBs. (Ver sección 5.3.1.1.15)

    8. Infecciones crónicas recurrentes o activas de TB.

    9. Evidencia de displasia o neoplasia maligna (incluyendo linfoma y leucemia) distintas del carcinoma de células basales o escamosas cutáneas no metastásico y/o carcinoma in situ de cérvix.

    10. Historia de fallo cardiaco congestivo moderado a severo (clase III o IV según la NYHA), accidente cerebrovascular reciente y cualquier otra condición que ponga al sujeto en riesgo por su participación en el estudio.

    11. Resultado de las pruebas de laboratorio de selección clínicamente anómalas según la evaluación del IP.

    12. Exposición previa a biológicos con asociación conocida o potencial a leucoencefalopatía multifocal progresiva (p. ej., natalizumab (Tysabri®), o rituximab (Rituxan®).

    13. Sujeto en tratamiento con terapia tópica en la visita basal.

    14. Sujeto en tratamiento con terapia sistémica (ciclosporina, retinoides y estéres del ácido fumárico) o fototerapia con UVB o UVA incluyendo PUVA en la visita basal.

    15. Sujeto en tratamiento con terapia biológica en la visita basal.

    16. Tratamiento actual con cualquier fármaco en investigación de naturaleza química o biológica o dentro de un periodo mínimo de 30 días o 5 vidas medias (cualquiera que sea más largo) del fármaco previo a la visita basal.

    17. Recibir terapia tópica para la psoriasis (p. ej., queratolíticos, alquitrán de hulla, antralinaetc.) dentro de 2 semanas desde la visita basal

    18. Sujetos que hayan sido tratados con corticosteroides sistémicos (oral o parenteral) 4 semanas (28 días) o corticosteroides tópicos 2 semanas (14 días) previos a la visita basal. Los corticosteroides inhalados para las condiciones médicas estables están permitidos.

    19. Haber recibido fototerapia con UVA o UVB incluyendo PUVA o haber usado una cabina de bronceado 4 semanas antes de la visita basal.

    20. Los pacientes tratados previamente con ciclosporina, retinoides, y ésteres del ácido fumárico, deberán tener un periodo de lavado de al menos 4 semanas antes de la visita basal.

    21. Tratamiento continuado con Metotrexate>25mg/semana o inestable 4 semanas antes de la visita basal.

    22. Los sujetos con exposición previa a inhibidores JAK siempre y cuando hayan estado sin terapia durante al menos 5 vidas medias.

    23. Los sujetos con exposición previa a inhibidores PDE4 siempre y cuando hayan estado sin terapia durante al menos 5 vidas medias (45h).

    24. Exposición previa a adalimumab.

    25. Fallo de una o más terapias biológicas aprobadas previas.

    26. Exposición previa a cualquiera de los inhibidores TNF dentro de las 5 vidas medias previas a la visita basal:

    • Etanercept < 3 semanas (21 días) antes de la visita basal
    • Infliximab < 8 semanas (56 días) antes de la visita basal

    27. Exposición previa a cualquier inhibidor IL-17 y/o IL12/23 o inhibidores IL-23 dentro de las 5 vidas medias de la visita de selección.
    • IL-17 < 9 semanas (67 días) antes de la visita basal
    • IL 12/23 < 15 semanas (85 días) antes de la visita basal

    28. Haber recibido cualquier vacuna viva en el plazo de 1 mes previo a la visita de selección, o que requerirá una vacuna durante su participación en el estudio incluyendo hasta 70 días después de la última dosis de estudio.

    29. Test positivo de embarazo en las visitas de selección y basal.

    30. Mujeres que se encuentren en periodo de lactancia o considerando quedarse embarazadas durante el estudio.

    31. Historia de abusos de drogas o alcohol clínicamente relevante en los últimos 12 meses.

    32. Consideración por el IP, por cualquier razón, que el sujeto no es un candidato a participar y recibir adalimumab o el sujeto presenta cualquier contraindicación, de acuerdo con la ficha técnica.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving PASI 90 response at week 12.
    Porcentaje de pacientes con PASI 90 en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    • The percentage of patients achieving PASI 90 at 4 and 16 weeks.
    • The percentage of patients achieving PASI 50, PASI 75 and PASI 100 at 4, 12 and 16 weeks.
    • Percentage of patients achieving PASI ≤3 at 4, 12, and 16 weeks.
    • The percentage of patients achieving an IGA of clear or almost clear (0/1) at weeks 4, 12 and 16.
    • The percentage of patients with Dermatology Quality Index (DLQI) of 0 or 1 at weeks 4, 12 and 16.
    • Pruritus and Pain percentage of change from baseline at weeks 4, 12 and 16.
    • DLQI percentage of change from baseline at weeks 4, 12 and 16.
    • Treatment-emergent adverse events, defined as events with an onset date after the first study drug until 70 days following the last study drug administration.
    • Porcentaje de pacientes con PASI 90 en las semanas 4 y 16.
    • Porcentaje de pacientes con PASI 50, PASI 75 y PASI 100 en las semanas 4, 12 y 16.
    • Porcentaje de pacientes con una puntuación PASI absoluta de ≤ 3 en las semanas 4, 12 y 16.
    • Porcentaje de pacientes con puntuación PGA mod 2011 de 0 o 1 (blanqueado o casi blanqueado), en las semanas 4, 12 y 16.
    • Porcentaje de cambio en el picor o dolor desde la visita basal hasta las semanas 4, 12 y 16.
    • Porcentaje de pacientes con puntuación DLQI, de 0 o 1, en las semanas 4, 12 y 16.
    • Cambio desde la visita basal en la puntuación DLQI, en las semanas 4, 12 y 16.
    • Acontecimientos adversos, los acontecimientos adversos graves y los acontecimientos adversos emergentes del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, 12 and 16.
    Safety after the first study drug until 70 days following the last study drug administration.
    Semana 4, 12 y 16.
    Evaluación de la seguridad desde la primera administración del medicamento en investigación hasta 70 días tras la última administración.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dosis recomendada de Humira para pacientes adultos con psoriasis
    Recommended dose of Humira for adult patients with psoriasis
    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 concerned41
    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
    Last Visit Last Subject
    Última visita del último paciente
    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 months10
    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: 368
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 368
    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 state368
    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)
    Expected normal treatment.
    Tratamiento clínico habitual.
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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