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    Summary
    EudraCT Number:2013-004148-49
    Sponsor's Protocol Code Number:B5371002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2013-004148-49
    A.3Full title of the trial
    A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION
    WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY
    ACTIVE RHEUMATOID ARTHRITIS
    A.4.1Sponsor's protocol code numberB5371002
    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 SponsorPfizer Inc.
    B.1.3.4CountryUnited States
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 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 nameInfliximab-Pfizer
    D.3.2Product code PF-06438179
    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 codePF-06438179
    D.3.9.3Other descriptive nameInfliximab-Pfizer
    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.3.9.3Other descriptive nameInfliximab-EU
    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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis is a chronic inflammatory disease causing pain and swelling in the joints. The cause of the disease is unknown. In addition, the disease can involve other tissues of the body.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    To compare the efficacy between infliximab-Pfizer and infliximab-EU in subjects with moderately to severely active RA who are treated with infliximab in combination with methotrexate.
    E.2.2Secondary objectives of the trial
    - To evaluate the overall safety and tolerability of infliximab-Pfizer and infliximab-EU.
    - To evaluate the immunogenicity of infliximab-Pfizer and infliximab-EU.
    - To evaluate the overall safety, tolerability and immunogenicity of infliximab-Pfizer after treatment transition from infliximab-EU to infliximab-Pfizer.
    - To evaluate the population pharmacokinetics (PK) of infliximab-Pfizer and infliximab-EU.
    - To evaluate the pharmacodynamic (PD) response to infliximab-Pfizer and infliximab-EU.
    - To evaluate the individual ACR parameters of clinical response to infliximab-Pfizer and infliximab-EU.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Male and female subjects aged 18 years or older at the time of informed consent. Where required by regulations, consent from a legal representative is required for all subjects who are younger than 20 years of age.
    4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 6 months after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    Female subjects who are not of childbearing potential must meet at least 1 of the following criteria:
    a. Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum FSH level in the laboratory’s reference range for postmenopausal females.
    b. Have undergone a documented hysterectomy and/or bilateral oophorectomy.
    c. Have medically confirmed ovarian failure.
    All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy or bilateral oophorectomy) will be considered to be of childbearing potential.
    5. Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
    classification criteria (see Appendix 1) for RA for at least a 4 month duration.
    6. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA (see Appendix 2).
    7. Moderately to severely active RA disease as defined by the following criteria:
    a. ≥ 6 tender joints (of 68 assessed) at both Screening and Baseline, and
    b. ≥ 6 swollen joints (of 66 assessed) at both Screening and Baseline, and
    c. Hs-CRP ≥10 mg/L (≥1 mg/dL) at Screening, performed by a central
    laboratory. Subjects who do not meet this entry criteria but satisfy all other study entry criteria may have serum hs-CRP concentration re-tested once within 14 days and, if the repeat hs-CRP concentration is ≥10 mg/L
    (≥1 mg/dL), will be eligible to enroll into the study provided all other
    inclusion/exclusion criteria are met.
    8. Stable dose of oral or parenteral methotrexate of 10 to 25 mg/week. Subjects who cannot tolerate 10 to 25 mg/week methotrexate may take a lower dose of as low as 7.5 mg/week (as low as 6 mg/week in geographic regions where specified by local guidance). Subjects must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks prior to first dose of study drug.
    9. Stable dose of oral folic or folinic acid (≥5 mg per week) supplementation for at least 21 days prior to the first dose of study drug.
    10. If receiving an oral corticosteroid, subjects must be on a stable dose of ≤ 10 mg/day of prednisone (or equivalent) for 4 weeks prior to the first dose of study drug, without any intramuscular (IM) or intra-articular (IA) corticosteroids within the 4 weeks prior to the first dose of study drug.
    11. If receiving a NSAID/Cox-2 inhibitor, subject must be on a stable dose of only one NSAID/Cox-2 inhibitor drug for 4 weeks prior to the first dose of study drug at a dosage less than or equal to the maximum recommended dose in the product information. In addition, a cardiovascular dose of aspirin (≤325 mg/day) is permitted. Topical NSAIDs (in addition to one NSAID/Cox-2 inhibitor drug) are allowed, prior to and during the study. Topical NSAIDs should not be used within 24 hours prior to joint assessments.
    E.4Principal exclusion criteria
    1. Pregnant females and breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after last dose of investigational product (IP). Females must not breastfeed for at least 6 months after last dose of IP.
    2. Clinically significant lab abnormalities at Screening, including but not limited to inadequate bone marrow, liver, renal and immune system functions.
    3. Evidence or history of moderate or severe heart failure (NYHA class III/IV, see Appendix 11 for NYHA classification of congestive heart failure) and subjects who are contraindicated for treatment with infliximab in accordance with the approved local label.
    4. Evidence of current or recent history of uncontrolled, clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
    5. Evidence or history of seizures, or nervous system demyelinating diseases.
    6. Evidence or history of a malignancy within the past 5 yrs with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ with no evidence of recurrence.
    7. History of any lymphoproliferative disorder.
    8. History of recurrent (more than one episode) limited herpes zoster or disseminated (a single episode) herpes zoster or herpes simplex. History of disseminated or recurrent infection of EBV or human papilloma virus (HPV) (single, limited episode in the past is not exclusionary).
    9. Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.
    10. History of an infected joint prosthesis at any time.
    11. History of recurrent inflammatory joint disease other than RA (eg, post infectious arthritis, gout, etc.) or history of any other autoimmune rheumatic diseases (eg, vasculopathies, spondyloarthropathies, etc.) other than Sjogren’s syndrome.
    12. Evidence of untreated or inadequately treated latent, or inadequately treated or active infection with tuberculosis (TB). Subjects currently receiving treatment for active or latent TB are excluded.
    13. Chest radiography with evidence of active TB, fungal infections, or other clinically significant abnormalities taken at Screening or within 12 weeks prior to first dose of study drug on Day 1.
    14. Any current or prior treatment for the following DMARDs within the relevant washout period.
    15. Current or prior treatment with infliximab or lymphocyte depleting therapies (eg, Rituximab, Campath). Prior exposure to biologic therapy for RA (with the exception of up to 2 doses of one biologic therapy for RA, including anti-TNF therapies (other than infliximab). For prior exposure to a biologic therapy for RA, a washout period of at least 12 weeks or 5 half lives(whichever is longer) is required prior to the first dose of the study drug.
    16. Known requirement for treatment with prohibited concomitant medications during study.
    17. Significant trauma or surgical procedure within 4 wks prior to 1st dose of study drug.
    18. Known or Screen test positive human immunodeficiency virus (HIV) hepatitis B virus (HBV), or hepatitis C virus (HCV).
    19. Screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results.
    20. Positive urine drug test at Screening for substances of abuse that is not due to prescribed medication.
    21. Past or current history of addiction or dependence on non-prescribed substances within 12 months prior to Screening.
    22. History of allergic or hypersensitivity reaction to active or inactive components of the study drug or any murine, chimeric or human proteins.
    23. Exposure to any live vaccines within 4 weeks prior to administration of the first dose of study drug or lack of willingness to avoid exposure to any live vaccines during the trial and for at least 3 months after the last dose of study drug.
    24. Participation in other studies involving investigational drug(s) (Phase 1-4) within at least 4 wks or 5 half-lives from last dose, whichever is longer, before the current study begins and/or during study participation.
    25. Other severe acute or chronic medical or psychiatric condition or lab abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    (Shortened. For full exclusion criteria refer to protocol section 4.2)
    E.5 End points
    E.5.1Primary end point(s)
    ACR20 response (≥ 20% improvement by ACR criteria) at Week 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 14. In addition, point estimates and 95% CIs in difference of
    ACR20 response rates between the two treatment arms at Weeks 2, 4, 6, 12, 22, and 30, will be used to support the primary efficacy analysis.
    E.5.2Secondary end point(s)
    - Categorical and continuous measures of clinical efficacy, including ACR20 (other than Week 14), ACR50, ACR70, change in DAS28-CRP (Disease Activity Score-28 4 components based on CRP), DAS remission (≤2.6), EULAR (European League Against Rheumatism) response, ACR/EULAR remission, and change in HAQ-DI.
    - Safety measures characterized by type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities.
    - Change from baseline in individual components of ACR response.
    - Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab) in response to infliximab-Pfizer and infliximab-EU.
    - Serum drug concentrations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Week 14 and other protocol-defined time points up to Week 30.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Biosimilar
    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.8.2.4Number 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 Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Argentina
    Australia
    Bosnia and Herzegovina
    Brazil
    Canada
    Colombia
    European Union
    Georgia
    Guatemala
    Israel
    Japan
    Korea, Republic of
    Mexico
    Morocco
    Peru
    Philippines
    Russian Federation
    Serbia
    South Africa
    Tunisia
    Ukraine
    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
    End of Trial in all participating countries is defined as Last Subject Last Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 462
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 152
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 614
    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)
    None
    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 Decision2014-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-01
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