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    Summary
    EudraCT Number:2016-004300-65
    Sponsor's Protocol Code Number:AGO/2016/012
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-004300-65
    A.3Full title of the trial
    Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFα) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFα) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).
    A.3.2Name or abbreviated title of the trial where available
    SCINTRA TRIS
    A.4.1Sponsor's protocol code numberAGO/2016/012
    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 SponsorGhent University Hospital
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB Pharma SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGhent University Hospital
    B.5.2Functional name of contact pointBimetra Clinics
    B.5.3 Address:
    B.5.3.1Street AddressDe Pintelaan 185
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.6E-mailbimetra.clinics@uzgent.be
    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 name99mTc-S-HYNIC Certolizumab pegol
    D.3.4Pharmaceutical form Solution for injection
    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 INNCERTOLIZUMAB PEGOL
    D.3.9.1CAS number 428863-50-7
    D.3.9.4EV Substance CodeSUB25423
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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 No
    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
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    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 a treatment decision algorithm based upon ‘in vivo’ demonstration of TNFα by using a radiolabeled scintigraphic procedure with Technetium-labeled Cimzia®. To demonstrate that Cimzia® has a larger effect than alternative therapies (Orencia®/Roactemra®) in scintigraphy positive patients as compared to scintigraphy negative patients. Thus, we want to show that there is an interaction between the scintigraphic result and the treatment.
    E.2.2Secondary objectives of the trial
    A secondary objective is to show superiority of Cimzia® in the scintigraphy positive patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age between 18 and 70 years with presence of documented diagnosis (clinical evaluation, x-ray hands and feet ≤ 3 months before inclusion) of rheumatoid arthritis (RA) at least 3 months and no longer than 15 years defined according to the ACR/EULAR criteria 2010.
    • It should be a RA who has an inadequate response to at least 2 DMARDs of which one is methotrexate. Methotrexate should be started at least 3 months before baseline and the dosage and route of administration should be stable for at least 2 months before baseline. The minimal weekly doses allowed for methotrexate is 10 mg and the maximal dose is 25 mg.
    • Conform with the Belgian reimbursement criteria for anti-TNF therapy, the DAS28 should be > 3.7.
    • Patients should have failed one, but maximum two anti-TNFα treatments other than Cimzia®.
    • Active disease according to the rheumatologist with DAS28 score ≥3.7 and at least 1 swollen joint clinically on a 66-swollen joint count.
    E.4Principal exclusion criteria
    • The patients may not have received any experimental biological and/or non-biological therapy in the last 3 months or 5 times the half-life of the therapy before baseline.
    • The patients may not have received a treatment with certolizumab pegol and/or abatacept and/or tocilizumab and/or rituximab.
    • Known hypersensitivity to certolizumab pegol ,abatacept or tocilizumab or one of its excipients.
    • Current or recent history of severe progressive uncontrolled renal, hepatic, hematological, gastro-intestinal, endocrinal, pulmonal, cardial, neurological or cerebral disorders.
    • Severe or life-threatening infection in the last 6 months; signs and symptoms of a current or recent infection.
    • Actieve tuberculosis.
    • Latent tuberculosis, with the exception of patient who are adequately treated according to the local regulations. Absence of latent tuberculosis is defined as a negative tuberculine skintest (Mantoux PPD test) and a recent (< 6 months) x-ray of thorax which shown no suggestive injuries for TB.
    • Known or current viral hepatitis B or hepatitis C infection. Known HIV infection.
    • Presence of malignity or history of a maligne pathology.
    • History of lymphoproliferatic disorder or signs or symptoms suggestive for such a disorder.
    • Moderate to severe cardiac failure (NYHA-class III/IV).
    • Women of childbearing potential and who are not taking adequate contraception (such as oral/parenteral/implantable hormonal therapy, intra-uterine device, or barrier and spermicide method). Patient should agree to use adequate contraception during the study and until 12 weeks after the last administration of certolizumab pegol, abatacept or tocilizumab.
    E.5 End points
    E.5.1Primary end point(s)
    Demonstration of significant ‘in vivo’ TNFα expression would predict a good response to the ‘TNFα Class Switch’-option, whereas absence of demonstrable TNFα would result in a better response to a biological with another mode of action.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    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 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
    Evaluation of a treatment decision algorithm based upon ‘in vivo’ demonstration of TNFα by using a radiolabeled scintigraphic procedure with Technetium-labeled Cimzia®.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 concerned7
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    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
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state120
    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 Decision2017-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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