Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-018646-31
    Sponsor's Protocol Code Number:CT-P13-3.1
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-07
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2010-018646-31
    A.3Full title of the trial
    A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberCT-P13-3.1
    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 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 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 nameCT-P13
    D.3.2Product code CT-P13
    D.3.4Pharmaceutical form Powder for 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 INNInfliximab
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    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 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 typeMono-cloncal 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 Yes
    D.2.1.1.1Trade name Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor BV
    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
    D.3.4Pharmaceutical form Powder for 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 INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeRemicade
    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 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 typeMono-cloncal antibody
    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
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 primary objective of this study is to demonstrate that CT P13 is equivalent to Remicade up to Week 30, in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20).
    The study will be unblinded at Week 30 for reporting, but will remain blinded to the investigators and patients until the end of the study.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate long term efficacy, pharmacokinetics, pharmacodynamics, and overall safety of CT P13 in comparison with Remicade reference product up to Week 54.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female aged 18 to 75 years old, inclusive.
    2. Patient was diagnosed with active RA according to the revised 1987 ACR classification criteria [Arnett et al 1987] for at least 1 year prior to Screening.
    3. Patients have active disease as defined by the presence of 6 or more swollen joints, and 6 or more tender joints, and at least two of the following: morning stiffness lasting at least 45 minutes, an erythrocyte sedimentation rate greater than 28 mm/h, and a serum C reactive protein (CRP) concentration greater than 2.0 mg/dL (Maini et al 1999).
    4. Patients who have completed at least 3 months of treatment of oral or parenteral dosing with methotrexate between 12.5 to 25 mg/week and on stable dosing with methotrexate between 12.5 to 25 mg/week for at least 4 weeks prior to Screening.
    5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings), and intrauterine devices) during the course of the study and for 6 months following discontinuation of study treatments (excluding women who are not of childbearing potential and men who have been sterilized).
    6. Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to study entry must agree to use 2 medically accepted methods of contraception as per inclusion criterion 5.
    7. Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
    8. Patients have adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
    • Serum creatinine <1.7 × upper limit of normal (ULN) or an estimated creatinine clearance level >75 mL/min
    • Serum alanine aminotransferase <2 × ULN
    • Serum aspartate aminotransferase <2 × ULN
    9. Patients have the following hematology laboratory test results at Screening:
    • Hemoglobin ≥8.0 g/dL
    • White blood cell count ≥3.5 × 103 cells/µL (SI [Système International d’Unités] units: ≥3.5 × 109 cells/L)
    • Neutrophil count ≥1.5 × 103 cells/µL (SI units: ≥1.5 × 109 cells/L)
    • Platelet count ≥100 × 103 cells/µL (SI units: ≥100 × 109 cells/L)
    10. Patients are permitted to receive both oral glucocorticoids equivalent to ≤10 mg daily prednisolone and nonsteroidal anti-inflammatory drugs, if they have received a stable dose for at least 4 weeks prior to Screening. In addition, patients are permitted to receive low potency topical, otic, and ophthalmic glucocorticoid preparations provided the preparations are administered per the instructions on the product label.
    11. Patients have 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 written instructions, and to comply with the requirements of the entire study.
    12. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information, signed and dated the written informed consent before inclusion in the study.
    E.4Principal exclusion criteria
    1. Patients who have previously been administered a biological agent for the treatment of RA.
    2. Patients who have allergies to any of the excipients of infliximab or any other murine and human proteins and patients with a hypersensitivity to immunoglobulin product.
    3. Patients who have a current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus 1 or 2 or who have a positive result to the screening test for those infections.
    4. Patients who have a current diagnosis of tuberculosis (TB) or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, or invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete resolution following treatment.
    5. Patients who have had recent exposure to persons with active TB, or who have a positive result to the screening test for latent TB defined as a positive result of interferon-γ release assay with a negative examination of chest x-ray, and who have not received at least the first 30 days of country-specific TB therapy and do not intend to complete the entire course of that therapy. Patients with an abnormal chest x ray must be discussed with the medical monitor before randomization.
    6. Patients who have had an infection requiring oral antibiotics in the 2 weeks before Screening, parenteral injection of antibiotics in the 4 weeks before Screening, or other serious infection in the 6 months before Screening or who have a history of recurrent herpes zoster or other chronic or recurrent infection
    7. Patients who have a current or past history of drug or alcohol abuse.
    8. Patients who have a medical condition including one or more of the following:
    • Classified as obese
    • Bone marrow hypoplasia
    • Diabetes mellitus unless on a stable dosing regimen for at least 4 weeks prior to Screening
    • Hypertension at Screening
    • Any other inflammatory or rheumatic diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, systemic lupus erythematosus, Lyme disease, or fibromyalgia, that may confound the evaluation of the effect of the study drug.
    • History of any malignancy within the previous 5 years 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
    • History of congestive heart failure (New York Heart Association class III/IV) or unstable angina
    • History of organ transplantation
    • History of severe hypersensitivity
    • Severe physical incapacitation (unable to perform routine self care, has RA ACR functional status class 4 [Arnett et al 1988], or who cannot benefit from medication)
    • Any clinically significant respiratory disease, 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 Barre syndrome
    • Any conditions significantly affecting the nervous system (ie, neuropathic conditions or nervous system damage) if it may interfere with the investigator’s assessment on disease activity scores including joint counts
    • 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. Patients taking any of the following concomitant medications:
    • Corticosteroids, except oral glucocorticoids, of maximum equivalent daily dose of 10 mg of prednisolone within 4 weeks prior to Screening. (Patients are permitted to receive low potency topical, otic, and ophthalmic glucocorticoid preparations provided the preparations are administered per the instructions on the product label.)
    • Disease-modifying antirheumatic drugs, other than methotrexate, including hydroxychloroquine, chloroquine, or sulfasalazine, within 4 weeks prior to Screening. Patients who discontinued leflunomide and have had successful chelation with 8 g of cholestyramine (3 times daily) for 11 days must wait 4 weeks prior to Screening. Patients who discontinued leflunomide and did not have cholestyramine washout must wait 12 weeks after last dose leflunomide before Screening.
    • Alkylating agents within 12 months prior to Screening
    • Live or live-attenuated vaccine within 8 weeks of Screening
    • Any biological agents for the treatment of RA
    10. Patients who have participated in a study with an investigational drug within 6 months of Screening or who are currently receiving treatment with any other investigational drug or device.

    For exclusion criteria 11 to 13 please refer to protocol CT_P13 3.1 v5
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the proportion of patients achieving clinical response according to the ACR20 criteria at Week 30. A patient is defined as a responder according to ACR20 criteria if the following are fulfilled:
    •A decrease of at least 20% in the number of tender joints
    •A decrease of at least 20% in the number of swollen joints and
    •A 20% improvement in three of the following:
    •Patient’s assessment of pain on the VAS
    •Patient and physician global assessment of disease status (VAS)
    •Health assessment questionnaire estimate of physical ability
    •Serum CRP concentration
    •ESR

    The VAS range is from 0 to 100 mm, with higher scores indicating poorer status or more severe pain.

    For the derivation of ACR20 at Week 30 the following categories of patients are considered nonresponders:
    •Patients with an improvement according to the ACR criteria of less than 20%
    •Patients who discontinue the study prior to Week 30 except for safety reasons
    •Patients with missing or incomplete data for the evaluation of ACR20 at Week 30
    •Patients with protocol prohibited changes in medication including initiation therapy with a new DMARD, increase in dose of RA medication (methotrexate or corticosteroid) and administration of intra articular corticosteroids in more than 1 joint
    •Patients requiring a surgical joint procedure during the study

    This approach should also be used for other time points where ACR20 is derived.
    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 Yes
    E.6.8Bioequivalence Yes
    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 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.8.3 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 EEA91
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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) 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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 584
    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 Decision2010-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-10
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA