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    The EU Clinical Trials Register currently displays   34922   clinical trials with a EudraCT protocol, of which   5688   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004784-58
    Sponsor's Protocol Code Number:GA08/8725
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-04-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-004784-58
    A.3Full title of the trial
    An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial.
    A.3.2Name or abbreviated title of the trial where available
    Effect of Infliximab on MRI lesions in Crohn's - ACTIF study
    A.4.1Sponsor's protocol code numberGA08/8725
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Leuven Hospitals
    B.1.3.4Country
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor B.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameRemicade
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfliximab
    D.3.9.1CAS number 170277313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The prinicipal aim of this study is to investigate the effect of infliximab on the transmural Inflammatory component and the fibrous lesions in the distal small bowel in patients with Crohn’s disease, based on serial MRI. This is a diagnostic, observational trial.

    The primary endpoint of this study is the number of patients achieving a clinically significant change in MRI enteroclysis inflammatory sub-scores of severity in Ileal Crohn’s Disease (MICD); this is defined as an improvement of at least 2 points and at least 50% on the inflammatory subscores. i.e. 4 to 2 or 5 to 2 or 8 to 4 (subscores defined in section 19), as measured with contrast enhanced MRI enteroclysis at week 26 compared to baseline
    E.2.2Secondary objectives of the trial
    Secondary endpoints include:
    1) Changes in the overall MICD score at week 2 and week 26 compared to baseline
    2) Changes in the individual MICD inflammatory subscores (wall thickening, contrast enhancement and extramural involvement) at week 2 and week 26 compared to baseline.
    3) Changes in the individual MICD criteria for obstructive disease (intrastenotic luminal diameter and prestenotic dilation) at week 2 and week 26 compared to baseline.
    4) Number of patients reaching CDAI remission (< 150) or CDAI response criteria (a drop of 100 points) at every visit (except week 30).
    5) Correlation between the MICD total score and CDAI at baseline, week 2 and 26
    6) Correlation between different MICD inflammatory subscores and CDAI at baseline, week 2 and 26
    7) Correlation between the different MICD criteria for obstructive disease and CDAI at baseline, week 2 and 26
    8) Changes in disease activity as measured with CDAI and Harvey Bradshaw questionnaire at every visit (except week 30).
    9
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    To be eligible for the trial, patients must meet all of the following inclusion criteria:
    1) Men and women ≥ 18 and ≤ 65 years of age,
    2) Are capable of understanding and signing an informed consent
    3) Are considered eligible according to the following tuberculosis (TB) screening criteria:
    a) Have no history of latent or active TB prior to screening
    b) Have no signs or symptoms suggestive of active TB upon medical history or physical examination
    c) Have had no recent close contact with a person with active TB
    d) Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of infliximab and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
    4) The presence of active disease:
    a) CDAI > 220
    b) CRP > 5 mg/L (see amendment to protocol)
    5) Strong Gadolinium (Gd) uptake on baseline contrast enhanced MRI enteroclysis (see MRI manual)
    6) Ileal wall thickening of > 4 mm on baseline contrast enhanced MRI enteroclysis
    7) Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last medication

    Exclusion Criteria:
    Patients who meet any of the following criteria may not be enrolled in the study:
    1) Have a medical contraindication for MRI enteroclysis (eg metal implants, including metal prosthetic heart valve(s), implantable devices, including a cardiac pacemaker and severe claustrophobia)
    2) use more than 15 mg of oral steroids (prednisone or equivalent) within the 2 weeks prior to baseline MRI. IV use of steroids is not allowed within that same period
    3) Have a severe prestenotic dilation of the ileum on screening MRI (severe dilation is defined as > 2 times the luminal diameter of the unaffected ileum)
    4) Have had bowel resection of > 100 cm
    5) Have presence of an abdominal abscess
    6) Have MRI enteroclysis confirmed internal fistula
    7) Be considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules (refer to sections 5.9 and 18).
    8) Have Screening laboratory test results as follows:
    a) White blood cells (WBCs) < 3.0 x 109 cells/L
    b) Platelets < 100 X 109 cells/L
    c) Serum creatinine > 132 ╬╝mol/L (> 1,5 mg/dL)
    d) Serum transaminase levels exceeding 2 times the upper limit of normal for the site laboratory
    9) Have had any previous treatment with monoclonal antibodies or antibody fragments
    10) Have a history of receiving human/murine recombinant products or a known allergy to murine products
    11) Have documentation of seropositivity for human immunodeficiency virus (HIV)
    12) Have a positive test for hepatitis B surface antigen or hepatitis C
    13) History of alcohol or substance abuse in the 6 months prior to the study
    14) Have a known history of serious infections (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
    15) Have a known history of a demyelinating disease, such as multiple sclerosis
    16) Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
    17) Have a chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg. bronchiectasis), sinusitis, recurrent urinary tract infection, open, draining or infected skin wound or ulcer
    18) Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly
    19) Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence
    20) Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
    21) Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access
    22) Use any investigational drug within 3 months prior to screening or within 5 half-lives of the investigational agent, whichever is longer
    23) Have presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening)
    24) Have a concomitant diagnosis or history of congestive heart failur
    E.4Principal exclusion criteria
    Ssee E3
    Significant prestenotic dilatation of the ileum on baseline MRI scan
    Previous resection of more than 100cm bowel
    Presence of abdominal abscess
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number of patients achieving a clinically significant change in MRI enteroclysis score of severity in Ileal Crohn’s Disease (MICD); defined as an improvement of at least 2 points and at least 50% on the inflammatory subscores. i.e. 4 to 2 or 5 to 2 or 8 to 4, as measured with contrast enhanced MRI enteroclysis at week 26 compared to baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Information not present in EudraCT
    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
    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 days
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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)
    This treatment is standard of care in Leeds Teaching Hospitals NHS Trust and treatment will continue according to local policies after study completion.
    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 Decision2009-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-11-26
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