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    Summary
    EudraCT Number:2009-011719-19
    Sponsor's Protocol Code Number:AS001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-011719-19
    A.3Full title of the trial
    PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH
    ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberAS001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorSchwarz Biosciences, GmbH
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    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 INNCERTOLIZUMAB PEGOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.13.1Other medicinal product typePEGylated humanized antibody Fab` fragment
    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
    AXIAL SPONDYLOARTHRITIS (AXIAL SPA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002557
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10051265
    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 the study is to demonstrate the efficacy of CZP administered sc at the doses of CZP
    200mg every 2 weeks and CZP400mg every 4 weeks after a loading dose of CZP 400mg at Weeks 0, 2, and 4 on
    the signs and symptoms of active axial SpA.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the effects on safety and tolerability and
    to demonstrate the effects of CZP on:
    - Health outcomes
    - Partial remission
    - Spinal mobility
    - Structural damage and inflammation in the subpopulation of subjects with MRI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be at least 18 years old at the Screening Visit.
    2. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent is signed and dated by the subject.
    3. The subject is considered reliable, willing and capable of adhering to the protocol (eg,able to understand and complete diaries), visit schedule, and medication intake according
    to the judgment of the Investigator.
    4. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of
    childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use
    adequate contraception during the study and for at least 10 weeks (or longer if required by local regulations) after the last dose of study treatment. Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 10 weeks (or longer if required by local regulations) after the subject receives
    their last dose of study treatment.
    5. Subjects must have a documented diagnosis of adult-onset axial SpA of at least 3 months�duration as defined by the specified ASAS criteria .
    6. Subjects must have active disease as defined by
    - BASDAI score &#8805; 4
    - Back pain &#8805; 4 on a 0 to 10 NRS (from BASDAI item 2)
    7. Subjects must have been intolerant to or had an inadequate response to at least 1 NSAID.
    Inadequate response to an NSAID is defined as lack of response to at least 30 days of continuous NSAID therapy at the highest tolerated dose of the administered NSAID or
    the lack of response to treatment with at least 2 NSAIDs at the maximum tolerated dose for 2 weeks each.
    E.4Principal exclusion criteria
    Subject:
    1. has previously participated in this study or has previously received CZP treatment in or outside of another
    clinical study.
    2. has participated in another study of a medication or a medical device under investigation within the last 3
    months or is currently participating in another study of a medication or medical device under investigation.
    3. has history of chronic alcohol abuse or drug abuse within the last year.
    4. has any medical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would
    compromise the subject�s ability to participate in this study.
    5. has a known hypersensitivity to any components of CZP, placebo or with a history of an adverse reaction to
    polyethylene glycol (PEG).
    6. must not have total spinal ankylosis (�bamboo spine�), a diagnosis of any other inflammatory arthritis eg, RA,systemic lupus erythematosus, sarcoidosis, or a known diagnosis of fibromyalgia.
    7. must not have a secondary, noninflammatory condition that in the Investigator�s opinion is symptomatic
    enough to interfere with evaluation of the effect of study drug on the subject�s primary diagnosis of axial SpA.
    8. must not have used the medications in the manner as detailed by the exclusion criteria in the protocol.
    9. must not have received any nonbiological therapy for axial SpA not listed in section "Prior medications exclusion" of the protocol within or outside a clinical study in the 3 months or within 5 half lives prior to the Baseline Visit (whichever is longer).
    10. must not have received any experimental biological agents other than those permitted in section "Prior
    medications exclusion" of the protocol.
    11. must not have received previous treatment with a PEGylated compound that resulted in a severe
    hypersensitivity reaction or an anaphylactic reaction.
    12. may not have been exposed to more than 1 TNF antagonist prior to the Baseline Visit and may not be a
    primary failure to any TNF antagonist therapy (as defined in the protocol).
    13. may not have been exposed to more than 2 previous biological agents for axial SpA.
    14. Female who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months
    following the last dose of the investigational product.
    15. with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics or antivirals during the preceding year), recent serious or life�threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster), hospitalization for any infection in the last 6 months or any current sign or symptom that may indicate an infection.
    16. with known TB disease, high risk of acquiring TB infection, or latent TB infection, as defined in the protocol.
    17. with concurrent acute or chronic viral hepatitis B or C or with known human immunodeficiency virus (HIV)
    infection.
    18. with known history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides,Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus.
    19. must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
    20. receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline.
    21. with a high risk of infection in the Investigator�s opinion.
    22. with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms
    suggestive of lymphoproliferative disease.
    23. with concurrent malignancy or a history of malignancy (subjects with less than 3 excised basal cell
    carcinomas or with cervical carcinoma in situ successfully surgically treated more than 5 years prior to Screening may be included).
    (from 24 to 29 see protocol)
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable: ASAS20 response at Week 12.
    Pharmacokinetic and pharmacodynamic variables:
    - Certolizumab pegol plasma concentrations at periods defined in the protocol.
    - Anti-CZP antibodies at periods defined in the protocol.
    - Dickkopf-related protein 1 (DKK1) and sclerostin levels may be analyzed for exploratory biomarker research
    using selected samples collected for measurement of CZP plasma concentration
    Safety variables:
    - adverse events,
    - serious adverse events,
    - vital signs,
    - physical examination findings,
    - signs and symptoms of latent or active tuberculosis,
    - measurements of laboratory parameters (hematology, biochemistry and urinalysis),
    - pregnancy testing
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    dalla week 24 alla 48: no placebo, dose in cieco per paziente/medico e dalla week 48: in aperto
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=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 250
    F.4.2.2In the whole clinical trial 400
    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)
    fare riferimento alle seguenti sezioni del Protocollo: -5.1 ``Study description`` -8.7`` Completion visit/Early withdrawal -8.8`` Safety follow-up visit``
    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 Decision2010-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-23
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