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    Summary
    EudraCT Number:2013-004497-10
    Sponsor's Protocol Code Number:CT-P13-3.4
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-02
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2013-004497-10
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.
    A.4.1Sponsor's protocol code numberCT-P13-3.4
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02096861
    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 SponsorCelltrion, Inc.
    B.1.3.4CountryKorea, Republic of
    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 supportCelltrion, Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelltrion, Inc.
    B.5.2Functional name of contact pointSuEun Song
    B.5.3 Address:
    B.5.3.1Street Address13-6 Songdo-dong (same as 23 Academy-ro)
    B.5.3.2Town/ cityYeongsu-gu / Incheon
    B.5.3.3Post code406-840
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82328506724
    B.5.5Fax number+82328506739
    B.5.6E-mailSuEun.Song@celltrion.com
    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 REMSIMA
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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) No
    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.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 Yes
    D.2.1.1.1Trade name REMICADE
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B. V.
    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.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10058815
    E.1.2Term Crohn's disease acute episode
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To demonstrate that CT-P13 (Remsima) is non-inferior to Remicade at Week 6 (Dose 3), in terms of efficacy, as determined by the CDAI-70 response rate
    E.2.2Secondary objectives of the trial
    - To evaluate long-term secondary efficacy of CT-P13 (Remsima) in comparison with Remicade up to Week 54
    - To evaluate overall safety of CT-P13 (Remsima) in comparison with Remicade up to Week 54
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient is a male or female aged 18 to 75 years old, inclusive.
    2.Patient has Crohn's disease of at least 12 weeks’ duration with a score on the CDAI between 220 and 450 points prior to randomization.
    3.Patient has been treated for active Crohn's disease but has not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who is intolerant to or has medical contraindications for such therapies. Patients receiving the following treatments are eligible:
    •5-aminosalicylates or antibiotics (if the dose remained constant for at least 4 weeks prior to randomization)
    •Corticosteroids (prednisone, prednisolone, or budesonide) at the equivalent of 30 mg per day of prednisone or less (stable dose for 2 weeks prior to randomization)
    •Azathioprine (stable dose for 8 weeks prior to randomization)
    •6-mercaptopurine (6-MP) (stable dose for 8 weeks prior to randomization)
    •Methotrexate (MTX) (stable for 6 weeks prior to randomization)
    4.Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
    •Serum creatinine <1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula)
    •Serum alanine aminotransferase <2.5 × ULN
    •Serum aspartate aminotransferase <2.5 × ULN
    •Serum total bilirubin <2 × ULN
    5.Patient has the following hematology laboratory test results at Screening:
    •Hemoglobin ≥8.5 g/dL
    •White blood cell count ≥3.5 × 10ex3 cells/µL (SI [Système International d'Unités] units: ≥3.5 × 10ex9 cells/L)
    •Neutrophil count ≥1.5 × 10ex3 cells/µL (SI units: ≥1.5 × 10ex9 cells/L)
    •Platelet count ≥100 × 10ex3 cells/µL (SI units: ≥100 × 10ex9 cells/L)
    6.Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and/or written instructions, and to comply with the requirements of the entire study.
    7.Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, is given ample time and opportunity to read and understand this information, and has signed and dated the written informed consent before inclusion in the study.
    8.For both male and female patients, the patient and his or her partner of childbearing potential agree to use 2 of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
    •Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
    •Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
    •Intrauterine device
    •Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use 2 medically acceptable methods of contraception.
    •Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
    E.4Principal exclusion criteria
    1.Patient who has previously received a biological agent for the treatment of Crohn's disease.
    2.Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
    3.Patient who has a current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for those infections.
    4.Patient who has an infection requiring oral antibiotics within 2 weeks before randomization, other serious infection within 6 months before randomization, or a history of recurrent herpes zoster or other chronic or recurrent infection within 6 weeks before randomization.
    5.Patient who has a history of TB or a current diagnosis of TB or other granulomatous infections or other severe or chronic infection (such as sepsis, abscess or opportunistic infection, or invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete resolution following treatment.
    6.Patient who has had recent exposure to persons with active TB, or patient who has a positive result to the screening test for latent TB (defined as a positive result for interferon-γ release assay [IGRA] with a negative examination of chest x-ray). A patient with sufficient documentation of prophylaxis or complete resolution following TB treatment based on local guidelines can be enrolled.
    •If the result of the IGRA is indeterminate at Screening, 1 retest will be possible during the screening period. If the repeated IGRA result is again indeterminate, the patient must be excluded from the study. If the repeated IGRA result is negative, the patient may be included in the study.
    •Patients who have a positive result to the IGRA at initial or repeated test with negative examination of chest x-ray during Screening. During Screening, a patient with a positive result for IGRA and a negative examination of chest x-ray who has received at least the first 30 days of country-specific TB therapy and intends to complete the entire course of that therapy can be enrolled.
    7.Patient who is taking any of the following concomitant medications or treatment:
    <Please see Protocol Section 3.3.2 for detailed listing>
    8.Patient who has a medical condition including one or more of the following:
    •Classified as obese (body mass index ≥30 kg/m2)
    •Diabetes mellitus unless on a stable dosing regimen for at least 4 weeks prior to Screening
    •Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg)
    •Active entero-vesical, entero-retroperitoneal, entero-cutaneous, and entero-vaginal fistulae for within 6 months prior to Screening. Entero-enteral fistulae without clinical significant symptoms upon investigator’s opinion and anal fistulae without draining problems are allowed
    •History of short bowel syndrome
    •History of any malignancy within the 5 years prior to randomization except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma
    •History of lymphoma or lymphoproliferative disease or bone marrow hyperplasia
    •New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, arrhythmias, clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction within the 6 months prior to randomization
    •History of organ transplantation, including corneal graft/transplantation
    •Any uncontrolled, clinically significant respiratory disease (in the opinion of the investigator), including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, or pleural effusion
    •Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain Barré syndrome
    •Any conditions significantly affecting the nervous system (ie, neuropathic conditions or nervous system damage)
    •Any other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that may interfere with the interpretation of study results
    9.Patient who has a current or past history of drug or alcohol abuse.
    10.Patient who has had treatment with any other investigational device or medical product within 4 weeks of randomization or 5 half-lives, whichever is longer.
    11.Female patient who is currently pregnant, breastfeeding, or planning to become pregnant or breastfeed within 6 months of the last dose of study drug.
    12.Patient who, in the opinion of his or her general practitioner or the investigator, should not participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The following efficacy parameter for CT-P13 (Remsima) and Remicade will be determined as the primary endpoint:
    • CDAI-70 response at Week 6
    This will be determined in all randomly assigned patients
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 6
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints will be assessed at the time points specified in the schedule of events. The following efficacy parameters for CT-P13 (Remsima) and Remicade will be determined as secondary endpoints:
    • CDAI-70 response
    • Clinical remission
    • SIBDQ

    The following safety parameters for CT-P13 (Remsima) and Remicade will be determined as secondary endpoints:
    • Immunogenicity testing
    • IgE testing
    • Hypersensitivity monitoring via vital sign measurements (including blood pressure, heart and respiratory rates, and temperature
    • Vital sign measurements and weight
    • ECGs
    • Monitoring of TB signs and symptoms
    • Interferon-γ release assay
    • Diabetes mellitus assessment
    • Congestive heart failure assessment
    • Physical examination findings
    • AEs including SAEs
    • Infections
    • Infusion related reactions
    • Clinical laboratory analyses, including ESR and CRP
    • Pregnancy testing
    • Anti-dsDNA testing
    • Concomitant medications
    • Colonoscopy results
    E.5.2.1Timepoint(s) of evaluation of this end point
    evaluations will happen at: weeks 0, 2, 6, 14, 22, 30, 38, 46, 54 and approx. 8 weeks after last dose
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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.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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Canada
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 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: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 214
    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)
    Patients will transition to local standard of care treatment if required in the opinion of the investigator.
    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 Decision2014-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-15
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