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    Summary
    EudraCT Number:2006-004140-23
    Sponsor's Protocol Code Number:27298
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-04
    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 ConcernedGreece - EOF
    A.2EudraCT number2006-004140-23
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy
    A.3.2Name or abbreviated title of the trial where available
    A Phase II dose-finding study of atacicept in RA
    A.4.1Sponsor's protocol code number27298
    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 SponsorMerck Serono International S.A.
    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 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 nameAtacicept
    D.3.2Product code Not Applicable
    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 INNAtacicept
    D.3.9.3Other descriptive nameTACI-Fc5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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 8.1
    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
    To evaluate the efficacy of three dose levels of atacicept in the treatment of signs and symptoms of subjects with active rheumatoid arthritis (RA) who have had an inadequate response to previous TNFalfa antagonist therapy.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability profile of atacicept in the treatment of subjects with active RA.
    - To evaluate the exposure-response relationship of atacicept with respect to efficacy and safety in subjects with active RA.
    - To gain further information on the effect of atacicept on relevant markers of its mechanism of action and of disease activity.
    - To further characterise the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of atacicept.
    - The following exploratory objectives may also be addressed (pharmacogenetic analyses will be performed after trial completion only if it is believed that they may benefit the further development of atacicept):
    - To identify association between gene polymorphisms and drug response, with a focus on BLyS, APRIL, BAFF-R, TACI, BCMA and HLA-DRB1.
    - To identify association between gene expression profiles before and after treatment with drug response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion into this trial, subjects must fulfil all of the following criteria at the time of screening, unless stated otherwise:
    1. Rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria, with a disease history of at least one year.
    2. Male or female >or=18 years of age at time of Informed Consent.
    3. Active RA as defined by:
    - >or= 8 swollen joints (66-joint count),
    - >or= 8 tender joints (68-joint count), and
    - CRP >or=10 mg/L (central laboratory).
    4. Failure of at least one TNFa antagonist therapy (previously or at the time of screening), defined as having persistent disease activity with a minimum of 8 swollen and 8 tender joints despite treatment with etanercept, infliximab or adalimumab at an approved labelled dose for >or= 3 months. Subjects who have discontinued TNFa antagonist therapy due to intolerance without associated lack of efficacy are not considered to satisfy this criterion.
    Subjects with previous treatment failure must have documentation of the treatment failure provided by the treating physician, with a similar benchmark of minimally acceptable disease severity.
    5. Current use of at least one DMARD at a stable dose, defined by use for at least 3 months before SD 1 with no changes in dosing regimen in the 28 days before Study Day 1 (SD 1, defined as the day of randomisation and first Investigational Product administration).
    6. Rheumatoid factor (RF) positivity according to central laboratory criteria.
    7. Written informed consent (obtained before any trial-related procedure). Subjects must review and understand the Informed Consent Form, and must fully understand requirements of the trial and be willing to comply with all trial visits and assessments.
    8. For women, willingness to use adequate double contraception (i.e., two independently effective methods) for 4 weeks before randomisation and during the trial and for 3 months after the trial. These requirements do not apply to women who are surgically sterile or sexually inactive or who are post-menopausal for at least one year.
    9. For women of childbearing potential or for those who are post-menopausal for less than one year, a negative urine pregnancy test.
    E.4Principal exclusion criteria
    To be eligible for inclusion in this trial, the subjects must not meet any of the following criteria at the time of screening:
    1. Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject’s participation to the trial or that could interfere with the trial objectives, conduct or evaluation.
    2. Treatment with rituximab within 2 years before SD 1.
    3. Any previous treatment with abatacept or belimumab.
    4. Use of etanercept within 28 days before SD 1, or of infliximab or adalimumab within 60 days before SD 1.
    5. Participation in any interventional clinical trial within the 6 months before SD 1 (or within 5 half-lives of the investigated compound before SD 1, whichever is longer).
    6. Methotrexate dose regimen > 25 mg/week.
    7. Prednisone dose regimen > 10 mg/day (or equivalent) or change in steroid dosing regimen within 28 days before SD 1.
    8. Change in NSAID dosing regimen within 28 days before SD 1.
    9. Any current active infection, including herpes zoster or Epstein-Barr virus.
    10. Positive HIV, hepatitis B or hepatitis C serology.
    11. History or presence of active or latent tuberculosis as defined by national recommendations.
    12. Opportunistic infection in the last 3 months.
    13. History of chronic infections requiring repeated antibiotic treatment.
    14. Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).
    15. History or presence of uncontrolled or New York Heart Association class 3 or 4 congestive heart failure.
    16. History of cancer, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia or carcinoma in situ of the skin or cervix.
    17. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (AP) level > 2.5 x ULN or total bilirubin > 1.5 x ULN.
    18. Inadequate renal function, defined by serum creatinine > 1.5 x ULN.
    19. Clinically significant abnormality in any haematological test (for example, haemoglobin < 5.5 mmol/L, WBC < 2.5 x 109/L, platelets < 75 x 109/L).
    20. Serum IgG, IgA or IgM below the lower limits of normal as defined by the central laboratory.
    21. Clinically significant abnormality on a chest X ray performed within 3 months before SD 1 or on ECG performed at screening.
    22. Hypersensitivity to any of the components of the formulated atacicept or to structurally similar compounds.
    23. Immunisation with live vaccines or Ig treatment within one month before SD 1 or need for such treatment during the trial period (including follow-up).
    24. Planned major surgery (e.g., joint replacement) during the trial period (including follow-up).
    25. Breastfeeding (for female subjects).
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects achieving an ACR20 response at Week 26.
    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 No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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
    Date of the final clinical database lock
    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 months7
    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 months7
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 288
    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 Decision2007-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-16
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