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    Summary
    EudraCT Number:2007-000593-24
    Sponsor's Protocol Code Number:PP20899B
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-11-21
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-000593-24
    A.3Full title of the trial
    An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.
    A.4.1Sponsor's protocol code numberPP20899B
    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 SponsorF.Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    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 and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEtanercept
    D.3.9.1CAS number 185243-69-0
    D.3.9.3Other descriptive nameEnbrel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Information not present in EudraCT
    D.IMP: 2
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.3Other descriptive nameHumira
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Information not present in EudraCT
    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 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 compare (i) baseline characteristics and (ii) changes over time in
    a) Ultrasonographic imaging of a discrete joint set including the joints selected for synovial biopsy
    b) Synovial tissue histology and immunohistochemistry (inflammation and phosphoprotein markers)
    c) Peripheral blood biomarkers of inflammation and tissue repair.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to investigate the relationship between synovial pathology and ultrasonographic imaging parameters and to explore possible correlations between clinical efficacy and biologic effects of anti-TNF therapy on peripheral blood and synovial tissue biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: Group A Only
    1a. Naïve to either etanercept or adalimumab, or who may have received prior anti-TNF therapy and displayed an intolerance but is now considered to be appropriate candidate for treatment with either etanercept or adalimumab.

    Inclusion Criteria: Group B Only
    1b. History (as documented in the patient’s medical records) of initial clinical response to either etanercept or adalimumab and a subsequent loss of clinical response. Initial clinical response is defined as attainment of Good or Moderate response by EULAR criteria during the first 3 months of anti-TNF therapy; the consistency of the response must be documented on at least
    two consecutive occasions separated by at least 4 weeks. Loss of response to therapy is defined as DAS 28 score ≥ 4.5 and increase or worsening in DAS 28 by ≥ 1.2 from lowest DAS achieved on anti-TNF therapy, in at least two consecutive
    evaluations separated by at least 4 weeks. A documented loss of response is required prior to study screening. Confirmation of loss of response will occur at the Screening Visit.

    Inclusion Criteria: Groups A and B

    Able and willing to give written informed consent and comply with the requirements of the study protocol.
    Diagnosis of RA at least 3 months prior to start of anti-TNF therapy, according to the revised 1987 ACR criteria.
    Age 18–80 years, inclusive.
    If on corticosteroids, dose must be ≤ 10 mg prednisone (or equivalent) for at least 2 weeks prior to baseline assessment.
    Must have inadequate response to MTX at a dose of 10-25 mg/week (po or parenteral) for ≥ 12 weeks, of which the 4 weeks immediately prior to the baseline visit have been at a stable dose.
    Swollen joint count (SJC) ≥ 4 (28 joint count), and tender joint count (TJC) ≥ 4 (28 joint count) at baseline.
    At screening, either; CRP ≥ 0.6 mg/dL (6 mg/L) with high sensitivity assay OR ESR ≥ 28 mm/h.
    At least one active joint that is appropriate for biopsy.
    Positive for rheumatoid factor (RF) or anti-CCP.
    If female, and of child bearing potential, must agree to use a reliable form of contraception (eg.hormonal contrceptive, patch, intra-uterine device, physical barrier) during the study and for 5 months following the last dose of prescribed anti-TNF therapy.
    If male, must agree to use(with his partner) a reliable form of contraception (hormonal contrceptive, patch, intra-uterine device, physical barrier method), during the study and for 5 months following the last dose of prescribed anti-TNF therapy
    E.4Principal exclusion criteria
    Exclusion Criteria: Groups A and B
    Patients with any of the following will be excluded from the study:
    Any contraindication for entanercept or adalimumab treatment according to the approved product label.
    Pregnant or Breast feeding
    History of or current inflammatory joint disease or autoimmune disease other than RA.
    Treatment with sulfasalazine, hydroxychloroquine, chloroquine,D-penicillamine, auranofin, azathioprine, cyclosporine, or tacrolimus ≤ 4 weeks prior to baseline, or abatacept or leflunomide ≤ 8 weeks before baseline.
    Treatment with any investigational agent ≤ 4 weeks prior to baseline or < 5 half-lives of the investigational drug or where persisting PD effect (eg, cell depletion) of investigational therapy on target cells or pathways to RA (whichever is longer). Previous treatment with alkylating agents or cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti-CD11a, Blys, BAFF, anti-CD22 and anti-CD20).
    Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
    Intra-articular or parenteral corticosteroids ≤ 2 weeks prior to
    baseline.
    Intra-articular treatment of the joint selected for biopsy within 3 months of baseline visit.
    History of heart failure.
    Evidence of significant uncontrolled concomitant diseases such
    as neurological, cardiovascular, renal, hepatic, endocrine, or gastrointestinal disorders which, in the opinion of the investigator, would preclude patient participation.
    E.5 End points
    E.5.1Primary end point(s)
    to compare (i) baseline characteristics and (ii) changes over time in:
    a) Ultrasonographic imaging of a discrete joint set including the
    joints selected for synovial biopsy
    b) Synovial tissue histology and immunohistochemistry
    (inflammation and phosphoprotein markers).
    c) Peripheral blood biomarkers of inflammation and tissue repair.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Post Marketing
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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
    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.1.3Elderly (>=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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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 Decision2008-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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