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    Summary
    EudraCT Number:2015-000339-34
    Sponsor's Protocol Code Number:AS0005
    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:2015-06-09
    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 number2015-000339-34
    A.3Full title of the trial
    MULTICENTER, OPEN-LABEL (PART A) FOLLOWED BY A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY (PART B) TO EVALUATE MAINTENANCE OF REMISSION IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) RECEIVING EITHER CERTOLIZUMAB PEGOL 200MG Q2W OR 200MG Q4W AS COMPARED TO PLACEBO
    AKTÍV AXIÁLIS SPONDYLOARTHRITISBEN (AXSPA) SZENVEDŐ VIZSGÁLATI BETEGEK KÖRÉBEN VÉGZETT TÖBBKÖZPONTÚ, NYÍLT (A. RÉSZ) VIZSGÁLAT, AMELYET EGY RANDOMIZÁLT, KETTŐS VAK, PÁRHUZAMOS CSOPORTOS, PLACEBO-KONTROLLOS VIZSGÁLAT (B. RÉSZ) KÖVET, A REMISSZIÓ FENNTARTÁSÁNAK ÉRTÉKELÉSÉRE, KÉTHETENTE VAGY NÉGYHETENTE ALKALMAZOTT 200 MG CERTOLIZUMAB PEGOL ESETÉN A PLACEBÓVAL TÖRTÉNŐ ÖSSZEHASONLÍTÁSBAN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TWO-PART MULTICENTER STUDY TO EVALUATE MAINTENANCE OF REMISSION OF AXSPA WITH CERTOLIZUMAB PEGOL COMPARED TO PLACEBO
    KÉTRÉSZES VIZSGÁLAT A REMISSZIÓ FENNTARTÁSÁNAK ÉRTÉKELÉSÉRE, A CERTOLIZUMAB PEGOL ÁGON A PLACEBÓVAL ÖSSZEHASONLÍTVA, AKTÍV AXIÁLIS SPONDYLOARTHRITISBEN (AXSPA) SZENVEDŐ BETEGEKNÉL
    A.3.2Name or abbreviated title of the trial where available
    C-Optimise
    A.4.1Sponsor's protocol code numberAS0005
    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 pointCT Registries & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+492173481515
    B.5.5Fax number+492173481572
    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
    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.3.1Product nameCertolizumab pegol
    D.3.2Product code CDP870
    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.3.9.4EV 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 in pre-filled syringe
    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)
    E.1.1.1Medical condition in easily understood language
    Spondyloarthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10071400
    E.1.2Term Axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 percentage of subjects who do not experience a flare on CZP 200mg Q2W (full dose) or 200mg Q4W (half-dose) as compared to placebo (CZP withdrawal) during Part B.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    -Evaluate the percentage of subjects achieving sustained remission at the end of Part A
    -For subjects randomized into Part B:
    1. Evaluate the time to flare and other measures of signs and symptoms
    2. Compare the percentage of subjects who do not experience a flare between CZP full-dose and half-dose
    3. Evaluate the efficacy of re-initiation of treatment with the CZP full-dose in subjects who experience a flare following a withdrawal or dose reduction of CZP
    -Assess safety and tolerability of CZP
    -Evaluate inflammatory changes over time as assessed by MRI
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subjects will be given the option to participate in a genetics, genomics, and proteomics sub-study. Subjects who decide to participate in the substudy must complete a separate Informed Consent Form. The purpose is to enable exploratory evaluation of biomarkers relative to drug treatment and inflammatory and immune response processes. Each subject's willingness to participate in the substudy will be independent from his/her consent to participate in the main study.
    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 by the parent(s) or legal representative.
    2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.
    3. Subject is at least 18 years old and not older than 45 years at the start of 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 (including 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 after the last dose of study treatment for at least 10 weeks (or - for participating countries of the European Union - 5 months in accordance with the Summary of Product Characteristics [SmPC]) or longer, if required by local
    regulations after the last dose of study treatment. Male subjects must agree to ensure that also their female partner(s) use adequate contraception during the study and for at least 10 weeks (or - for participating countries of the European Union - 5 months in accordance with the SmPC) 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 axSpA with at least 3 months' symptom duration as defined by the specified ASAS criteria (according to Appendix 18.1) and symptom duration of less than 5 years prior to the participation of this study.
    6. Subjects must have active disease at Screening as defined by the study protocol
    7. 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 has been assigned to treatment in a study of the medication under investigation in this study.
    2.Subject has participated in another study of an IMP (or a medical device) within the previous 3 months (or five 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 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.
    6. Subjects must not have fibromyalgia or total spinal ankylosis or any other inflammatory arthritis.
    7.Subjects must not have a secondary, noninflammatory condition that is symptomatic enough to interfere with evaluation of the effect of study medication on the subject's primary diagnosis of axSpA.
    8.Subjects must not have used medications as detailed in the protocol.
    9.Subjects must not have received any nonbiological therapy for axSpA not listed above within or outside a clinical study in the 3 months or within 5 half-lives prior to the Baseline Visit (whichever is longer).
    10.Subjects must not have received any experimental biological agents.
    11.Subjects must not have received previous treatment with a PEGylated compound that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.
    12.Subjects may not have been exposed to more than 1 TNF antagonist prior to the Baseline Visit and may not be a primary failure to TNF antagonist therapy.
    13.Female subjects who are breastfeeding or pregnant.
    14.Subjects with a history of chronic or recurrent infections recent serious or life-threatening infection within the 6 months prior to the Baseline Visit.
    15.Subjects with a history of herpes zoster infection within 6 months prior to the Baseline Visit.
    16. Subjects with known TB infection are excluded.
    17.Subjects with current acute or chronic viral hepatitis B or C or with HIV infection.
    18.Subjects with current or a history of active infection with histoplasma, coccidiodes, paracoccidioides, pneumocystis, nontuberculous mycobacteria, blastomyces, or aspergillus.
    19.Subjects must not have had a history of an infected joint prosthesis.20.Subjects receiving any live vaccination within the 8 weeks prior to Baseline.
    21.Subjects who have a high risk of infection.
    22.Subjects with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
    23.Current malignancy or a history of malignancy.
    24.Subjects with Class III or IV congestive heart failure as per the NYHA 1964 criteria.
    25.Subjects with a history of or suspected demyelinating disease of the central nervous system.
    26.Subjects who have had major surgery within 8 weeks prior to Screening or have planned surgery within 6 months of the Screening Visit.
    27.Subjects with current or history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, or neurological disease, as determined by the Investigator.
    28. Subjects with significant laboratory abnormalities as specified in the protocol.
    29.Subjects with any other condition that would make the subject unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of subjects in Part B who do not experience a
    flare.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the time to flare endpoint, the rules as described above for the primary endpoint will be applied to account for missing data when determining whether or not a subject experienced a flare. Subjects who discontinue the study without meeting the criteria for flare will be censored at the time of their last study visit. Subjects who complete the study without meeting the criteria for flare will be censored at their Week 96 visit.
    E.5.2Secondary end point(s)
    A) Secondary efficacy variables for subjects entering Part A
    -Percentage of subjects achieving sustained remission at Week 48
    -ASDAS disease activity (Ankylosing Spondylitis Disease Activity Score-Inactive Disease [ASDAS-ID], Ankylosing Spondylitis Disease Activity Score Moderate Disease [ASDAS-MD], Ankylosing Spondylitis Disease Activity Score-High Disease activity [ASDAS-HD], and Ankylosing Spondylitis Disease Activity Score-very High Disease activity [ASDAS-vHD]) and clinical improvement (Ankylosing Spondylitis Disease Activity Score-Clinically Important Improvement [ASDAS-CII], Ankylosing Spondylitis Disease Activity Score-Major Improvement [ASDAS-MI]) at Week 48
    B) Secondary efficacy variables for subjects entering Part B
    -Time to flare
    -ASDAS disease activity (ASDAS ID, ASDAS-MD, ASDAS-HD, and ASDAS-vHD) and clinical improvement (ASDAS-CII, ASDAS MI) at Week 96
    -ASAS20, ASAS40, ASAS5/6, and ASAS PR response at Week 96
    -Change from Baseline in ASDAS, BASDAI, BASFI, and BASMI at Week 96
    -BASDAI50 response at Week 96
    -Change from Baseline in sacroiliac SPARCC and spine ASspIMRI-a in the Berlin modification scores at Week 96
    C) Secondary efficacy variables for subjects who experience a flare in Part B (These will be evaluated at 12 weeks after escape and at Week 96, or a later timepoint, if applicable. The minimum full-dose treatment for the escapers is 12 weeks and could extend beyond the Week 96 visit.)
    -ASDAS disease activity (ASDAS-ID, ASDAS-MD, ASDAS-HD, and ASDAS-vHD) and clinical improvement (ASDAS-CII, ASDAS MI)
    -ASAS20, ASAS40, ASAS5/6, and ASAS PR response
    -Change from Baseline in ASDAS, BASDAI, BASFI, BASMI, and MRI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Selected continuous secondary efficacy variables will be analyzed using MMRM methods (see Section 14.3.2.2 for details). Missing data for binary response secondary efficacy variables will be handled using NRI. Secondary variables related to MRI will be analyzed based on the observed case data.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 Yes
    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 trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Belgium
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Netherlands
    Poland
    Romania
    Spain
    Turkey
    United Kingdom
    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
    LSLV
    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 months5
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days5
    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: 750
    F.1.3Elderly (>=65 years) No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 498
    F.4.2.2In the whole clinical trial 750
    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)
    standard care
    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 Decision2015-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-23
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