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    The EU Clinical Trials Register currently displays   43691   clinical trials with a EudraCT protocol, of which   7245   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).

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    EudraCT Number:2011-004268-31
    Sponsor's Protocol Code Number:20110118
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2011-004268-31
    A.3Full title of the trial
    Adalimumab (Humira) in the treatment of chronic pouchitis
    Adalimumab (Humira) til behandling af kronisk pouchitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adalimumab (Humira) in the treatment of chronic pouchitis
    Adalimumab (Humira) til behandling af kronisk pouchitis
    A.4.1Sponsor's protocol code number20110118
    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 SponsorOdense University Hospital
    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 supportOdense University Hospital
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital
    B.5.2Functional name of contact pointMie Dilling Kjaer
    B.5.3 Address:
    B.5.3.1Street AddressSdr Boulevard 29
    B.5.3.2Town/ cityOdense c
    B.5.3.3Post code5000
    B.5.4Telephone number004565414848
    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. name Humira 40 mg solution for injection in pre-filled syringes
    D. of the Marketing Authorisation holderAbbott Labotories Limited
    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 nameHumira
    D.3.2Product code EMEA/H/C/000481
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis
    Kronisk pouchitis efter proktokolektomi og rekonstruktion med en J-pouch og med colitis ulcerosa som primære diagnose
    E.1.1.1Medical condition in easily understood language
    Chronic inflammation in a reservoir of small intestine after removal of the colon and with ulcerative colitis as primary diagnosis
    Kronisk betændelsestilstand i et tyndtarmsreservoir (pouch) efter fjernelse af tyktarmen med colitis ulcerosa som primære diagnose
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10036463
    E.1.2Term Pouchitis
    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
    The primary objective is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis.
    Det primære formål er at evaluere den kliniske effekt af biologisk behandling (adalimumab) hos patienter med kronisk pouchitis.
    E.2.2Secondary objectives of the trial
    Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity.
    De sekundære formål er at evaluere effekten af biologisk behandling på den endoskopiske og den histologiske inflammatoriske aktivitet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Operated with proctocolectomy and construction of an IPAA
    • Prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria.
    • Diagnosed with chronic pouchitis as defined above
    • PDAI ≥ 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3
    • Age >18 years
    • Negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites
    • Serology negative for chronic hepatitis B
    • Negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test)
    • Signed informed consent
    • Opereret med proktokolektomi og konstruktion af en IPAA
    • Forud for kirurgi diagnosticeret med colitis ulcerosa ifølge etablerede kliniske, radiologiske, endoskopiske og histologiske kriterier.
    • Diagnosticeret med kronisk pouchitis, som defineret ovenfor
    • PDAI> 7, med den kliniske del af PDAI> 2 og den endoskopiske del af PDAI> 3
    • Alder> 18 år
    • Anvendelse af sikker antikonception hos fertile kvinder og negativ urin HCG ved inklusion
    • Negativ fæces dyrkning for tarmpatogene bakterier og negative fæces mikroskopi for parasitter
    • Negativ serologi for kronisk hepatitis B og HIV
    • Negativ undersøgelse for tuberkulose (herunder rgt.af thorax og en interferon gamma-test)
    • Underskrevet informeret samtykke
    E.4Principal exclusion criteria
    • Treatment with glucocorticoids within the last 4 weeks
    • Diagnosed with Crohn’s disease
    • Need of an interpreter or if patients do not understand oral or written information.
    • Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch
    • Abuse of medicine, alcohol or drugs
    • Ongoing treatment with NSAID (non steroid anti inflammatory drug)
    • Pregnancy or nursing
    • A diverting stoma
    • Malignancy or other severe chronic disease or expected longevity less than one year
    • Patients diagnosed with immune deficiency
    • Ongoing infectious disease
    • Contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks
    • Behandling med glukokortikoider inden for de sidste 4 uger
    • Diagnosticeret med Crohns sygdom
    • Behov for en tolk, eller hvis patienten ikke forstår mundtlig eller skriftlig information.
    • Kirurgiske komplikationer som anal stenose, anastomoselækage eller fistler udgående fra pouchen
    • Medicin-, alkohol- eller narkotikamisbrug
    • Igangværende behandling med NSAID (non steroide anti inflammatoric drug)
    • Graviditet og amning
    • En aflastende stomi
    • Malignitet eller andre alvorlige kroniske sygdomme eller forventet levetid mindre end et år
    • Patienter diagnosticeret med immundefekt
    • Pågående infektiøs sygdom
    • Kontraindikationer mod behandling med tumornekrosefaktor-alfa-antistof, såsom hjertesygdomme, tidligere kræftsygdom, in vivo vaccination inden for de sidste 4 uger
    E.5 End points
    E.5.1Primary end point(s)
    The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically Pouchitis Disease Activity Index (PDAI) ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira).
    Antallet af patienter med kronisk pouchitis, der opnår en klinisk forbedring defineret som en reduktion i klinisk Pouchitis Disease Activity Index (PDAI) ≥ 2 når som helst inden for 12 ugers behandling med adalimumab (Humira).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 uger
    E.5.2Secondary end point(s)
    (1) The number of patients with a clinical improvement at week 12
    (2) The number of patients with pouchitis in remission at week 12 (total PDAI <=4)
    (3) Effect of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis.
    (1) Antallet af patienter med en klinisk forbedring ved uge 12
    (2) Antallet af patienter med remission i uge 12 (total PDAI ≤ 4)
    (3) Effekt af adalimumab (Humira) på endoskopisk og histologisk aktivitet ved kronisk pouchitis
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 uger
    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 No
    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. 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 concerned3
    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 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
    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 months
    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: 24
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Conventional therapy undtil study results are available
    Konventionel behandling indtil forsøgsresultater foreligger
    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 Decision2011-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-30
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