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    Summary
    EudraCT Number:2013-000337-13
    Sponsor's Protocol Code Number:PreCePra
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-12
    Trial 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 ConcernedGermany - PEI
    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)
    Vorhersage des Ansprechens von Certolizumab Pegol mittels funktionellem MRT des Gehirns. Eine multicenter, randomisierte doppel-blind Studie.
    Vorhersage des Ansprechens von Certolizumab-Pegol in der RA (PreCePra)
    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)
    Vorhersage des Ansprechens von Certolizumab Pegol mittels Bildgebung des Gehirns. Eine multicenter, randomisierte doppel-blind Studie.
    Vorhersage des Ansprechens von Certolizumab-Pegol in der Rheumatoiden Arthritis (PreCePra)
    A.3.2Name or abbreviated title of the trial where available
    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
    Patienten mit einer aktiver Rheumatoiden Arthritis (DAS28 > 3.2) trotz Therapie mit DMARD`s
    E.1.1.1Medical condition in easily understood language
    RA patients DMARD -IR
    RA Patienten DMARD-Versager
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    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.
    Das Hauptparameter ist, festzustellen welcher Anteil an Patienten eine low-disease Aktivität (DAS28 <3.2) innerhalb von 12 Wochen erreicht in Bezug auf ihre ZNS Aktivität gemessen mittels funktionellem MRT
    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
    Vergleich des klinischen Ansprechens auf Certolizumab Pegol bei Patienten mit RA mit hoher oder niedriger ZNS Aktivität im funktionellen MRT zur Plazebo Antwort.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Understands and voluntarily signs an informed consent
    form
    • Male or female, aged ≥ 18 years at time of consent
    • Must be able to adhere to the study visit schedule and
    other protocol requirements
    • Must satisfy the 2010 ACR/EULAR classification criteria
    for rheumatoid arthritis plus a disease duration of at
    least 6 months
    • Must have active RA with a DAS28 ≥3.2
    • ≥ 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.
    - Patienten müssen die Patienten Aufklärung verstehen und bereit
    sein sie zu unterschreiben.
    - Frauen oder Männer > 18 Jahre
    - müssen fähig sein die Patientenvisiten sowie die Anforderungen
    des Protkolls einzuhalten und zu befolgen
    - Müssen die ACR/EULAR Kriterien von 2010 für die RA erfüllen
    und mindestens 6 Monate die Erkrankung haben
    - Es muss eine Aktive RA mit einem DAS28 > 3.2 sein
    - ≥ 3 geschwollene und/oder 3 schmerzhafte Gelenke haben.
    - Zum Screening müssen die Patienten mindestens seit 3 Monate
    auf einer stabilen DMARD Therapie (z.B. MTX) sein mit oder ohne
    Kortikosteroiden.
    E.4Principal exclusion criteria
    • Individuals not able to understand and follow study
    protocol and not able to voluntarily sign informed consent
    • Individuals with claustrophobia, tattoos containing metal,
    magnetic endoprostheses, surgery on bone in between a
    time interval < 3 months.
    • Patients treated before with any biological or small
    molecule or medication under investigation for the
    treatment of RA.
    • 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
    - Patienten die nicht fähig sind das Studienprotokoll zu verstehen und
    nicht gewillt sind die Patienteininformation zu unterschreiben.
    - Patienten mit Klaustrophobie, Tattoo`s die Metall enthalten,
    magnetische Endoprothesen, Operation innerhalb eines
    Zeitintervalls von 3 Monaten
    - Patienten die zuvor mit einem Biologika, "small-molecule" oder
    mit einem aktuellem Studienmedikament für die Behandlung der
    RA therapiert werden.
    - Patienten mit schweren oder chronischen Infekten innerhalb der
    letzten 3 Monate
    - Opportunistische Infektionen innerhalb der letzen 6 Monate
    - Bösartige Erkrankungen innerhalb der letzen 5 Jahre vor
    Screening (mit Ausnahme von behandelten oder geheilten
    squamösen oder Basalzell Karzinomen).
    - vorbestehendes schwere Herzinsuffizienz
    - aktuell Zeichen oder Symptome einer schweren, fortschreitenden
    oder unkontrollierten Erkankung der Niere, Leber, Knochenmark,
    Gastrointestinal (z.B. Divertikulitis), Endokrin, Pulmonal, Herz
    neurologisch oder ZNS Erkrankung
    - Organtransplantationen
    - Aktive Tuberkulose
    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%.)
    Anzahl der Patienten in jeder Behandlungsgruppe die eine Remission oder low disease Aktivität (DAS < 3.2) nach 12 Wochen erreicht haben in Abhängigkeit der ZNS Aktivität im Screening fMRI

    Erwartet:
    Gruppe 1 (hohe Voxel Aktivität die mit Certolizumab
    Pegol behandelt werden: 80%)
    Gruppe 2 (niedrige Voxel Aktivität die mit Certolizumab behandelt
    werden: 40%)
    Gruppe 3 (hohe oder niedrige Voxel Aktivität die mit Placebo
    behandelt wurde):
    20%.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study
    Studienende
    E.5.2Secondary end point(s)
    • Proportion of subjects in each treatment group reaching remission (defined as DAS28 < 2.6) after 1, 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 1, 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 1, 12 and 24 weeks
    • Mean and median SF-36 after 1, 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 1, 12
    and 24 weeks
    • Mean and median ultrasound synovitis score after 1, 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, severe 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
    - Anzahl der Patienten in jeder Behandlungsgruppe die nach 1, 12
    und 24 Wochen eine Remission (DAs28 < 2.6 erreichen)
    - Anzahl der Patienten in jeder Behandlungsgruppe die nach 1, 12
    und 24 Wochen eine low disease Aktivität (DAS28 < 3.2)
    erreichen.
    - Median und Mittelwert vom DAS28 nach 1,12 und 24 Wochen
    - Anzahl der Patienten in jeder Behandlungsgruppe die nach 12
    und 24 Wochen einen HAQ von 0 erreichen
    - Median und Mittelwert vom HAQ nach 1,12 und 24 Wochen
    - Median und Mittelwert vom SF-36 nach 1,12 und 24 Wochen
    - Anzahl der Patienten in jeder Behandlungsgruppe die i,
    Screening, Woche 12 und Woche 24 ein normales fMRT haben.
    - Median und Mittelwert vom ultrasound synovitis score nach 1,12
    und 24 Wochen
    • Median und Mittelwert der Gehirnregion in der das Bold Signal
    gemessen wird nach 12 und 24 Wochen
    • Art, Häufigkeit, Schwere und Zusammenhang von AE`s, SAE`s
    oder SUSAR`s im Zusammenhang mit dem verwendeten
    Medikament
    • Anzahl der Patienten die zuvor die Studie beenden im
    Zusammenhang mit einem AE.





    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study
    Studienende
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Portugal
    Serbia
    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
    LVLS
    Letzte Visite des letzten Studienteilnehmers
    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 months0
    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 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    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..
    Keine Vorgaben, Patienten werden nach lokalen Richtlinien therapiert
    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 Decision2013-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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