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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-001894-41
    Sponsor's Protocol Code Number:AS0006
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-19
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-001894-41
    A.3Full title of the trial
    PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION.
    3. fázisú, multicentrikus, randomizált, kettős vak, placebo-kontrollált vizsgálat a certolizumab pegol hatásosságának és biztonságosságának meghatározására olyan aktív axiális spondylarthritisben (Axiális Spa) szenvedő alanyoknál, akiknél a röntgenvizsgálat nem igazol spondylitis ankylopoeticát (AS), de van objektív gyulladásra utaló jel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without X-ray evidence of AS
    A.4.1Sponsor's protocol code numberAS0006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02552212
    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 SponsorUCB 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 supportUCB BIOSCIENCES GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 Yes
    D.2.1.1.1Trade name CIMZIA certolizumab pegol 200 mg/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A.
    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 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 INNCERTOLIZUMAB PEGOL
    D.3.9.1CAS number 428863-50-7
    D.3.9.2Current sponsor codeCDP870
    D.3.9.4EV Substance CodeSUB25423
    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) 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
    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
    ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
    E.1.1.1Medical condition in easily understood language
    Multicenter study to evaluate efficacy and safety of Certolizumab Pegol in subjects with active inflammation in the spine with no damage on x-rays.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of CZP 200mg Q2W on the signs and symptoms of subjects with active axSpA without x-ray evidence of AS.
    E.2.2Secondary objectives of the trial
    To assess efficacy, safety, and tolerability and to
    demonstrate the effect of CZP on:
    - Health outcomes
    - Disease Activity
    - SI joint inflammation through MRI
    - Changes in concomitant and background medications
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or legal representative.
    2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
    3. Subject is at least 18 years old at the Screening visit.
    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 [for participating countries of the EU – 5 months in accordance with the Summary of Product Characteristics, SPC] 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 [for participating countries of the EU - 5 months in accordance with the SPC] longer if required by local regulations) after their last dose of study treatment.
    5. Subjects must have a documented diagnosis of adult-onset axSpA and met the ASAS criteria for axSpA (not including family history and good response to NSAIDs; see Appendix 18.1).
    6. Subjects must have had back pain for at least 12 months before Screening.
    7. Subjects must NOT have sacroiliitis defined by mNY criteria (see Appendix18.2) (bilateral ≥Grade 2; unilateral ≥Grade 3) on SI joint x-rays (based on central reading of x-rays, within the last 12 months from Baseline).
    8. Subjects must have active disease as defined by each of the following at Screening and Baseline:
    - BASDAI score ≥4
    - Spinal pain ≥4 on a 0 to 10 NRS (from BASDAI item 2)
    9. Subjects must have a combination of current evidence of sacroiliitis on the screening MRI as defined by ASAS/OMERACT scoring confirmed via central reading (MRI+) and CRP either >upper limit of normal (ULN) or ≤ULN (for CRP the ULN is defined as the ULN indicative for inflammatory disease) at Baseline (CRP+ or CRP-), or no evidence of sacroiliitis on the screening MRI (MRI-) and CRP >ULN (CRP+) as follows:
    - MRI+/CRP+
    - MRI+/CRP-
    - MRI-/CRP+
    10. Subjects must have had an inadequate response to, have a contraindication to, or have been intolerant to at least 2 NSAIDs. Inadequate response to an NSAID is defined as lack of response to at least 14 days of continuous NSAID therapy at the highest tolerated dose of the administered NSAID.
    E.4Principal exclusion criteria
    1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study.
    2. Subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 3 months (or 5 half-lives, whichever is greater) or is currently participating in another study of an IMP (or a medical device).
    3. Subject has history of chronic alcohol abuse or drug abuse within the last year.
    4. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
    5. Subject has a known hypersensitivity to any components of the IMP or comparative drugs as stated in this protocol.

    Axial SpA-disease-related exclusions
    6. Subjects must not have AS or any other inflammatory arthritis (eg, RA, systemic lupus erythematosus, or sarcoidosis).
    7. Subject must not have fibromyalgia.
    8. Subjects must not have a secondary, noninflammatory condition (eg, osteoarthritis) 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 axSpA.

    9. Prior medications exclusions Subjects must not have used the following medications in the manner as detailed by the exclusion criteria in the following table in the study protocol (see Table 7‒1).

    10- 13. Previous clinical studies and previous biological therapy exclusions- for details, please refer to page 52 of the study protocol.
    14-30. Medical History Exclusions- for details, please refer to pages 52-54 of the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    1. Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response at Week 52
    2. Axial SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 12 (this primary variable is applicable for countries where requested by regulatory authorities)
    3. Certolizumab pegol plasma concentration at Baseline
    4. Certolizumab pegol plasma concentration at Week 1
    5. Certolizumab pegol plasma concentration at Week 2
    6. Certolizumab pegol plasma concentration at Week 4
    7. Certolizumab pegol plasma concentration at Week 12
    8. Certolizumab pegol plasma concentration at Week 24
    9. Certolizumab pegol plasma concentration at Week 36
    10. Certolizumab pegol plasma concentration at Week 52
    11. Certolizumab pegol plasma concentration at Follow-Up Visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.; 10. Week 52
    2.; 7. Week 12
    3. Baseline (Week 0)
    4. Week 1
    5. Week 2
    6. Week 4
    8. Week 24
    9. Week 36
    11. Follow-Up Visit (8 weeks after the Week 52)
    E.5.2Secondary end point(s)
    1. Axial SpondyloArthritis International Society 40% response criteria (ASAS40) at Week 52
    2. Change from Baseline to Week 12 in the Bath ankylosing spondylitis functional index (BASFI)
    3. Change from Baseline to Week 52 in the Bath ankylosing spondylitis functional index (BASFI)
    4. Change from Baseline to Week 12 in the Bath ankylosing spondylitis disease activity index (BASDAI)
    5. Change from Baseline to Week 52 in the Bath ankylosing spondylitis disease activity index (BASDAI)
    6. Change from Baseline to Week 12 in sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) score
    7. Relevant changes to background medication from Baseline to Week 52
    8. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
    9. Change from Baseline in ASQoL at Week 1
    10. Change from Baseline in ASQoL at Week 2
    11. Change from Baseline in ASQoL at Week 4
    12. Change from Baseline in ASQoL at Week 12
    13. Change from Baseline in ASQoL at Week 24
    14. Change from Baseline in ASQoL at Week 36
    15. Change from Baseline in ASQoL at Week 48
    16. Change from Baseline in nocturnal spinal pain Numerical Rating Scale (NRS) at Week 52
    17. Occurence of anterior uveitis (AU) or new AU flares through Week 52
    18. Incidence of treatment-emergent adverse events (TEAEs) during the study
    19. Incidence of serious adverse events (SAEs) during the study
    20. Adverse events leading to withdrawal from investigational medicinal product (IMP) during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 52
    2.; 4.; 6.; 12.; From Baseline to Week 12
    3.; 5.; 7.; 8.; 16.; 17.; From Baseline to Week 52
    9. From Baseline to Week 1
    10. From Baseline to Week 2
    11. From Baseline to Week 4
    13. From Baseline to Week 24
    14. From Baseline to Week 36
    15. From Baseline to Week 48
    18.-20. From Baseline until Follow-Up (FU)/Safety Follow-Up Extension (SFE) (up to Week 60/156)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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.8.2.4Number 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Australia
    Bulgaria
    Canada
    Czech Republic
    Hungary
    Poland
    Russian Federation
    Taiwan
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 300
    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)
    A completion of the Week 52 Visit assessment, subjects on Double-Blind (DB) study treatment may receive Open-Label (OL) CZP treatment for an additional 2 years in an OL, Safety Follow-Up Extension (SFE) Period. Subjects who withdrew from DB study treatment and transitioned to OL CZP treatment are eligible to participate in the SFE Period after completing the Week 52 Visit assessments. Subjects on alternative treatments are not eligible to participate in the SFE Period.
    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 Decision2015-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-05
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