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    Summary
    EudraCT Number:2005-000181-39
    Sponsor's Protocol Code Number:C0168X84, EU-0108
    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:2005-07-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2005-000181-39
    A.3Full title of the trial
    A Prospective Trial of Anti-TNF-a Chimeric Monoclonal Antibody (infliximab, Remicade®) on Insulin Sensitivity, Beta Cell Function and Cardiovascular Risk Profile in Insulin Resistant Human Obesity
    A.4.1Sponsor's protocol code numberC0168X84, EU-0108
    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 SponsorMed. Universitaetsklinik Graz, ao Univ. Professor Dr. med. Thomas C. Wascher
    B.1.3.4CountryAustria
    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 Information not present in EudraCT
    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 AuthorisationAustria
    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.3.2Product code cA2
    D.3.4Pharmaceutical form Powder for solution for injection
    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.3.9.3Other descriptive nameAnti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    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
    Insulin Resistant Human Obesity
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the study are to test whether neutralizing TNF-α with infliximab affects insulin resistance and phenotypical manifestations of the metabolic syndrome such as:
    - Fasting plasma insulin
    - Iv-GTT derived parameters of insulin resistance and β-cell function
    - Total body fat
    - Plasma lipid profile
    - Vascular endothelial dysfunction
    - Circulating markers of inflammation and endothelial dysfunction
    E.2.2Secondary objectives of the trial
    not defined
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects to be included must meet the following criteria:

    1. Men between 20 and 50 years of age.
    2. BMI between and including 30 and 35 kg/m2
    3. HOMA index > 2.5
    4. History of stable weight (+/- 2 kg) > 3 months
    5. Blood pressure > 135 / 85 mmHg (or treated hypertension)
    6. Triglycerides > 1.7 mmol/l or HDL-cholesterol < 1.3 mmol/l
    7. Men or their partner must use adequate birth control measures (eg, abstinence,
    oral contraceptives, intrauterine device, barrier method with spermicide, or
    surgical sterilization) for the duration of the study and should continue such
    precautions for 6 months after receiving the last infusion.
    8. The screening laboratory test results must meet the following criteria:
    a. Hemoglobin >= 8.5 g/dL
    b. WBC >= 3.5 x 10 hoch 9/L
    c. Neutrophils >= 1.5 x 10 hoch 9/L
    d. Platelets >= 100 x 10 hoch 9/L
    e. SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper
    limit of normal range for the laboratory conducting the test.

    9. Subject must be able to adhere to the study visit schedule and other protocol
    requirements.
    10. The subject must be capable of giving informed consent and the consent must
    be obtained prior to any screening procedures.
    11. Must have a chest radiograph within 3 months prior to first infusion with no
    evidence of malignancy, infection or fibrosis.
    12. 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
    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 1 month prior to the first administration of study agent, either have a
    negative tuberculin skin test, as outlined in Appendix B, or have a newly
    identified positive tuberculin skin 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
    Subjects will be excluded from this study for any of the following reasons:

    1. Patients with overt diabetes (fasting glucose > 7.0 mmol/l).
    2. Current treatment with angiotensin II antagonists or ACE inhibitors.
    3. Treatment indication with statins according to the current NCEP III criteria.
    4. Treatment indication with low dose acetylsalicylic acid according to the current
    AHA quidelines or any other NSAID.
    5. Current smokers.
    6. Patients with (a history of) an autoimmune disease.
    7. Use of any investigational drug within 1 month prior to screening or within 5 half-
    lives of the investigational agent, whichever is longer.
    8. Treatment with any other therapeutic agent targeted at reducing TNFα (eg,
    pentoxifylline, thalidomide, etanercept, adalimumab) within 3 months of screening.
    9. Previous administration of infliximab.
    10. History of receiving human/murine recombinant products or known allergy to
    murine products.
    11. Serious infections (such as pneumonia or pyelonephritis) in the previous 3
    months. Less serious infections (such as acute upper respiratory tract infection
    [colds] or simple urinary tract infection) need not be considered exclusions at the
    discretion of the investigator.
    12. Documented HIV infection.
    13. Active hepatitis- B or antibodies against hepatitis-C
    14. Have a history of latent or active granulomatous infection, including TB,
    histoplasmosis, or coccidioidomycosis, prior to screening.
    15. Have or have had a opportunistic infection (eg, herpes zoster [shingles],
    cytomegalovirus, Pneumocystis carinii, aspergillosis,) within 6 months prior to
    screening.
    16. Have current signs or symptoms of severe, progressive or uncontrolled renal,
    hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,
    or cerebral disease (including demyelinating diseases such as multiple sclerosis).
    17. Concomitant congestive heart failure, including medically controlled
    asymptomatic patients.
    18. Presence of a transplanted organ (with the exception of a corneal transplant > 3
    months prior to screening).
    19. Malignancy within the past 5 years (except for squamous or basal cell carcinoma
    of the skin that has been treated with no evidence of recurrence).
    20. History of lymphoproliferative disease including lymphoma, or sign and symptoms
    suggestive of possible lymphoproliferative disease, such as lymphadenopathy of
    unusual size or location (such as nodes in the posterior triangle of the neck,
    infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
    21. Known recent substance abuse (drug or alcohol).
    22. Poor tolerability of venipuncture or lack of adequate venous access for required
    blood sampling during the study period.
    23. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of
    screening.
    24. Have a chest radiograph within 3 months prior to randomization that shows an
    abnormality suggestive of a malignancy or current active infection, including TB.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the change in fasting insulin levels between base line levels (day 0) and day 70.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    End of trial is defined as a patient completing the last scheduled visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state18
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 18
    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)
    continuation of normal treatment
    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 Decision2005-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-19
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