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    Summary
    EudraCT Number:2019-000284-24
    Sponsor's Protocol Code Number:B5381012
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-17
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-000284-24
    A.3Full title of the trial
    A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.
    RANDOMIZOVANÁ SROVNÁVACÍ STUDIE HODNOTÍCÍ ZAMĚNITELNOST PŘÍPRAVKŮ PF-06410293 A HUMIRA® V KOMBINACI S METHOTREXÁTEM U ÚČASTNÍKŮ SE STŘEDNĚ TĚŽKOU AŽ TĚŽKOU AKTIVNÍ REVMATOIDNÍ ARTRITIDOU
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.
    A.4.1Sponsor's protocol code numberB5381012
    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 Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street,
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1800718 1021
    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 nameAdalimumab-Pfizer
    D.3.2Product code PF-06410293
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdalimumab
    D.3.9.2Current sponsor codePF-06410293
    D.3.9.4EV Substance CodeSUB129253
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeADALIMUMAB HUMIRA
    D.3.9.3Other descriptive nameADALIMUMAB HUMIRA
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 3
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH Co. KG
    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 Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeADALIMUMAB HUMIRA
    D.3.9.3Other descriptive nameADALIMUMAB HUMIRA
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Moderately to severely active Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis is broadly referred to as joint inflammation and has different stages of disease progression. This study is for patients with moderate to severe Rheumatoid Arthritis.

    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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 evaluate interchangeability of PF-06410293 and Humira by examining adalimumab steady state pharmacokinetics in a switching arm (following 3 switches between Humira and PF-06410293) as compared to a non-switching arm (receiving only Humira).
    E.2.2Secondary objectives of the trial
    • To evaluate other serum adalimumab PK parameters in the switching arm and the non switching arm.
    • To evaluate the overall safety and tolerability of the switching arm and the non-switching arm.
    • To evaluate immunogenicity of the switching arm and the non-switching arm.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:

    Age and Sex:
    1. Male or female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at Visit 1 (Screen 1). Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.

    Type of Participant and Disease Characteristics:
    2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    3. Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA for at least a 4 month duration.
    4. Moderately to severely active RA disease based on local standard of care.
    5. Must have received oral, subcutaneous (SC), or intramuscular (IM) methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to first dose of investigational product on Day 1 of TP1. The stable dose must be 10 to 25 mg per week, with the exception of 6 to 25 mg per week where 6 mg per week is a recommended initial dose by local guidance or standard of care.
    6. Stable dose of oral folic acid (at least 1 mg/day on ≥5 days per week) or oral folinic acid (≥5 mg once per week) supplementation for at least 21 days prior to the first dose of investigational product on Day 1 of TP1. In countries which do not have approved folic acid 1 mg or folinic acid 5 mg presentations, a regimen of folic acid of ≥5 mg weekly is acceptable.
    7. Prior lymphocyte depleting therapies (eg, rituximab, Campath) must have normal lymphocyte counts at the time of screening and no remaining depletion is documented.

    Weight:
    8. Body mass index (BMI) of 18 to 45 kg/m2 and a total body weight of ≥40 kg (88 pounds) to ≤130 kg (287 pounds).
    Informed Consent:
    9. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
    E.4Principal exclusion criteria
    1. Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome)
    2. History of seizure disorder requiring treatment in the previous 5 years prior to Screening
    3. History of active or significant infection defined by:
    a. History of recurrent (more than one episode) limited herpes simplex which requires current chronic antiviral therapy, or disseminated (a single episode) herpes simplex.
    b. History of disseminated or recurrent infection with Epstein Barr virus (EBV), human papilloma virus (HPV), or varicella zoster. A single, limited episode in the past is not exclusionary
    c. Any infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of investigational product
    d. History of an infected joint prosthesis at any time, with the prosthesis still in situ
    e. SARS-CoV2 infection (COVID-19) should be considered clinically significant, local guidelines on COVID-19 and medical judgement should be followed
    f. Any other active infection considered to be clinically significant as assessed by the investigator
    4. Known or Screen test confirmed positive for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C (HCV) virus
    a. Positive for HIV.
    b. Positive hepatitis B surface antigen (HBsAg)
    c. Positive hepatitis B core antibody (HBcAb) without positive hepatitis B surface antibody (HBsAb) (unless it is documented that hepatitis B DNA test is negative)
    d. Positive hepatitis C antibody (HCV Ab) results and positive confirmatory HCV riboneucleic acid (HCV RNA) results.
    5. Evidence of current or recent history of uncontrolled, clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, infectious, psychiatric, neurologic, allergic, or cardiovascular disease including evidence or history of moderate or severe heart failure (NYHA Class III/IV) or Screening 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities which may affect participant safety, and participants who are contraindicated for treatment with adalimumab in accordance with the approved local label
    6. History of any lymphoproliferative disorder (eg, EBV related lymphoproliferative disorder, lymphoma, or leukemia). Evidence or history of a malignancy within the past 5 years (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 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.
    8. Significant trauma or surgical procedure within 4 weeks prior to first dose of investigational product.
    9. History of severe allergic or hypersensitivity or anaphylactic reaction to a biologic drug or to active or inactive components of the investigational product.
    10. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
    11. Prior/Current treatment with adalimumab.
    12. More than 3 disease modifying anti rheumatic drugs (DMARDs) in combination therapy; concomitant DMARD therapy including small molecules, biologics, and biosimilars, with the exception of methotrexate and stable dose (at least 4 weeks) of leflunomide, anti-malarials and sulfasalazine
    13. Prior lymphocyte depleting therapies (eg, rituximab, Campath) with remaining lymphocyte depletion
    14. Known requirement for treatment with prohibited concomitant medications during the study
    15. Exposure to any live vaccines within 4 weeks prior to administration of the first dose of investigational product, or lack of willingness to avoid exposure to any live vaccines during the trial and for at least 2 months after the last dose of investigational product
    16. Intra- articular (IA) corticosteroids administered within 4 weeks prior to Screening
    17. Unstable dose (less than 4 weeks) of oral and IM corticosteroid prior to first study dose
    18. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or within 5 half lives preceding the first dose of investigational product used in this study (whichever is longer) is not permitted

    Please refer to section 5.2 of the protocol for a full list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Maximum observed concentration (Cmax) and area under the concentration - time curve over the dosing interval (AUCt) obtained during the intensive PK sampling interval.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint data will be supported by the determination of adalimumab drug concentrations for the 2 week PK Profile.

    PK samples will be collected throughout visits 1-12.

    Please refer to the clinical trial protocol for more information. Table 1 in the protocol (PK Sampling Table) provides the full PK schedule.
    E.5.2Secondary end point(s)
    • Other serum adalimumab PK parameters, including time at which Cmax occurs (Tmax), average concentration (Cav), and apparent clearance (CL/F) obtained during the intensive PK sampling interval and predose concentration during multiple dosing (Ctrough) obtained at scheduled PK sample timpoints.
    • Safety measures characterized by type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events (AEs) and laboratory test abnormalities.
    • Percent of participants with antidrug antibodies (ADA), and neutralizing antibodies (NAb) ADA/NAb and ADA/NAb titers over time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK samples will be collected throughout visits 1-12.
    Please refer to the clinical trial protocol for more information. Table 1 in the protocol (PK Sampling Table) provides the full PK schedule.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Bosnia and Herzegovina
    Bulgaria
    Czech Republic
    Lithuania
    Poland
    Russian Federation
    Serbia
    South Africa
    Ukraine
    United States
    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
    The end of the study is defined when the last participant in the trial completes the date of last scheduled visit or contact as shown in the Schedule of Activities.

    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 207
    F.4.2.2In the whole clinical trial 420
    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)
    This is a research study, the study drug, PF-06410293 and the study defined medical care will only be given to the subjects during the study, unless subjects experience adverse events which require appropriate follow-up.
    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 Decision2020-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
    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
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