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    Summary
    EudraCT Number:2018-001060-35
    Sponsor's Protocol Code Number:CLR_18_07
    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:2018-07-17
    Trial 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 number2018-001060-35
    A.3Full title of the trial
    A Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed studies with Tildrakizumab
    Estudio de extensión a largo plazo con dosis múltiples para demostrar la seguridad y la eficacia del tildrakizumab en sujetos con artritis psoriásica y espondilitis anquilosante o
    espondiloartritis axial no radiográfica que hayan completado previamente estudios con tildrakizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term extension study to investigate the safety and effectiveness of Tildrakizumab in patients with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed other studies with Tildrakizumab
    Estudio de extensión a largo plazo para investigar la seguridad y la efectividad del tildrakizumab en pacientes con artritis psoriásica y espondilitis anquilosante o espondiloartritis axial no radiográfica que hayan completado previamente otros estudios con tildrakizumab
    A.4.1Sponsor's protocol code numberCLR_18_07
    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 SponsorSun Pharma Global FZE
    B.1.3.4CountryUnited Arab Emirates
    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 supportSun Pharma Global FZE
    B.4.2CountryUnited Arab Emirates
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSun Pharma Advanced Research Company Limited
    B.5.2Functional name of contact pointMudgal Kothekar, MD
    B.5.3 Address:
    B.5.3.1Street Address17/B, Mahal Industrial Estate, Andheri East,
    B.5.3.2Town/ cityMumbai
    B.5.3.3Post code400093
    B.5.3.4CountryIndia
    B.5.4Telephone number+91 9632798833
    B.5.6E-mailmudgal.kothekar@sparcmail.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 nameTildrakizumab 100 mg/ml
    D.3.2Product code MK-3222
    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 INNTildrakizumab
    D.3.9.1CAS number 1326244-10-3
    D.3.9.2Current sponsor codeMK-3222
    D.3.9.3Other descriptive nameAnti-Human Interleukin-23 Monoclonal Antibody
    D.3.9.4EV Substance CodeSUB130334
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
    artritis psoriásica y espondilitis anquilosante o
    espondiloartritis axial no radiográfica
    E.1.1.1Medical condition in easily understood language
    PsA is arthritis associated with psoriasis
    AS and nr-axSpA is a type of chronic inflammatory arthritis involving the spine and/or sacroiliac joints
    PsA es una artritis asociada con psoriasis y nr-axSpA es un tipo de artritis inflamatoria crónica que afecta la columna vertebral y/o las articulaciones sacroilíacas
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    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
    Safety:
    To assess the long-term safety of tildrakizumab when administered to PsA and AS or nr-axSpA subjects by evaluation of:
    • Incidence and intensity of all AEs,
    • Changes in vital signs, laboratory assessments, electrocardiograms (ECGs), and Columbia-Suicide Severity Rating Scale (C-SSRS),
    • Immunogenicity of multiple-dose administration of tildrakizumab in these subjects.
    Efficacy:
    To assess the long-term efficacy of multiple-dose administration of tildrakizumab in subjects with PsA and AS or nr-axSpA by evaluation of:
    • PsA subjects: The proportion of subjects achieving a 20% reduction from Baseline in American College of Rheumatology response criteria (ACR20) at measured time points.
    • AS/nr-axSpA subjects: The proportion of subjects achieving Assessment of SpondyloArthritis International Society (ASAS) 40 response criteria at measured time points.
    Baseline is defined as Week 0 (Day 1) of the parent study for both ACR20 and ASAS40 response criteria.
    Seguridad:
    Evaluar la seguridad a largo plazo del tildrakizumab administrado a pacientes con artritis psoriásica (APs) y espondilitis anquilosante (EsA) o espondiloartritis axial no radiográfica (EAA-NR) mediante la evaluación de incidencia e intensidad de todos los acontecimientos adversos (AA), cambios en las constantes vitales, resultados de pruebas analíticas, electrocardiogramas (ECG) y la escala de Columbia para la evaluación del riesgo de suicidio (C-SSRS). Inmunogenia de la administración de dosis múltiples de tildrakizumab a estos sujetos.
    Eficacia: Evaluar la eficacia a largo plazo de la administración de dosis múltiples de tildrakizumab a sujetos con APs y EsA o EAA-NR mediante la evaluación de sujetos con APs: La proporción de sujetos que logren una reducción del 20 % respecto al nivel inicial según los criterios de respuesta del Colegio Estadounidense de Reumatología (ACR20) en los puntos cronológicos evaluados.
    E.2.2Secondary objectives of the trial
    To evaluate long-term treatment outcomes of tildrakizumab in adults with PsA by evaluation of:
    • ACR20, ACR50, ACR70, the components of ACR, and 36-item Short Form (SF-36) at other measured time points.
    To evaluate long-term treatment outcomes of tildrakizumab in adults with AS or nr-axSpA by evaluation of:
    • The proportion of subjects who achieve ASAS20 or ASAS40 at measured time points.
    • The proportion of subjects who achieve ASAS70 or ASAS5/6 at measured time points.
    • The 46-item tender joint counts (TJC)46 and 44-item swollen joint counts (SJC)44,
    ASAS components, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), total back pain and nocturnal pain score using a visual analog scale (VAS), and SF-36 at measured time points.
    Evaluar los resultados del tratamiento a largo plazo con tildrakizumab en adultos con APs mediante la evaluación de:
    • ACR20, ACR50, ACR70, los componentes de los criterios del ACR y el formulario breve de 36 ítems (SF-36) en otros puntos cronológicos evaluados.
    Evaluar los resultados del tratamiento a largo plazo con tildrakizumab en adultos con EsA o EAA-NR mediante la evaluación de:
    • La proporción de sujetos que cumplan los criterios ASAS20 o ASAS40 en los puntos cronológicos evaluados.
    • La proporción de sujetos que cumplan los criterios ASAS70 o ASAS5/6 en los puntos cronológicos evaluados.
    • El cuestionario de 46 ítems sobre el número de articulaciones dolorosas a la palpación (TJC46) y el cuestionario de 44 ítems sobre el número de articulaciones inflamadas (SJC44), los componentes de los criterios de la ASAS, el índice de la actividad de la enfermedad de la espondilitis anquilosante de Bath (BASDAI), el índice funcional de la espondilitis anquilosante de Bath (BASFI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects may be included in the study if they meet all of the following criteria:
    1. Subject has provided written informed consent for this long-term extension study.
    2. Subjects with PsA and AS or nr-axSpA who met the inclusion criteria of the parent studies and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 studies, with return for the EoT assessment at Week 52).
    3. PsA subjects who achieved a 20% reduction from Baseline in ACR20 response criteria at Week 52, and AS or nr-axSpA subjects who achieved ASAS40 response criteria at Week 52, AND the subject has received sufficient clinical benefit, in the opinion of the Investigator, to support continued treatment with tildrakizumab.
    This criteria using response criteria at Week 52 will apply to all subjects, including those subjects who enter the study from the wash-out phase of their parent study (after Week 52) due to the timing of study site activation of the long-term extension study.
    4. No concomitant use of both leflunomide and methotrexate,
    5. No history of active tuberculosis (TB) or symptoms of TB.
    Para poder participar en el estudio, los sujetos deben reunir todos los criterios siguientes:
    1. Haber otorgado su consentimiento informado por escrito para este estudio de extensión a largo plazo.
    2. Sujetos con APs y EsA o EAA-NR que cumplan los criterios de inclusión de los estudios originales y que hayan completado el período de tratamiento del estudio original (p. ej., hasta la semana 48 para los estudios originales de fase II, con regreso para la evaluación de FdT en la semana 52).
    3. Sujetos con APs que hayan logrado una reducción del 20 % respecto al valor inicial según los criterios de respuesta ACR20 en la semana 52, y sujetos con EsA o EAA-NR que cumplan los criterios de respuesta ASAS40 en la semana 52, Y QUE, en opinión del investigador, hayan recibido un beneficio clínico suficiente como para apoyar la opción de seguir administrando un tratamiento con tildrakizumab. Este criterio, a partir de criterios de respuesta en la semana 52, se aplicará a todos los sujetos, incluidos aquellos que entren en el estudio procedentes de la fase de reposo farmacológico de su estudio original (tras la semana 52) debido al momento de la activación de su centro del estudio para el estudio de extensión a largo plazo.
    4. Ausencia de uso concomitante de leflunomida y metotrexato.
    5. Ausencia de antecedentes de tuberculosis (TB) activa o de síntomas de TB.
    E.4Principal exclusion criteria
    Subjects should be excluded from the study if they meet any of the following criteria:
    1. New onset during the parent study of arthritic conditions other than the subject's original condition.
    2. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo-progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP.
    3. Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 16 weeks after the last dose of IMP.
    4. Subject has previously been enrolled in this long-term extension study.
    5. Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
    6. Subject has an active infection or history of infections as follows:
    − a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose of the extension study, with the last dose having been received within 7 days of start of the extension study,
    − recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this extension study to be detrimental to the subject.
    7. Major chronic inflammatory or connective tissue disease other than PsA or AS/nr axSpA (e.g., rheumatoid arthritis, systemic lupus erythematosus, Lyme disease, and gout).
    8. Known diagnosis of fibromyalgia, regional pain syndromes or active uveitis/symptomatic inflammatory bowel disease requiring therapy (AS/nr-axSpA subjects),
    9. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
    10. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study
    11. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose for this extension study.
    12. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
    13. Subject has a history of malignancy EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
    14. Subjects with a history of alcohol or drug abuse during the parent study.
    15. Significant risk of suicidality at the Baseline assessment of this extension study based on the Investigator's judgment or, if appropriate, as indicated by a response of "yes" since the last visit to question 4 or 5 in the suicidal section, or any response in the behavioral section of the C-SSRS.
    16. Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study.
    17. Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for psoriasis, PsA, and/or AS/nr-axSpA.
    General
    18. Subjects who have been placed in an institution on official or judicial orders.
    Debe excluirse del estudio a los sujetos que reúnan cualquiera de los siguientes criterios:
    1. Nueva manifestación durante el estudio original de afecciones artríticas distintas a la afección original del sujeto.
    2. Sujetos que sean mujeres con capacidad de concebir y que no acepten abstenerse de mantener relaciones heterosexuales o utilizar un método anticonceptivo doble, como por ejemplo una combinación de los siguientes: (1) anticonceptivo oral, progesterona de liberación prolongada o dispositivo intrauterino; y (2) un método de barrera (preservativo o diafragma). Los sujetos varones con parejas de sexo femenino con capacidad de concebir que no utilicen anticonceptivos de la forma anteriormente descrita deben utilizar un método anticonceptivo de barrera (por ejemplo, preservativo) si no están esterilizados quirúrgicamente (es decir, sino se han sometido a una vasectomía). Los métodos anticonceptivos deben emplearse desde el momento de la incorporación al estudio hasta 16 semanas después de la administración de la última dosis del PEI. Si un sujeto interrumpe el estudio prematuramente, el método anticonceptivo debe utilizarse hasta que hayan transcurrido 16 semanas desde la administración final del PEI.
    3. Mujeres embarazadas, en fase de lactancia o que tengan previsto quedarse embarazadas o comenzar la lactancia mientras estén participando en el estudio o durante las 16 semanas posteriores a la última dosis del PEI.
    4. Sujetos que hayan sido incluidos previamente en este estudio de extensión a largo plazo.
    5. Cualquier circunstancia que, en opinión del investigador, represente un obstáculo para la realización del estudio y/o que represente un posible riesgo inaceptable para el sujeto.
    6. Sujetos con infección activa o antecedentes de infección, que se definen de la forma siguiente:
    − una infección grave, definida como aquella que requiera la hospitalización o la administración intravenosa de agentes antinfecciosos durante las 8 semanas previas a la administración de la primera dosis del PEI del estudio de extensión, y cuya última dosis se haya recibido durante los 7 días previos al inicio del estudio de extensión;
    − infecciones crónicas o recurrentes, por ejemplo, pielonefritis crónica, osteomielitis crónica, bronquiectasia u otra infección activa que, en opinión del investigador, podría hacer que este estudio de extensión resultara perjudicial para el sujeto.
    7. Enfermedad inflamatoria o conectivopatía crónicas importantes distintas de la APs o EsA/EAA-NR (p. ej., artritis reumatoide, lupus eritematoso sistémico, borreliosis de Lyme y gota).
    8. Diagnóstico conocido de fibromialgia, síndromes de dolor regional o uveítis activa/enfermedad intestinal inflamatoria sintomática que requiera tratamiento (sujetos con EsA/EAA-NR).
    9. Sujetos con cualquier afección médica concomitante o enfermedad sistémica clínicamente significativa incontrolada (p. ej., insuficiencia renal, insuficiencia cardíaca, hipertensión, hepatopatía, diabetes o anemia) que, en opinión del investigador, pueda hacer que el tratamiento continuado resulte perjudicial para el sujeto.
    10. Sujetos con antecedentes conocidos de infección por el virus de la hepatitis B, de la hepatitis C o de la inmunodeficiencia humana durante el estudio original.
    11. Sujetos que hayan padecido infarto de miocardio, angina de pecho inestable o ictus isquémico en los 6 meses anteriores a la administración de la primera dosis del PEI para este estudio de extensión.
    12. Sujetos con neoplasia maligna activa, incluidos los indicios de carcinoma basocelular o espinocelular cutáneo o melanoma.
    13. Sujetos con antecedentes de neoplasia maligna EXCEPTO el carcinoma basocelular o espinocelular cutáneo, el carcinoma de cuello uterino localizado O el carcinoma ductal de mama localizado que se hayan tratado y se consideren curados.
    14. Sujetos con antecedentes de alcoholismo o drogadicción durante el estudio original.
    15. Riesgo significativo de suicidio durante la evaluación inicial de este estudio de extensión de acuerdo con el criterio del investigador o, si procede, indicado por una respuesta afirmativa desde la última visita a las preguntas 4 o 5 de la sección sobre suicidio, o cualquier respuesta en la sección conductual de la C-SSRS.
    16. Sujetos con necesidad de utilizar una vacuna elaborada con microbios vivos en las 10 semanas siguientes a la administración de la dosis final prevista del PEI para el estudio de extensión a largo plazo.
    17. Uso concomitante de medicamentos prohibidos o uso de tratamientos biológicos comercializados o en investigación (al margen de tildrakizumab) para la psoriasis, la APs y/o la EsA/EAA-NR.
    Generales
    18. Sujetos que hayan sido internados en una institución debido a un ordenamiento jurídico u oficial.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    For PsA subjects:
    • The proportion of subjects who achieve ACR20 at measured time points.
    • The proportion of subjects who achieve ACR50 at measured time points.
    • The proportion of subjects who achieve ACR70 at measured time points.
    • Individual components of ACR response at measured time points:
    − tender joint counts (68)
    − swollen joint counts (66)
    − PGA of disease activity (VAS)
    − Patient Global Assessment of disease activity (VAS)
    − patient's pain assessment (VAS)
    − patient's self-assessed disability (Health Assessment Questionnaire Disability Index)
    − acute-phase high sensitivity C-reactive protein (CRP)
    − erythrocyte sedimentation rate
    • SF-36 at measured time points.
    For AS or nr-axSpA subjects:
    • The proportion of subjects who achieve ASAS20 at measured time points.
    • The proportion of subjects who achieve ASAS40 at measured time points.
    • The proportion of subjects who achieve ASAS70 at measured time points.
    • The proportion of subjects who achieve an ASAS5/6 response at measured time points.
    ASAS5/6 response is defined as a 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [average i.e., mean score of Questions 5 and 6 of the BASDAI], spinal mobility [Bath Ankylosing Spondylitis Metrology Index [BASMI], and acute-phase reactants [CRP]).
    • Individual ASAS components at measured time points:
    − PtGA of disease activity (VAS in mm),
    − total back pain (VAS in mm),
    − BASFI (VAS in mm),
    − inflammation (mean score of questions 5 and 6 of BASDAI) (VAS in mm).
    • BASDAI at measured time points.
    • VAS (total back pain and nocturnal pain score) at measured time points.
    • BASMI at measured time points.
    • TJC46 and SJC44 at measured time points
    • SF-36 at measured time points.
    Eficacia:
    Para sujetos con APs:
    • La proporción de sujetos que obtienen una respuesta ACR20 en los puntos cronológicos evaluados.
    • La proporción de sujetos que obtienen una respuesta ACR50 en los puntos cronológicos evaluados.
    • La proporción de sujetos que obtienen una respuesta ACR70 en los puntos cronológicos evaluados.
    • Componentes individuales de la respuesta ACR en los puntos cronológicos evaluados:
    − número de articulaciones dolorosas a la palpación (68)
    − número de articulaciones inflamadas (66)
    − evaluación global del médico (EGM) de la actividad de la enfermedad (EVA)
    − evaluación global de la actividad de la enfermedad por parte del paciente (EVA)
    − evaluación del dolor realizada por el paciente (EVA)
    − discapacidad autoevaluada por el paciente (índice de discapacidad del cuestionario de evaluación de la salud)
    − sensibilidad elevada a la proteína C-reactiva (PCR) en fase aguda
    − velocidad de eritrosedimentación
    • SF-36 en los puntos cronológicos evaluados.
    Para sujetos con EsA o EAA-NR:
    • La proporción de sujetos que obtienen una respuesta ASAS20 en los puntos cronológicos evaluados.
    • La proporción de sujetos que obtienen una respuesta ASAS40 en los puntos cronológicos evaluados.
    • La proporción de sujetos que obtienen una respuesta ASAS70 en los puntos cronológicos evaluados.
    • La proporción de sujetos que obtienen una respuesta ASAS5/6 en los puntos cronológicos evaluados.
    La respuesta ASAS5/6 se define como una mejora del 20 % en 5 de 6 dominios (función física [BASFI], dorsalgia total, evaluación global de la actividad de la enfermedad por parte del paciente, inflamación [promedio, es decir, puntuación media de las preguntas 5 y 6 del BASDAI], movilidad espinal [índice de metrología de Bath para la espondilitis anquilosante o BASMI] y reactantes en fase aguda [PCR]).
    • Componentes individuales de la ASAS en los puntos cronológicos evaluados:
    − evaluación global del paciente (EGP) de la actividad de la enfermedad (EVA en mm)
    − dorsalgia total (EVA en mm)
    − BASFI (EVA en mm)
    − inflamación (puntuación media de las preguntas 5 y 6 del BASDAI) (EVA en mm)
    • BASDAI en los puntos cronológicos evaluados.
    • EVA (puntuación de dorsalgia total y de dolor nocturno) en los puntos cronológicos evaluados.
    • BASMI en los puntos cronológicos evaluados.
    • TJC46 y SJC44 en los puntos cronológicos evaluados.
    • SF-36 en los puntos cronológicos evaluados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Assessments in the protocol (Table 9-1 and 9-2)
    Consulte el Calendario de evaluaciones en el protocolo (Tablas 9-1 y 9-2).
    E.5.2Secondary end point(s)
    Pharmacokinetics: Serum tildrakizumab concentration data.
    Safety: The following data will be collected for assessment of safety:
    • AEs.
    • Laboratory assessments.
    • Suicidal ideation and behavior (C-SSRS).
    • Vital signs.
    • Electrocardiogram.
    • Physical examination.
    • ADA to tildrakizumab
    Farmacocinética: Datos de la concentración sérica de tildrakizumab.
    Seguridad: Se recopilarán los siguientes datos para evaluar la seguridad:
    • AA
    • Pruebas analíticas
    • Pensamientos y conducta suicidas (C-SSRS)
    • Constantes vitales
    • Electrocardiograma
    • Exploración física
    • AAF contra el tildrakizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Assessments in the protocol (Table 9-1 and 9-2)
    Consulte el Calendario de evaluaciones en el protocolo (Tablas 9-1 y 9-2).
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Argentina
    Hungary
    Mexico
    Poland
    Russian Federation
    Spain
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    End of study is defined as the last visit of the 4-year treatment period (Week 208, EoT/Follow-up) for the last global subject.
    Si es la última visita del último paciente, introduzca “UVUP”. Si no es la UVUP, proporcione la definición: El fin del estudio se define como la última visita del período de tratamiento de 4 años (semana 208, FdT/Seguimiento) del último sujeto a nivel mundial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    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: 540
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 540
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-30
    P. End of Trial
    P.End of Trial StatusOngoing
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