Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-001723-12
    Sponsor's Protocol Code Number:CSAI
    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:2013-08-14
    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 number2012-001723-12
    A.3Full title of the trial
    A randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients
    Estudio aleatorizado, enmascarado, controlado con placebo sobre los efectos de adalimumab intralesional en estenosis intestinales de pacientes con enfermedad de Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    adalimumab intralesional in intestinal strictures of Crohn's disease patients
    adalimumab intralesional en estenosis intestinales de pacientes con enfermedad de Crohn
    A.4.1Sponsor's protocol code numberCSAI
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundació Clínic per a la Recerca Biomèdica
    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 supportdel Ministerio de Economía y Competitividad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit - Hospital Clinic of Barcelona
    B.5.2Functional name of contact pointCTU CLINIC
    B.5.3 Address:
    B.5.3.1Street Addressvillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322754003343
    B.5.5Fax number0034932279877
    B.5.6E-mailsvarea@clinic.ub.es
    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.3.1Product nameAdalimumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntralesional 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 number80
    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
    D.8.4Route of administration of the placeboIntralesional use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn disease
    enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn disease
    enfermedad de Crohn
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine that intralesional administration of Adalimumab associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo
    Determinar que la inyección intralesional de Adalimumab asociado a la dilatación endoscópica consigue una mayor proporción de éxito a la semana 8 comparado con dilatación + placebo
    E.2.2Secondary objectives of the trial
    -To demonstrate that the intralesional injection of Adalimumab associated with endoscopic dilatation will decrease the necessity of endoscopic redilatation or surgery at week 52
    -To evaluate the mucosal cure rate associated with the stenosis resolution at week 8 and week 52 after endoscopic dilatation, defined, in case of postsurgical stenosis, as Rutgeert´s index equal or less than 2
    -To evaluate the complication incidence associated with every one of realized procedures as well as the adverse events in every group of treatment
    -To analyze the rate of formation of anti-adalimumab antibodies during the follow up after unique local injection of the drug
    -To determinate the histological cure rate at week 8 after the injection of the drug or placebo
    -Demostrar que la inyección intralesional de Adalimumab asociada a la dilatación endoscópica consigue reducir la necesidad de redilatación endoscópica o cirugía a la semana 52
    -Valorar la tasa de curación mucosa asociada a la resolución de la estenosis a la semana 8 y la semana 52 después de la dilatación endoscópica, definida, en el caso de estenosis postquirúrgica, como un Índice de Rutgeerts menor o igual que 2
    -Evaluar la tasa de complicaciones asociadas a cada uno de los procedimientos realizados así como de acontecimientos adversos en cada uno de los grupos de tratamiento
    -Analizar la tasa de anticuerpos anti-adalimumab desarrollados en el seguimiento tras una única inyección local del fármaco
    -Determinar la tasa de curación histológica a las 8 semanas de la inyección del fármaco o placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients of both sexes older than 18 years
    -Patient diagnosed of CROHN´s disease
    -Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
    -Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
    -Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
    -Patient capable of participate in the examinations required by the study
    -Patient after being informed, give his/her informed consent in writing
    ?Pacientes de ambos sexos mayores de 18 años?Paciente diagnosticado de enfermedad de Crohn
    ?Paciente con estenosis intestinales de longitud igual o inferior a 5 cm confirmadas previamente por enterorresonancia (3 estenosis como máximo)
    ?Estenosis no permeables al endoscopio (12mm en caso de estenosis accesibles al colonoscopio convencional y 10 mm en caso de estenosis accesibles a enteroscopio de balón)
    ?Estenosis dilatadas según criterio del endoscopista (pase o no el endoscopio)
    ?Paciente capaz de someterse a las pruebas y exploraciones que requiere el estudio
    ?Paciente que, tras ser informado, otorga su Consentimiento Informado por escrito
    E.4Principal exclusion criteria
    -Patients with large intestinal stenosis (more than 6cm) and multiples
    -Patients with previous or actual treatment with anti-TNF drugs
    -Patients with positive serology to HBV,HCV, or HIV
    -Patients with positive screening to Tuberculosis(positive PPD)
    -Established contraindication to anti-TNF drugs
    -Existence of fistulous tracts associated with intestinal stenosis
    -Neoplastic process associated with stenosis or in another location
    -Pregnancy or breastfeeding
    ?Pacientes con estenosis intestinales largas (superiores a 6 cm) y múltiples (más de 3 estenosis)
    ?Pacientes en tratamiento previo o actual con un fármaco anti-TNF
    ?Pacientes con serologías positivas de Virus de Hepatitis B (VHB), Virus Hepatitis C (VHC) o VIH
    ?Pacientes con screening positivo a tuberculosis (PPD positivo a TBC)
    ?Contraindicación establecida para el uso de fármacos anti-TNF
    ?Existencia de trayectos fistulosos asociados a la estenosis intestinal
    ?Procesos neoplásicos asociados a la estenosis o en otra localización
    ?Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    -Success of endoscopic dilatation at week 8
    -éxito de la dilatación endoscópica a las 8 semanas
    E.5.1.1Timepoint(s) of evaluation of this end point
    8weeks
    8semanas
    E.5.2Secondary end point(s)
    -The estimation of stenosis measure , the endoscopic pre and post-dilatation stenosis diameter will be estimated
    -The success of endoscopic dilatation at week 52(absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation)
    -Mucosal cure at week 8
    -Histological cure at week 8
    -Proportion of patients the develop anti-adalimumab antibodies
    -Se realizará una estimación de la medida de la estenosis, se estimará el diámetro de la estenosis pre y post-dilatación endoscópica
    -Éxito de la dilatación endoscópica a las 52 semanas (ausencia de clínica suboclusiva, no necesidad de cirugía ni de redilatación endoscópica)
    -Curación de la mucosa a las 8 semanas
    -Curación histológica a las 8 semanas
    -Proporción de pacientes que desarrollan anticuerpos anti-adalimumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 and 52 weeks
    8 y 52 semanas
    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 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 Yes
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is last follow up visit of the last subject undergoing the trial
    La finalización del estudio del ensayo coincidirá con la fecha de la última visita de seguimiento del último sujeto incluido en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state102
    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 Decision2013-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-12
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 16:02:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA