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    Summary
    EudraCT Number:2004-002815-10
    Sponsor's Protocol Code Number:C0168T67
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-05-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-002815-10
    A.3Full title of the trial
    Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC
    A.3.2Name or abbreviated title of the trial where available
    SONIC
    A.4.1Sponsor's protocol code numberC0168T67
    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 B.V.
    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 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 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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Imuran
    D.2.1.1.2Name of the Marketing Authorisation holderPrometheus Laboratories Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameImuran
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNazathioprine
    D.3.9.3Other descriptive name6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate to severe Crohn’s Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Classification code 10011401
    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 of the Main Study will be to compare the efficacy of infliximab + placebo capsules and infliximab combined with azathioprine (AZA) to azathioprine + placebo infusions in the treatment of patients with moderate-to-severe Crohn’s disease.

    The primary objective of the Study Extension will be to evaluate the long-term efficacy and safety of infliximab and/or AZA through week 54.
    E.2.2Secondary objectives of the trial
    1) To assess the effect of infliximab and/or AZA on complete mucosal healing in patients with Crohn’s disease.

    2) To assess the corticosteroid-sparing abilities of therapy with infliximab and/or AZA in patients with moderate-to-severe Crohn’s disease.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be eligible for the trial, patients must meet all of the following criteria:

    1) 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 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.

    2) Are 18 years of age or older at the time of informed consent; may be male or female.

    3) Have a CDAI score of ≥ 220 and ≤ 400.

    4) Have Crohn’s disease of at least 6 weeks duration, with colitis, ileitis, or ileocolitis, confirmed by radiography or endoscopy.

    5) Are EITHER:
    a. Corticosteroid-dependent (ie, patients who become symptomatic after a decrease in corticosteroid dose such that they have a CDAI ≥ 220 [budesonide alone does not qualify as a corticosteroid for the purpose of this criterion]), OR
    b. Are being considered for their second (or greater) course of oral systemic corticosteroids (prednisone or equivalent), (budesonide alone does not qualify as a corticosteroid for the purpose of this criterion) for active Crohn’s disease within the past 12 months, OR
    c. Are 5-ASA failures (i.e., patients who have not had an adequate response to a course of 5-ASA [sulfasalazine] 3 g/day for at least 4 weeks, or mesalamine 2.4 g/day or equivalent for at least 4 weeks). OR
    d. Are budesonide failures (i.e., patients who have not had an adequate response to a course of budesonide 6 mg/day for at least 4 weeks). Budesonide failures who are 5-ASA-naive are eligible for this study.

    6) Are able to adhere to the concomitant medication requirements as described in the protocol, section 4.1: Inclusion Criteria (under bullet six).

    7) Are able to adhere to the study visit schedule and other protocol requirements.

    8) Are capable of providing written informed consent. Written informed consent must be obtained prior to performing any study-related procedures.

    9) Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the study and must continue such precautions for 6 months after receiving the last study agent infusion.

    10) The screening laboratory tests must meet the following criteria:
    a. Hemoglobin > 8.5 g/dL
    b. White blood cell (WBC) count > 3.5 billion cells/L
    c. Neutrophils > 1.5 billion cells/L
    d. Platelets >100 billion cells/L
    e. Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) levels must be within 2 times the upper limit of normal (ULN) for the laboratory conducting the test. Alkaline phosphatase levels must be within 3 times ULN for the laboratory conducting the test.
    E.4Principal exclusion criteria
    Patients who:
    1) Have local manifestations of Crohn’s disease such as strictures, abscesses, or other disease complications for which surgery might be indicated (conditions possibly confounding the evaluation of benefit from study treatment) or which might preclude utilization of CDAI to assess response to therapy If an abscess has been present previously, at least 6 weeks must have elapsed between drainage of the abscess and screening. 2) Have had intra-abdominal surgery within 3 months prior to screening. 3) Have received treatment with pure parenteral nutrition (TPN) within 6 weeks of screening. Enteral nutrition therapy is permitted. 4) Have an ostomy or stoma. 5) Have known severe fixed symptomatic stenosis of the large or small intestine. 6) Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter. 7) Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody). 8) Have a known allergy to murine proteins or other chimeric proteins. 9) Have received within 3 months prior to screening or are expected to receive any live virus (eg, small pox) or live bacterial vaccinations during the trial or up to 3 months after the last administration of study agent. 10) Have had a serious infection (eg, hepatitis, pneumonia, or pyelonephritis), or have been hospitalized for an infection, or have been treated with intravenous antibiotics for an infection within 2 months prior to screening. 11) Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening. 12) Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening. 13) Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to screening. 14) Have a chest radiograph within 3 months prior to randomization that shows an abnormality suggestive of a malignancy or current active infection, including TB. 15) Are considered ineligible according to the TB eligibility assessment, screening and early detection of reactivation rules defined in the protocol. 16) Have documented current active hepatitis B (surface antigen positive) or a history of documented hepatitis C infection. 17) Have documented human immunodeficiency virus (HIV) infection. 18) Have current signs or symptoms of or a history of systemic lupus erythematosus; severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases.
    19) Have a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to screening). 20) Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location or splenomegaly. 21) Have any known malignancy or history of malignancy within the 5-year period prior to screening (except for squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence). 22) Have multiple sclerosis or other central demyelinating disorder. 23) Have had a chronic or recurrent infectious disease including but not limited to chronic renal infection; chronic chest infection (eg, bronchiectasis); sinusitis; recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis); open, draining, or infected skin wound or ulcer. 24) Have a serious concomitant illness that could interfere with the patient’s participation in the trial. 25) Have used any investigational drug within 30 days prior to screening, or within 5 half-lives of the investigational agent, whichever is longer. 26) Are currently participating in another investigative trial using an investigational agent, procedure, or medical device during participation in this trial. 27) Have previously participated in 3 or more investigative trials in Crohn’s disease within 5 years prior to screening. Participation in registry studies (eg, TREAT) does not constitute an Exclusion criterion. Patients participating in the TREAT registry must discontinue from the registry before enrolling in SONIC. 28) Have a history of substance abuse (drug or alcohol) within the previous 3 years, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the patient’s adherence to protocol requirements (eg, psychiatric disease, lack of motivation, travel, etc). 29) Have a concomitant diagnosis or any history of congestive heart failure (CHF). 30) Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access. 31) Are known to have a homozygous mutant or heterozygous thiopurine methyltransferase (TPMT) phenotype. 32) Weigh more than 140 kg (310 lbs).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the proportion of patients in corticosteroid-free clinical remission, ie, patients with a CDAI of less than 150 who have not been taking oral systemic corticosteroids (prednisone or equivalent) for at least 3 weeks and have not been taking budesonide at a dose greater than 6 mg/day for at least 3 weeks at week 26.
    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 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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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 Yes
    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) Yes
    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.8.5The trial involves multiple Member States Yes
    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 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
    N.A.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-16. Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 234
    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)
    N.A.
    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 Decision2005-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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