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    Summary
    EudraCT Number:2013-004781-34
    Sponsor's Protocol Code Number:W13-984
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-25
    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 number2013-004781-34
    A.3Full title of the trial
    Rapidity of onset of response to Adalimumab in luminal Crohn's disease. RAPIDA study.
    Rapidez en el inicio de la respuesta a Adalimumab en pacientes con enfermedad de Crohn luminal. Estudio Rápida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rapidity of response to adalimumab treatment in patients with Crohn´s Disease.
    Rapidez en la respuesta al tratamiento con Adalimumab en pacientes con Enfermedad de Crohn.
    A.4.1Sponsor's protocol code numberW13-984
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbVie Farmacéutica S.L.U.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbbVie Farmacéutica S.L.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbvie Farmacéutica S.L.U.
    B.5.2Functional name of contact pointInvestigación Clinica
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Burgos 91
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28050
    B.5.3.4CountrySpain
    B.5.4Telephone number0034901 20 01 03
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Humira 40 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation 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.3.1Product nameADALIMUMAB
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease
    Enfermedad de Crohn.
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    Enfermedad de Crohn.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 evaluate the rapidity of onset of clinical response to adalimumab therapy in patients with luminal Crohn's disease
    Evaluar la rapidez del inicio de la respuesta clínica al tratamiento con Adalimumab en pacientes con enfermedad de Crohn luminal.
    E.2.2Secondary objectives of the trial
    ?To evaluate the improvement of health-related quality of life and fatigue to adalimumab therapy in patients with Crohn's disease
    ? To evaluate the improvement in analytic and fecal markers of inflammation in patients with Crohn's disease treated with adalimumab in the short term
    ? To evaluate the correlation of a rapid response at day 4 and week 1 with remission at week 12
    ? Evaluar la mejoría de la calidad de vida relacionada con la salud y la fatiga en pacientes con enfermedad de Crohn tratados con Adalimumab.
    ? Evaluar la mejoría de los marcadores analíticos y fecales de inflamación en pacientes con enfermedad de Crohn tratados con Adalimumab a corto plazo.
    ? Evaluar la correlación de una respuesta rápida en el día 4 y la semana 1 con la remisión en la semana 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Crohn?s disease diagnosed within, at least, the previous 4 months.
    2. Patients with active luminal (Harvey-Bradshaw Index ?8) moderate-to-severe Crohn´s disease.
    3. Adult patient 18-75 year-old.
    4. No response to a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant.
    5. If receiving any of the following treatments, their dose should be stable during the periods indicated:
    ? Aminosalicylates for, at least, the last 4 weeks
    ? Probiotics for, at least, the last 4 weeks
    ? Analgesics for, at least, the last 4 weeks
    ? Antidiarrheals for, at least, the last 4 weeks
    ? Oral budesonide (maximum dose of 9 mg/day) for, at least, the last 2 weeks
    ? Oral prednisone or equivalent for, at least, the last 2 weeks
    ? CD-related antibiotics for, at least, the last 4 weeks
    ? Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks
    1. Enfermedad de Crohn diagnosticada por lo menos en los 4 meses anteriores.
    2. Enfermedad de Crohn luminal activa (índice de Harvey-Bradshaw ?8) de moderada a grave.
    3. Adulto de 18-75 años.
    4. Sin respuesta a un tratamiento completo y adecuado de corticosteroides, inmunosupresores o ambos.
    5. Si recibe cualquiera de los tratamientos siguientes, la dosis debe haberse mantenido estable durante los periodos que se señalan:
    ? Aminosalicilatos durante, como mínimo, las últimas 4 semanas
    ? Probióticos durante, como mínimo, las últimas 4 semanas
    ? Analgésicos durante, como mínimo, las últimas 4 semanas
    ? Antidiarreicos durante, como mínimo, las últimas 4 semanas
    ? Budesonida oral (dosis máxima de 9 mg/día) durante, como mínimo, las últimas 2 semanas
    ? Prednisona oral o equivalente durante, como mínimo, las últimas 2 semanas
    ? Antibióticos utilizados por la enfermedad de Crohn durante, como mínimo, las últimas 4 semanas
    ? Azatioprina, 6-mercaptopurina o metotrexato durante, como mínimo, las últimas 12 semanas
    E.4Principal exclusion criteria
    1. Previous treatment with any anti-TNF agent.
    2. Surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (> 100 cm), short bowel syndrome.
    3. Fistulising Crohn's disease.
    4. Treatment with cyclosporine or tacrolimus within the previous 8 weeks.
    5. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria (NYHA Functional Classification).
    6. Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
    7. Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis.
    8. Screening laboratory values (according to central laboratory)
    9. Known of hepatitis C (HC) infection.
    10. Serologic evidence of hepatitis B (HB) infection* based on the results of testing for HBsAg, anti-HBc and anti-HBs antibodies as follows:
    1. Tratamiento previo con cualquier fármaco anti-TNF.
    2. Resección quirúrgica intestinal en los 6 meses anteriores, ostomía, resección intestinal amplia (>100 cm), síndrome del intestino corto.
    3. Enfermedad de Crohn fistulizante.
    4. Tratamiento con ciclosporina o tacrolimús en el plazo de las 8 semanas anteriores.
    5. Cardiopatía clínicamente importante, como angina inestable, infarto agudo de miocardio en el plazo de los 6 meses anteriores a la selección, insuficiencia cardiaca congestiva de clase de la NYHA peor que grado II (clasificación funcional de la New York Heart Association)
    6. Ostomía o reservorio ileoanal (no se excluye a los pacientes con anastomosis ileorrectal previa).
    7. Proctocolectomía, colectomía total, ileostomía, estoma o reservorio ileal con anastomosis anal.
    8. Resultados analíticos en la selección (según el laboratorio central)
    9. Diagnóstico de hepatitis C (HC).
    10. Signos serológicos de hepatitis B (HB)* a juzgar por los siguientes resultados de las pruebas de HbsAg, anticuerpos anti-HBc y anti-HBs
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with clinical response at day 4. Clinical response is defined as a decrease of at least 3 points in the Harvey-Bradshaw Index, at day 4
    Porcentaje de pacientes con respuesta clínica en el día 4. Se define como respuesta clínica la disminución de un mínimo de 3 puntos en el índice de Harvey-Bradshaw, en el día 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 4
    Día 4
    E.5.2Secondary end point(s)
    ?Proportion of patients with clinical response at week 1. Clinical response is defined as a decrease of at least 3 points in the Harvey-Bradshaw Index, at week 1
    ?Proportion of patients with clinical remission at weeks 2 and 4 (Harvey-Bradshaw Index <5)
    ?Change in Quality of Life, assessed with the EQ-5D and IBDQ36 questionnaires from baseline to week 12
    ? Change in Fatigue, assessed through the Fatigue Impact Scale for Daily Use (D-FIS), from baseline to week 12
    ?Change in analytic markers of inflammation from baseline to week 12: hemogram, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin and coagulation (including fibrinogen)
    ?Statistical analysis will be performed to evaluate the correlation between a clinical response at day 4 and week 1 with remission at week 12
    ? Porcentaje de pacientes con respuesta clínica en la semana 1. Se define como respuesta clínica la disminución de un mínimo de 3 puntos en el índice de Harvey-Bradshaw, en la semana 1.
    ? Porcentaje de pacientes con remisión clínica en las semanas 2 y 4 (índice de Harvey-Bradshaw <5).
    ? Cambio de la calidad de vida, evaluada mediante los cuestionarios EQ-5D e IBDQ 36, entre el momento basal y la semana 12.
    ? Cambio de la fatiga, evaluada mediante la escala de impacto de la fatiga para uso diario (D-FIS, Fatigue Impact Scale for Daily Use), entre el momento basal y la semana 12.
    ? Cambio de los marcadores analíticos de inflamación entre el momento basal y la semana 12: hemograma, velocidad de sedimentación globular (VSG), proteína C reactiva (PCR), calprotectina fecal y coagulación (con fibrinógeno).
    ? Se realizará un análisis estadístico para evaluar la correlación de una respuesta clínica en el día 4 y la semana 1 con la remisión en la semana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 1, 2, 4 and 12
    Semana 1, 2, 4 y 12
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned20
    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
    The end-of-study is defined as the date of the last subject's last visit
    La finalización del estudio se define como la fecha de la 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 months12
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state98
    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)
    As per protocol: Will be able to receive commercial Humira® therapy after the end of study participation, if applicable.
    Por protocolo: Podrán recibir tratamiento con Humira® comercial después de finalizar la participación en el estudio, si procede.
    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 Decision2014-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-23
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