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    Summary
    EudraCT Number:2009-014394-41
    Sponsor's Protocol Code Number:WRAP
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-23
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-014394-41
    A.3Full title of the trial
    Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.
    Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)
    A.4.1Sponsor's protocol code numberWRAP
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHvidovre Hospital
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott laboratories A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameHumira
    D.3.2Product code Adalimummab
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeHumira
    D.3.9.3Other descriptive nameAdalimumab
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 to 40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Reumatoid artritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    At undersøge effekten af adalimumab på sygdomsmanifestationer i aksiale og perifere led og enteser hos patienter med RA vurderet med helkrops MRI
    E.2.2Secondary objectives of the trial
    At sammenligne håndled og 2.-5. MCP-led fremstillet med helkrops MRI med dedikeret MRI af håndled og MCP-led på den ekstremitet med størst sygdomsaktivitet på tidspunktet for inklusion.

    At sammenholde CT, helkrops MRI og dedikeret MRI af håndled og 2.-5. MCP-led med hensyn til forekomst og størrelse af knogleerosioner.

    At identificere mulige billeddiagnostiske og cirkulerende biomarkører (proteiner,
    gener, miRNA, metabolitter), der tillader forbedret vurdering af sygdomsaktivitet og sygdomsprogression

    At identificere mulige billeddiagnostiske og cirkulerende biomarkører (proteiner, gener, miRNA, metabolitter), der tillader forbedret prædiktion af terapeutisk respons

    At evaluere effekten af adalimumab på progression af kroniske forandringer i perifere led vurderet med konventionel røntgenundersøgelse, CT og MRI

    At undersøge led og enteser med ultralyd og sammenholde disse fund med klinisk undersøgelse, MR og biomarkører
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Alder >18 år og <85 år
    2. RA i henhold til American College of Rheumatologys 1987-kriterier
    3. Moderat eller svær aktiv RA defineret som DAS28 større end 3,2 (CRP-baseret)
    4. Klinisk indikation for TNF-α inhibitor behandling ved den behandlende læge
    5. Ingen tidligere TNF-α inhibitor behandling
    6. Ingen kontraindikationer for TNF-α inhibitor behandling (se afsnit 10.1.1)
    7. Ingen kontraindikationer for MRI (se bilag C).
    8. Serum/plasma kreatinin i normalområdet
    9. Sufficient anti-konception for fertile kvinder (se afsnit 7.2.1)
    10. I stand til at afgive informeret samtykke
    11. I stand til at følge protokollens undersøgelsesprogram
    E.4Principal exclusion criteria
    1. Andre DMARDs end MTX fra 4 uger før inklusion og i hele studieperiode
    2. Cyclophosphamid, klorambucil eller andre alkylerende stoffer fra 4 uger før inklusion og i hele studieperioden
    3. Intramuskulær eller intravenøs injektion af glucocorticoid fra 4 uger før inklusion og i hele studieperioden
    4. Graviditetsønske, graviditet eller amning
    5. Kontraindikationer mod behandling med TNF- inhibitor (se afsnit 10.1.1)
    6. Kontraindikationer mod MRI (se bilag C).
    7. Kendt nyligt medicin eller alkoholmisbrug
    8. Manglende skriftligt samtykke
    9. Manglende evne til at gennemføre undersøgelsesprogrammet af fysiske eller psykiske årsager
    E.5 End points
    E.5.1Primary end point(s)
    Primære billeddiagnostiske effektmål
    Tilstedeværelse af og ændringer i følgende billeddiagnostiske effektmål ved helkrops MRI vurderes:
    • Antallet af inflammerede perifere led.
    • Antallet af inflammerede perifere enteser.
    • Scoring af inflammatoriske forandringer i rygsøjlen og sacroiliacaled.

    Primære kliniske effektmål
    • Klinisk respons eller non-respons ved uge 16 i henhold til EULAR responskriterierne.
    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 No
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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 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
    Last subject last visit
    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 years0
    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.1.3Elderly (>=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 state40
    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)
    Provided 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 Decision2009-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-17
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