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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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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    Summary
    EudraCT Number:2008-000649-77
    Sponsor's Protocol Code Number:C0743T26
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-03
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-000649-77
    A.3Full title of the trial
    A Phase 2b, Multicenter, Randomized, Double-blind,
    Placebo-controlled, Parallel-group Study to Evaluate the Efficacy
    and Safety of Ustekinumab Therapy in Subjects with Moderately
    to Severely Active Crohn’s Disease Previously Treated with TNF
    Antagonist Therapy
    A.3.2Name or abbreviated title of the trial where available
    CERTIFI
    A.4.1Sponsor's protocol code numberC0743T26
    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 SponsorCentocor BV
    B.1.3.4CountryNetherlands
    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 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 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 nameUstekinumab
    D.3.2Product code CNTO 1275
    D.3.4Pharmaceutical form Concentrate 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 INNUstekinumab
    D.3.9.2Current sponsor codeCNTO 1275
    D.3.9.3Other descriptive nameHuman Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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.IMP: 2
    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 nameUstekinumab
    D.3.2Product code CNTO 1275
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNUstekinumab
    D.3.9.2Current sponsor codeCNTO 1275
    D.3.9.3Other descriptive nameHuman Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 typeMonocloncal Antibody
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Crohn’s Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To evaluate the efficacy of ustekinumab in inducing clinical response.
    To evaluate the safety of ustekinumab.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ustekinumab in inducing clinical remission, fistula response, and mucosal healing. To obtain data to support selection of a maintenance dose regimen for continued clinical development. To explore the pharmacokinetics and pharmacodynamics of ustekinumab therapy. To evaluate the efficacy of ustekinumab in achieving delayed clinical response.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic analyses of blood samples and mucosal biopsy samples. For further details reference is made to the main study protocol (section 8.2)
    E.3Principal inclusion criteria
    - Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration,
    with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
    - Have active disease, defined as a baseline CDAI score of ≥ 220 and ≤ 450.
    - Have received infliximab, adalimumab, or certolizumab pegol at a dose approved
    for the treatment of Crohn’s disease and:
    a. Did not respond initially (ie, primary nonresponders). or
    b. Responded initially but then lost response with continued therapy
    (ie, secondary nonresponders). or
    c. Were intolerant to the medication.
    - Are men or women who are ≥ 18 years of age at time of consent.
    - Adhere to the following concomitant medication requirements relative to the first
    study agent administration at baseline (Week 0).
    a. 5-ASA compounds.
    b. Oral corticosteroids (eg, prednisone, budesonide)
    c. Crohn’s disease-specific antibiotics
    d. Immunomodulators:
    -Women of childbearing potential and all men must be using adequate birth control
    measures
    - Have the capacity to understand and sign an informed consent form.
    - Be able to adhere to the study visit schedule and other protocol requirements.
    - Have screening laboratory test results within the following parameters:
    - Hemoglobin > 8.5 g/dL
    - WBCs ≥ 3.5 x 103/µL
    - Neutrophils ≥ 1.5 x 103/µL
    - Platelets ≥ 100 x 103/µL
    - Serum creatinine < 1.5 mg/dL
    - AST and ALT concentrations must be within 2 times the ULN range for the
    laboratory conducting the test.
    - Direct (conjugated) bilirubin < 2.0 mg/dL.
    - Are considered eligible according to the following 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
    and/or physical examination.
    c. Have had no recent close contact with a person with active TB or, if there has
    been such contact, will be referred to a physician specializing in TB to
    undergo additional evaluation and, if warranted, receive appropriate
    treatment for latent TB prior to or simultaneously with the first administration
    of study agent.
    d. Within 2 months prior to the first administration of study agent, either have
    negative diagnostic TB test results (defined as a negative QuantiFERON-TB
    Gold In-Tube test), or have a newly identified positive diagnostic TB test
    result (defined as a positive QuantiFERON-TB Gold In-Tube test) during
    screening in which active TB has been ruled out and for which appropriate
    treatment for latent TB has been initiated either prior to or simultaneously
    with the first administration of study agent.
    e. Have a chest radiograph (both posterior-anterior and lateral views), taken
    within 3 months prior to the first administration of study agent and read by a
    qualified radiologist, with no evidence of current active TB or old inactive
    TB.
    E.4Principal exclusion criteria
    - Have complications of Crohn’s disease such as strictures, stenoses, short gut
    syndrome, or any other manifestation that might require surgery, could preclude the
    use of the CDAI to assess response to therapy, or would possibly confound the
    evaluation of benefit from treatment with ustekinumab.
    - Have any current or prior abscesses, unless they have been drained and treated at
    least 6 weeks prior to baseline and are not anticipated to require surgery. Subjects
    with active fistulas may be included if there is no anticipation of a need for surgery
    and there are currently no abscesses present.
    - Have had any kind of bowel resection, diversion, or placement of a stoma within
    months or any other intra-abdominal surgery within 3 months prior to screening.
    - Have received treatment with total parenteral nutrition (TPN) within 2 weeks of
    screening.
    - Have a stool culture or other examination positive for an enteric pathogen,
    including Clostridium difficile toxin, in the last 4 months unless a repeat
    examination is negative and there are no signs of ongoing infection with that
    pathogen.
    - Are pregnant, nursing, or planning pregnancy (both men and women) while
    enrolled in the study, or within 20 weeks after receiving the last dose of study agent.
    - Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but
    not limited to, ustekinumab (CNTO 1275) and ABT-874.
    - Have used any investigational drug within the previous 4 weeks or 5 times the
    half-life of the investigational agent prior to the first administration of study agent,
    whichever is longer.
    - Have used any TNF antagonist ≤ 8 weeks prior to the first administration of study
    agent or any other biologic ≤ 12 weeks prior to the first administration of study
    agent or within 5 times the half-life of the biologic prior to the first administration
    of study agent, whichever is longer.
    - Have received natalizumab, efalizumab, or agents that deplete B or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
    - Have used apheresis (eg, Ada column apheresis) ≤ 2 weeks prior to screening.
    - Have received any live bacterial or viral vaccination ≤ 12 weeks prior to Week 0.
    Subjects must agree not to receive a live virus or bacterial vaccination during the
    study or up to 12 months after the last administration of study agent.
    - Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of
    screening. Subject must agree not to receive a BCG vaccination during the study or
    up to 12 months after the last study agent administration.
    - Have a history of, or ongoing, chronic or recurrent infectious disease.
    - Have current signs or symptoms of infection or history of serious infection.
    - Have evidence of a herpes zoster infection ≤ 8 weeks of screening.
    - Have a history of latent or active granulomatous infection.
    - Have evidence of current active infection.
    - Have or ever have had a nontuberculous mycobacterial infection or serious
    opportunistic infection.
    - Are known to be infected with human immunodeficiency virus, hepatitis B, or
    hepatitis C.
    - Have severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine,
    pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and
    symptoms thereof.
    - Have a transplanted organ (with exception of a corneal transplant > 12 weeks prior
    to screening) or have ever received stem cell therapy (eg, Prochymal).
    - Have a known history of lymphoproliferative disease, including lymphoma, or
    signs and symptoms suggestive of possible lymphoproliferative disease, such as
    lymphadenopathy and/or splenomegaly.
    - Have any known malignancy or have a history of malignancy.
    - Are known to have had a substance abuse (drug or alcohol) problem within the
    previous 12 months.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response at Week 6
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    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 years2
    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 years2
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 500
    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)
    Not Applicable
    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 Decision2008-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-09
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