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    Summary
    EudraCT Number:2013-000337-13
    Sponsor's Protocol Code Number:PreCePra
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-11
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2013-000337-13
    A.3Full title of the trial
    Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled study
    Prediction of response to Certolizumab-Pegol in RA (PreCePRA)
    Previsão da resposta ao tratamento com Certolizumab Pegol através de Ressonância Magnética (RM) funcional do cérebro. Um estudo randomizado, controlado, multicêntrico, com dupla ocultação.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled study
    Prediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)
    Previsão da resposta ao tratamento com Certolizumab Pegol através de Ressonância Magnética (RM) do cérebro. Um estudo randomizado, controlado, multicêntrico, com dupla ocultação.
    Previsão da resposta ao tratamento com Certolizumab-Pegol na Artrite Reumatóide (PreCePRA)
    A.3.2Name or abbreviated title of the trial where available
    PreCePRA
    PreCePRA
    A.4.1Sponsor's protocol code numberPreCePra
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01864265
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointClinical Trial Unit, Med. 3
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number+4991318543014
    B.5.5Fax number+4991318535784
    B.5.6E-mailjuergen.rech@uk-erlangen.de
    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 nameCimzia
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 codeUCB SA
    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 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 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 and suspension for suspension 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
    Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
    E.1.1.1Medical condition in easily understood language
    RA patients DMARD -IR
    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 10040107
    E.1.2Term Seropositive rheumatoid arthritis
    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
    The primary parameter of interest is the proportion of patients who reach low disease activity according to the DAS28 (DAS28 < 3.2) during the first 12 weeks of study participation according their baseline CNS activity measured by functional MRI.
    E.2.2Secondary objectives of the trial
    To compare clinical responses to Certolizumab-Pegol in RA patients with high and low CNS activity in the functional MRI to placebo responses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects must have a diagnosis of Rheumatoid Arthritis (RA), fulfilling the new ACR/EULAR classification criteria 2010 with disease duration for at least 24 weeks.
    • Active RA with a DAS28 of >3.2
    • ≥3 swollen and/or tender joints of the hands
    • Subjects must be DMARD-IR (inadequate responder)
    • Must understand and voluntarily sign an informed consent form including written consent for data protection
    • Must be able to adhere to the study visit schedule and other protocol requirements
    • Must be aged ≥ 18 years at time of consent
    • Glucocorticoids treatment up to 10 mg prednisolon per day will be allowed at study entry
    • At screening-visit patients should have been treated without alterations of DMARD therapy (for at least three months) (i.e. Methotrexate) (with or without concomitant use of steroids).
    • Must be RF and/or ACPA positive
    • ≥ 3 swollen and/or tender joints of the hands
    • At screening- visit patients should have been treated
    without alterations of therapy for at least three months
    with DMARDS (i.e. Methotrexate) with or without
    concomitant use of steroids).
    • Glucocorticoids treatment up to 10mg prednisolone per
    day will be allowed at study entry.
    E.4Principal exclusion criteria
    • Individuals not able to understand and follow study protocol and not able to voluntarily sign informed consent
    • Individuals not willing to follow study protocol and sign informed consent
    • Individuals treated with biological or investigational products before.
    • Individuals with claustrophobia, tattoos containing metal, magnetic endoprotheses, surgery on bone in between a time interval < 3 months, patients in any condition not allowing for MRI scan.
    • Current treatment with MMF or preparations still in development.
    • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
    • Any other autoimmune or inflammatory disease such as Psoriasis, SLE, PSS, MCTD, SpA, Behcet disease, vasculitis, autoimmune hepatitis or fibromyalgia
    • Participation in another phase 1-4 treatment study for RA
    • Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent
    • Pregnant or lactating female (Women with child bearing potential have to use a highly effective contraceptive measure (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs) and continue its use for the time of exposure to the drug as required). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable
    • Patients who possibly are dependent on the Principal Investigator or investigator
    • Patients with serious or chronic infections within the previous 3 months
    • Opportunistic infections within the 6 months before screening
    • Cancer within the 5 years before screening (with the exception of treated and cured squamous or basal cell carcinoma of the skin)
    • History of severe congestive heart failure
    • Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal (a.e.diverticulitis), endocrine, pulmonary, cardiac, neurologic or cerebral disease
    • Transplanted organ (with the exception of corneal transplantation done more than 3 months before screening)
    • Evidence of active tuberculosis
    • Evidence of chronic or active hepatitis B or C
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who reach low disease activity according to the DAS28 (DAS28 < 3.2) during the first 12 weeks of study participation according their screening CNS activity measured by functional MRI.
    Expected:
    • Group 1 (high voxel count treated with Certolizumab
    Pegol): 80%)
    • Group 2 (low voxel count treated with Certolizumab
    Pegol): 40%)
    • Group 3 (high or low voxel count treated with placebo):
    20%.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study
    E.5.2Secondary end point(s)
    • Proportion of subjects in each treatment group reaching remission (defined as DAS28 < 2.6) after 2 12 and 24 weeks
    • Proportion of subjects in each treatment group reaching low disease activity (defined as DAS 28 <3.2) after 24 weeks
    • Mean and median DAS28 after 2 12 and 24 weeks
    • Proportion of subjects in each treatment group reaching HAQ of zero after 12 and 24 weeks
    • Mean and median HAQ after 2 12 and 24 weeks
    • Mean and median SF-36 after 2 12 and 24 weeks
    • Proportion of subjects in each treatment group with normal functional MRI after screening, week 12 and 24 weeks
    • Proportion of subjects in each treatment group with normal functional MRI after screening, 12 and 24 weeks
    • Mean and median ultrasound synovitis score after 2, 12 and 24 weeks
    • Mean and median ultrasound synovitis score after 2, 12 and 24 weeks
    • Mean and median area of BOLD signal after screening, week 12 and 24 weeks
    • Type, frequency, severity and relationship of adverse events, serious adverse events or suspected unexpected serious adverse reactions to drugs used in this study
    • Number of subjects who prematurely discontinue Certolizumab-Pegol due to any adverse event
    • Mean and median changes of hormones after 2, 12 and 24 weeks compared to fMRI results
    • Mean and median changes of cytokines after 2, 12 and 24 weeks compared to fMRI results
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Germany
    Portugal
    Serbia
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Pregnancy, any event with elevated risk of interaction with immunosuppressive therapy such as myocardial infarction, pulmonary embolism, apoplexy; medical emergencies requiring immediate stationary treatment and / or surgery (severe traffic accident, ileus, etc.), and infectious diseases requiring anti-inflammatory therapy risking interaction with immunosuppressive therapy (compare composition of medical interactions).
    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 months0
    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 months0
    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.1.2.1Number of subjects for this age range: 156
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 156
    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. Patients will be treated to local guidelines..
    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 Decision2015-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-10
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