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    Summary
    EudraCT Number:2010-022383-12
    Sponsor's Protocol Code Number:CCX114157
    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:2012-01-11
    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 number2010-022383-12
    A.3Full title of the trial
    A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease
    Estudio aleatorizado, doble-ciego, controlado con placebo y de 52 semanas de duración para evaluar la eficacia y seguridad de GSK1605786A en el mantenimiento de la remisión en pacientes con Enfermedad de Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease
    Un estudio de 52 semanas aleatorizado, doble ciego, controlado con placebo para investigar la eficacia y la seguridad de GSK1605786A en el mantenimiento de la remisión en sujetos con Enfermedad de Crohn.
    A.4.1Sponsor's protocol code numberCCX114157
    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 SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 44 66
    B.5.5Fax number+44208990 12 34
    B.5.6E-mailGSKClincialSupportHD@gsk.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 nameGSK1605786A
    D.3.2Product code GSK1605786A
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeGSK1605786A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with Crohn's Disease
    Pacientes con enfermedad de Crohn.
    E.1.1.1Medical condition in easily understood language
    Crohn's disease Inflammatory bowel disease
    Enfermedad de Crohn, enfermedad inflamatoria intestinal.
    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 14.1
    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 assess the efficacy of GSK1605786A compared with placebo in maintaining
    clinical remission in subjects with Crohn's disease over 52 weeks.
    - Evaluar la eficacia de GSK1605786A en comparación con placebo en el mantenimiento de la remisión clínica en pacientes con enfermedad de Crohn durante 52 semanas.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of GSK1605786A compared with placebo
    - To investigate the effect of GSK1605786A compared with placebo on health-related quality of life
    - To investigate the effect of GSK1605786A compared with placebo on health-related resource utilisation
    - To investigate the effect of GSK1605786A compared with placebo on work productivity and activity impairment
    - To investigate the effect of GSK1605786A compared with placebo on unemployment and disability rates
    - To investigate the effect of GSK1605786A compared with placebo on biomarkers of inflammation [C-reactive protein (CRP) and faecal calprotectin]
    - To explore the dose relationships between GSK1605786A plasma concentration and Clinical response endpoints
    - To explore potential relationships between genetic variants and GSK1605786A efficacy and safety endpoints.
    - Evaluar la seguridad de GSK1605786A en comparación con placebo.
    - Investigar el efecto de GSK1605786A en comparación con placebo sobre la calidad de vida relacionada con la salud.
    - Investigar el efecto de GSK1605786A en comparación con placebo sobre la utilización de recursos sanitarios.
    - Investigar el efecto de GSK1605786A en comparación con placebo sobre el deterioro de la productividad laboral y la actividad.
    - Investigar el efecto de GSK1605786A en comparación con placebo sobre las tasas de desempleo y discapacidad.
    - Investigar el efecto de GSK1605786A en comparación con un placebo sobre biomarcadores de la inflamación [proteína C reactiva (PCR) y calprotectina fecal].
    - Investigar las relaciones con la dosis entre la concentración plasmática de GSK1605786A y los criterios de valoración de la respuesta clínica.
    - Investigar posibles relaciones entre variantes genéticas y los criterios de valoración de la eficacia y seguridad de GSK1605786A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects achieving clinical response (CDAI decrease >= 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151 or Study CCX114643
    2. Written informed consent prior to any CCX114157 specific study procedures.
    3.Females of child-bearing potential (FCBP) must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following:
    Contraceptive Methods with a Failure Rate of < 1%
    - Abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle
    - Oral contraceptive, either combined or progestogen alone
    - Injectable progestogen
    - Implants of etonogestrel or levonorgestrel
    - Estrogenic vaginal ring
    - Percutaneous contraceptive patches
    - Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1%
    failure rate as stated in the product label
    - Male partner sterilization prior to the female subject's entry into the study,
    and this male is the sole partner for that subject. The information on the male
    sterility can come from the site personnel's: review of subject's medical
    records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history.
    - Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository)
    - Male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)
    These allowed methods of contraception are only effective when used consistently,
    correctly and in accordance with the product label. The Investigator is responsible for
    ensuring subjects understand how to properly use these methods of contraception. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle.
    Female subjects should not be enrolled if they are pregnant or lactating or if they plan to become pregnant during the time of study participation. For women of child-bearing potential, a urine pregnancy test will be performed at repeated intervals throughout the study and at the Early Withdrawal or Follow-up visits if applicable.
    4. Any medications being currently received for Crohn's disease must remain stable throughout the study period with the exception of tapering of corticosteroids and dose
    reductions of immunosuppressants for the management of drug toxicity. See Study Procedures Manual.
    5. Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose tapering.
    Note: Country-specific requirement for French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    1. Pacientes que logren una respuesta clínica (disminución del CDAI >= 100 puntos) o la remisión (CDAI <150) una vez finalizado el tratamiento en el estudio CCX114151 o el estudio CCX114643.
    2. Consentimiento informado por escrito antes de realizar ningún procedimiento específico del estudio CCX114157.
    3. Las mujeres en edad fértil (MEF) deben permanecer sexualmente inactivas o comprometerse a utilizar métodos anticonceptivos con una tasa de fracasos <1 % al año cuando se utilizan de forma sistemática y correcta y, en su caso, de acuerdo con la ficha técnica del producto, durante todo este estudio según se define a continuación:
    Métodos anticonceptivos con una tasa de fracasos <1 %
    - Abstinencia de relaciones con penetración vaginal, cuando sea el hábito preferido y habitual de la mujer.
    - Anticonceptivo oral, ya sea combinado o con progesterona sola.
    - Progestágeno inyectable.
    - Implantes de etonogestrel o levonorgestrel.
    - Anillo vaginal estrogénico.
    - Parches anticonceptivos percutáneos.
    - Dispositivo intrauterino (DIU) o sistema intrauterino (SIU) que cumpla la tasa de fracasos <1 % según se describe en la ficha técnica.
    - Esterilización de la pareja masculina antes de la incorporación de la mujer al estudio, cuando el varón sea la única pareja de la paciente. La información sobre la esterilidad masculina puede proceder del personal del centro: revisión de las historias clínicas del paciente, exploración física del paciente o espermiograma o entrevista con el paciente sobre su historia clínica.
    - Preservativo masculino combinado con espermicida vaginal (espuma, gel, película, crema o supositorio).
    - Preservativo masculino combinado con diafragma femenino, con o sin espermicida vaginal (espuma, gel, película, crema o supositorio).
    Estos métodos anticonceptivos permitidos sólo son eficaces cuando se utilizan de manera sistemática, correcta y de conformidad con la ficha técnica del producto. El investigador es responsable de garantizar que las pacientes conozcan el modo de empleo correcto de estos métodos anticonceptivos. Esta lista no se aplica a las MEF con parejas del mismo sexo, cuando éste sea su hábito preferido y habitual.
    Las mujeres no podrán ser incluidas en caso de estar embarazadas o en período de lactancia o de que tengan previsto quedarse embarazadas durante el período de participación en el estudio. En las MEF se realizará una prueba de embarazo en orina a intervalos periódicos durante todo el estudio y en la visita de retirada prematura o en las visitas de seguimiento si procede.
    4. Los medicamentos que se estén recibiendo para la enfermedad de Crohn deberán permanecer estables durante todo el período de estudio con la excepción de la reducción gradual de los corticoides y la reducción de la dosis de inmunodepresores para controlar la toxicidad. En el manual de procedimientos del estudio se ofrecen más detalles sobre los medicamentos permitidos.
    5. Los pacientes que estén recibiendo corticoides al incorporarse al estudio deberán estar dispuestos a someterse a una reducción gradual de los corticoides.
    E.4Principal exclusion criteria
    1. If female, is pregnant, has a positive pregnancy test or is breast-feeding
    2. Subjects with known or suspected coeliac disease or a positive screening test (antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive result
    3 Fixed symptomatic stenoses of small bowel or colon.
    4. Enterocutaneous , abdominal or pelvic fistulae likely to require surgery during the study period
    5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
    6. Use of prohibited medications at baseline and throughout the study (Section 5.5.3 of the protocol).
    7. The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT) and/or AST (SGOT) values ?2 times the upper limit of normal; has a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); has alkaline phosphatase >1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH); has known hepatic or biliary abnormalities with the exception of Gilbert?s syndrome or asymptomatic gallstones
    Note: At randomisation into the study, liver function tests results from the final visit in the preceding induction study will not be available . Subjects who have abnormalities as per the exclusion above will need to be withdrawn.
    1. Si el paciente es una mujer, está embarazada, da positivo en una prueba de embarazo o está en período de lactancia.
    2. Los pacientes con enfermedad celíaca conocida o sospechada o con una prueba de cribado positiva (anticuerpos antitransglutaminasa tisular (anti-TGt)) tendrán que haber sido excluidos de participar en los estudios de inducción. En los pacientes en que se sospeche posteriormente un diagnóstico de enfermedad celíaca se analizará la presencia de anticuerpos anti-TGt y se les excluirá o retirará del estudio en caso de un resultado positivo.
    3. Estenosis sintomáticas fijas del intestino delgado o el colon.
    4. Fístulas enterocutáneas, abdominales o pélvicas con probabilidad de precisar una intervención quirúrgica durante el período del estudio.
    5. Sepsis o infecciones presentes con necesidad de tratamiento antibiótico por vía intravenosa durante >2 semanas.
    6. Uso de medicamentos prohibidos en el momento basal y durante todo el estudio (Sección 5.5.3).
    7. El paciente presenta datos de disfunción hepática, hepatitis viral o valores de ALT sérica (SGPT) o AST (SGOT) >=2 veces el límite superior de la normalidad, un valor de bilirrubina total >1,5 veces el límite superior de la normalidad (una bilirrubina aislada >1,5 veces el límite superior de la normalidad es aceptable si la bilirrubina es fraccionada y la bilirrubina directa es <35 %), un valor de fosfatasa alcalina >1,5 veces el límite superior de la normalidad, antecedentes de hepatopatía presente o crónica, incluida esteatohepatitis no alcohólica (EHNA), o anomalías hepáticas o biliares conocidas, a excepción de síndrome de Gilbert o colelitiasis asintomática.
    Nota: en el momento de aleatorización en el estudio no se dispondrá de los resultados de las pruebas de función hepática de la visita final del estudio de inducción precedente. Los pacientes que presenten anomalías según los criterios de exclusión anteriores deberán retirarse del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy endpoints:

    Proportion of subjects in clinical remission (CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period

    Safety Endpoints:
    - Incidence of adverse events/serious adverse events
    - Change from baseline in vital signs: heart rate and blood pressure
    - Change from baseline in haematology and clinical chemistry parameters
    - Change from baseline in liver function test parameters
    - Change from baseline in 12 lead ECG abnormalities
    Valoración principal de eficacia:
    Proporción de pacientes en remisión clínica (puntuación CDAI <150 puntos) en las semanas 28 y 52 del período de tratamiento de 52 semanas.

    Valoración principal de seguridad:
    - Incidencia de acontecimientos adversos/ acontecimientos adversos graves.
    - Variación con respecto al momento basal de las constantes vitales: frecuencia cardíaca y presión arterial.
    - Variación con respecto al momento basal de los parámetros de hematología y bioquímica clínica.
    - Variación con respecto al momento basal de los parámetros de las pruebas de función hepática.
    - Variación con respecto al momento basal de las anomalías en el ECG de 12 derivaciones.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52
    and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.
    12 lead ECG at Week 0, 28, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.
    CDAI assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.
    Valoración de seguridad en la semana 0, 4, 8, 12, 20, 28, 36, 44, 52 y seguimiento después de 4 semanas en la semana 56, si el sujeto no es reclutado en el estudio de seguimiento.
    Se obtendrá un ECG de 12 derivaciones en las semanas 0, 28 y 52 y 4 semanas después del tratamiento, si el paciente no se incorpora al estudio de extensión abierto.
    Valoración del Índice de actividad de la enfermedad de Crohn en la Semana 0, 4, 8, 12, 20, 28, 36, 44, 52 y la semana de seguimiento después de 4 semanas en la Semana 56, si el sujeto no se recluta en el estudio de seguimiento.
    E.5.2Secondary end point(s)
    Key Secondary efficacy endpoint:
    Proportion of subjects in clinical remission (CDAI score <150 points) and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period
    Criterio de valoración secundario de la eficacia más importante
    Proporción de pacientes en remisión clínica (puntuación CDAI <150 puntos) y que no estén tomando corticoides en las semanas 28 y 52 del período de tratamiento de 52 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 28 and 52
    Semanas 28 y 52
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA158
    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 Information not present in EudraCT
    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
    Australia
    Austria
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Switzerland
    Taiwan
    United Kingdom
    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
    Last Subject Last Visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    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: 718
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 750
    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)
    The investigator is responsible for maintaining the post study care of a patient's medical condition. Subjects, on completion of the study after 52 weeks, may be eligible for an open-label study with GSK1605786A (study CCX114644). Subjects who do not enter study CCX114644 will not receive further treatment provided by GSK but will return for a Follow-up visit at Week 56. Subsequent treatment for Crohn's disease will be at the discretion of the investigator.
    El investigador es responsable de mantener el cuidado después del estudio de la enfermedad del paciente. Los sujetos, al completar el estudio después de 52 semanas, puede ser elegible para un estudio abierto con GSK1605786A (estudio CCX114644). Los sujetos que no entren en el estudio CCX114644 no recibirán más tratamiento proporcionado por GSK, pero volverán para una visita de seguimiento en la Semana 56. El tratamiento posterior para la enfermedad de Crohn será a discreción del investigador.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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