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    Summary
    EudraCT Number:2009-013758-33
    Sponsor's Protocol Code Number:RA0028
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-013758-33
    A.3Full title of the trial
    MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS
    A.4.1Sponsor's protocol code numberRA0028
    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 Pharma S.A.
    B.1.3.4CountryBelgium
    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 Pharma S.A
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Pharma
    B.5.2Functional name of contact pointCT Registries & Results Disclosure
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 48 1515
    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 SA
    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 (CZP)
    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.3.9.2Current sponsor codeCDP870
    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 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 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
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 identify the first time point the OMERACT RAMRIS score for the activity of synovitis is statistically significantly reduced compared to Baseline in response to CZP therapy.
    E.2.2Secondary objectives of the trial
    • To identify the efficacy of CZP on synovitis in dynamic MRI parameters of IRE, ME, and Nvox with Plateau and Washout pattern
    • Correlation of reduction of synovitis as measured by MRI at Week 16 with:
    ◦ EULAR response
    ◦ ACR20, ACR50, and ACR70 response
    ◦ DAS28 response
    ◦ X-ray changes in bone mineral density
    • Change from Baseline for the OMERACT RAMRIS synovitis scores at Week 1 and Week 2 will be analyzed and compared between treatment groups (CZP versus PBO).
    • Assessment of clinical response during double-blind and OLE periods
    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 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. Subjects must be 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 10 weeks after their last dose of CZP (or longer if required by local regulations).
    5. Subjects must have a diagnosis of adult-onset RA of at least 3 months duration but not longer than 15 years as defined by the 1987 American College of Rheumatology classification criteria.
    6. Subjects must be rheumatoid factor positive and/or anti-CCP positive.
    7. Inclusion Criterion 7 was deleted in Protocol Amendment 2.
    8. Subjects must have active RA disease as defined by the protocol.
    9. Subjects must be on DMARD therapy for at least 12 weeks and the dose and route of administration should be stable for at least 8 weeks prior to Baseline. The eligibility for TNF therapy will be based upon appropriate medical judgment and as defined in local regulations and guidance and accoring to medical practice.
    10. Subjects must be able and willing to comply with the requirements of the study protocol.
    11. Subjects must have a normal renal function with creatinine within normal limits at screening.
    12. The normal renal function being defined as eGFR (MDRD) > 60 ml/min/1.732 body surface
    area at Screening and calculated according to the formula eGFR = 175 x (serum creatinine)^- 1.154 x (age)^0.203 x (0.742 if female) x (1.212 if African American).
    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 a history of chronic alcohol or drug abuse within the last 6 months).
    3. 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.
    4. Subject has a known hypersensitivity to any components of the IMP as stated in the protocol.
    5. Subjects must not have a secondary, noninflammatory type of musculoskeletal 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 RA.
    6. Subjects must not have a diagnosis of any other inflammatory arthritis.
    7. Subjects must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
    8. Subjects must not have received any of the prohibited medication as detailed in the protocol.
    9. Subjects must not have received any experimental nonbiological therapy in the 3 months or within 5 half-lives prior to Baseline (whichever is longer).
    10. Subjects must not have received any experimental biological agent in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer).
    11. Subjects must not have received infliximab or abatacept therapy in the 3 months prior to Baseline.
    12. Subjects must not have received adalimumab, golimumab or etanercept therapy in the 2 months prior to Baseline.
    13. Subjects must not have received treatment with rituximab and tocilizumab.
    14. Subjects must not have received more than 1 biological agent.
    15. Subjects must not have been primary failures (ie, never achieved meaningful improvement) to prior anti-TNF therapy.
    16. Subjects must not have contraindications for MRI and contrast agent.
    17. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the trial or within 12 weeks following last dose of study drug.
    18. Subjects with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.
    19. Known TB disease, high risk of acquiring TB infection, or latent TB infection (as defined in the protocol).
    20. Subjects at a high risk of infection (as stated in the protocol).
    21. Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
    22. Subjects with concurrent acute or chronic viral hepatitis B or C.
    23. Subjects with known human immunodeficiency virus (HIV) infection.
    24. Subjects receiving live or attenuated vaccination within 8 weeks prior to Baseline (as stated in the protocol).
    25. Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to Screening).
    26. Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease.
    27. Subjects with class III or IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria.
    28. Subjects with a history of, or suspected, demyelinating disease of the central nervous system.
    29. Subjects with any other condition which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable:
    Change from Baseline (Day 0) in OMERACT RAMRIS synovitis score measured with MRI (gadolinium-containing contrast agent) of 1 hand and wrist at Weeks 1, 2, 4, 8, and 16.

    Safety variables:
    - Adverse events and serious adverse events
    - Physical examination (including signs and symptoms of latent or active tuberculosis) and vital signs
    - Clinical laboratory values (hematology, serum biochemistry, and urinalysis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 week double-blind, placebo controlled (during the initial 2 weeks) randomized period, followed by a 24 week open-label extension.
    E.5.2Secondary end point(s)
    • Dynamic MRI parameters of IRE, ME, and Nvox at Day 0 and Weeks 1, 2, 4, 8, and 16 during the double-blind period.
    • EULAR response at Weeks 2, 4, 6, 8, 10, 12, 14, and 16 during the double-blind period, then every 8 weeks during the OLE period, and at the Completion/Withdrawal Visit.
    • ACR20, ACR50, and ACR70 at Weeks 2, 4, 6, 8, 10, 12, 14, and 16 during the double blind period, then every 8 weeks during the OLE period, and at the Completion/Withdrawal Visit.
    • Change from Baseline in DAS28-CRP at Weeks 2, 4, 6, 8, 10, 12, 14, and 16 during the double-blind period, then every 8 weeks during the OLE period, and at the Completion/Withdrawal Visit.
    • DAS28-CRP remission status at Weeks 2, 4, 6, 8, 10, 12, 14, and 16 during the double blind period, then every 8 weeks during the OLE period, and at the Completion/Withdrawal Visit.
    • Change from Baseline in bone mineral density (g/cm2) as measured by DXR at Week 16.
    • Change from Baseline in ACR components: tender joints and swollen joints, and Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16 during the double-blind period, then every 8 weeks during the OLE period, and at the Completion/Withdrawal Visit.
    • Ratio to Baseline for C-reactive protein (CRP) at Weeks 2, 4, 6, 8, 10, 12, 14, and 16 during the double-blind period, then every 8 weeks during the OLE period, and at the Completion/Withdrawal Visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 week double-blind, placebo controlled (during the initial 2 weeks) randomized period, followed by a 24 week open-label extension.
    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 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 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
    study is placebo-controlled during the initial 2 weeks and there is a 24-week open-label extension
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 Information not present in EudraCT
    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
    The end of the study is defined as the date of the last Safety Follow-Up phone contact of the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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)
    Please refer to sections 8.14 and 8.15 in protocol
    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 Decision2010-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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