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    Summary
    EudraCT Number:2015-001954-14
    Sponsor's Protocol Code Number:1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-001954-14
    A.3Full title of the trial
    SIMILAR Trial: Santeon InflixMab biosimILAr Research
    A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission.
    Een gerandomiseerde, gecontroleerde, dubbelblinde, fase 4 non-inferioriteit pad, om de effectiviteit van CT-P13 te beoordelen en te vergelijken met infliximab, bij patiënten met een inflammatoire darmziekte die in remissie zijn.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”
    “Werkzaamheid en veiligheid van Infliximab-biosimilar (Inflectra) in vergelijking met Infliximab-innovator (Remicade) bij patiënten met IBD in remissie: de SIMILAR Trial”
    A.3.2Name or abbreviated title of the trial where available
    SIMILAR Trial: Santeon InflixMab biosimILAr Research
    A.4.1Sponsor's protocol code number1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02452151
    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 SponsorSanteon
    B.1.3.4CountryNetherlands
    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 supportSanteon
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOnze Lieve Vrouwe Gasthuis
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressOosterparkstraat 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1091 AC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205999111
    B.5.6E-mailj.m.jansen@olvg.nl
    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 Inflectra 100 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    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.3.1Product nameInflectra 100 mg powder for concentrate for solution for infusion
    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.3.11 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) Yes
    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 100 mg powder for concentrate for solution for infusion.
    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.3.1Product nameRemicade 100 mg powder for concentrate for solution for infusion.
    D.3.2Product code EMEA/H/C/000240
    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.3.11 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) Yes
    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
    ulcerative colitis and Crohn’s disease
    colitis ulcerosa en de ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    ulcerative colitis, Crohn’s disease
    colitis ulcerosa en de ziekte van Crohn
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn’s disease in remission under treatment with infliximab for at least 12 weeks.
    E.2.2Secondary objectives of the trial
    - Evaluation of adverse effects and overall safety of Infliximab-biosimilar in comparison with Infliximab-innovator up to 30 weeks.
    - Evaluation of pharmacokinetics of Infliximab-biosimilar in comparison with Infliximab-innovator up to 30 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    1. Patient, male or female, is aged above 18 years.
    2. Patient has an established diagnosis of ulcerative colitis or Crohn’s disease.
    3. Patient has ulcerative colitis or Crohn’s disease in clinical and endoscopic remission defined as:
    a. Crohn’s disease: HBI score <5 with a fecal calprotectin <250 mg/g.
    b. Ulcerative colitis: total Mayo score of ≤2 with a fecal calprotectin <250 mg/g.
    4. Patient is being treated with Infliximab 5mg/kg to 10mg/kg with stable dosing intervals between 6 to 10 weeks for at least 12 weeks.
    5. Patient may receive one of the following treatments:
    a. 5-aminosalicylates (no dosage changes for at least 8 weeks for inclusion)
    b. Antibiotics
    c. Azathioprine, 6-mercaptopurine (6-MP) or tioguanine (6-TG) (no dosage changes for at least 8 weeks for inclusion)
    d. Methotrexate (MTX) (no dosage changes for at least 8 weeks for inclusion)
    6. Patient has stable renal and hepatic function at time of screening, defined as:
    a. Serum creatinine <1.5 x upper limit of normal (ULN) or an estimated creatinine clearance level >50mL/min
    b. Serum alanine aminotransferase <2.5 x ULN
    c. Serum aspartate aminotransferase <2.5 x ULN
    d. Serum total bilirubin <2 x ULN
    7. Patient has the following hematology laboratory test results at time of screening:
    a. Hemoglobin ≥5.5mmol/l
    b. White blood cell count: ≥3.5 x 109 cells/l
    c. Neutrophil count: ≥1.5 x 109 cells/l
    d. Platelet count: ≥100 x 109 cells/l
    8. Patient is able to understand the intention, the nature and the possible risks of the study, to cooperate with the investigator and to understand given instructions.
    9. Patient is informed about the intention and nature of the study including all possible risks and has given his written consent before inclusion.
    10.
    a. Female patients of child of childbearing potential agree to use 1 of the following medically acceptable methods of contraception during the course of the study and for 12 weeks following discontinuation of study drug (excluding women who are not of childbearing potential or who have been sterilized):Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
    b. Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
    c. Intrauterine device.
    Female patients who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use 1 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
    A potential subject who meets any of the following criteria will be excluded from participation in this study:

    1. Patient has an allergy or hypersensitivity to one of the components of infliximab and/or immunoglobulin products, except hypersensitivity reactions which have a positive response to hydrocortisone and thereby are under control.
    2. Patient has a history of tuberculosis (TB) or a current diagnosis of TB or other severe or chronic infection such as abscess, opportunistic infection or invasive fungal infection. Patients with a past history of a severe or chronic infection will not be excluded.
    3. Patient has had recent exposure to persons with active TB. In that case screening for latent TB (defined as a positive result for interferon-γ release assay (IGRA) with a negative examination of chest X-ray) will be performed. If there is sufficient documentation of prophylaxis or complete resolution following TB-treatment based on hospital-specific guidelines the patient can be enrolled. If the result of the IGRA is indeterminate at screening, 1 retest will be done. If the repeated IGRA result is indeterminate again, the patient will be excluded. Patients with a positive IGRA result and a negative examination of chest X-ray who has received at least the first 30 days of TB-therapy can be enrolled.
    4. Patient who is taking any of the following concomitant medications or treatment:
    a. Current use of corticosteroids (prednisone, prednisolone or budesonide).
    b. Alkylating agents: current use or within 12 months to randomization
    c. Live or live-attenuated vaccine within 8 weeks of randomization.
    d. Any other biological treatments than infliximab.
    e. Any planned abdominal surgery for IBD at the time of randomization and/or during the study period.
    5. Patient has one or more of the following medical conditions:
    a. Active entero-vesical, entero-retroperitoneal, entero-cutaneous and entero-vaginal fistula 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.
    b. Current short bowel syndrome.
    c. History of any malignancy within the 5 years prior to randomization except cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma or completely excised and cured squamous carcinoma of the uterine cervix.
    d. History of lymphoma or lymphoproliferative disease or bone marrow hyperplasia.
    e. New York Heart Association (NYHA) class III or IV heart failure.
    f. History of organ transplantation, including corneal graft/transplantation.
    g. Ileostomy of colostomy.
    6. Patient has had treatment with any other investigational device or medical product within 4 weeks of randomization or 5 half-lives, whichever is longer.
    7. Female patient who is currently pregnant, breastfeeding, or planning to become pregnant or breastfeed within 12 weeks of the last dose of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    Relapse rate:
    The primary endpoint relapse is in CD defined as a SES-CD score >2 and in UC as a Mayo endoscopy score of ≥2. In patients with only small bowel involvement a MRI will used to evaluate disease activity. If an exacerbation, and therefore a relapse is proven by colonoscopy or MRI, dose escalation or change of treatment will be considered as is standard care. A colonoscopy will be performed in case of worsening of symptoms in combination with a fecal calprotectin >250 mg/g. Worsening of symptoms is defined in CD as an increase in HBI of ≥ 4 points from baseline and a minimum HBI score of 7 points and in UC as an increase in partial Mayo score of ≥ 3 points from baseline and a minimum partial Mayo score of ≥ 5 points.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patiënts will be evaluated for the primary end point up to 30 weeks after randomisation.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    • SIBDQ scores
    • Pharmacokinetic evaluation

    Secondary safety endpoints
    • Adverse and serious adverse events
    • Assessment and monitoring of TB signs and symptoms.
    • Physical Examination findings
    • Clinical laboratory analyses, including calprotectin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation at screening:
    Clinical laboratory analyses, latent TB screening, HBI/Mayo scores, SIBDQ, Physical Examination, Vital signs and Weight, Calprotectin,

    Evaluation at the first and last study drug administration and in case of relapse:
    Immunogenicity testing
    Pharmacokinetic blood sampling

    Evaluation at each visit from (and including) baseline to (and including) end of study at 30 weeks. The visits will be carried out according to the patient’s pre-randomization innovator infliximab treatment schedule, i.e. ranging from every 6 to 10 weeks.
    Physical Examination
    Vital signs and Weight
    Adverse and serious adverse events
    Hypersensitivity testing
    TB clinical monitoring
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Non-inferiority
    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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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 No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state182
    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)
    All patients will be given the opportunity to continue the study medication and will be asked to enroll in an open-label follow up trial. The objective of this study is to assess the non-inferiority in efficacy of Infliximab-biosimilar compared to Infliximab-innovator in a long-term setting. If treated with Infliximab-biosimilar the patient can choose to switch back to Infliximab-innovator. Depending on the dosing regimen of the patient, every 6-10 weeks the patient will have a follow-up visit.
    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 Decision2015-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-14
    P. End of Trial
    P.End of Trial StatusOngoing
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