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    The EU Clinical Trials Register currently displays   36603   clinical trials with a EudraCT protocol, of which   6045   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
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    EudraCT Number:2007-000082-38
    Sponsor's Protocol Code Number:HUM05-019
    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:2007-03-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2007-000082-38
    A.3Full title of the trial
    The OPERA Study.

    Optimized treatment algorithm in early rheumatoid arthritis:
    Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis.
    A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development.
    A.3.2Name or abbreviated title of the trial where available
    The OPERA Study
    A.4.1Sponsor's protocol code numberHUM05-019
    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 SponsorAarhus University Hospital, Denmark
    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 support
    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. name Humira (adalimumab)
    D. 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® (adalimumab)
    D.3.2Product code 2593
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdalimumab
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    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
    In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Inflammatory control as assessed primarily by number of patients who achieve a DAS28 < 3.2 after 12 and 24 months (Zero hypothesis: in early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is not better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2.
    E.2.2Secondary objectives of the trial
    In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab does not result in an improved outcome compared to methotrexate and intra-articular glucocorticoid alone as assessed by the development of joint erosions and cartilage), and

    In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab does not cause more adverse events including serious adverse events resulting in therapeutic consequences compared to methotrexate and intra-articular glucocorticoid alone).
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pathogenesis of IL-20 in early rheumatoid arthritis

    Pathogenesis of IL-22BP in early rheumatoid arthritis

    Chemokine receptors as markers of disease activity, radiological progression and treatment response in early rheumatoid arthritis.

    Endothelial progenitor cells (EPC) og cardiovascular changes in early rheumatoid arthritis.

    Antibody micro arrays for determination of defense collagens and complement proteins in patients with early reheumatoid arthritis before and after conventional DMARD and/or anti-TNF-alpha inhibitor treatment: analysis and correlation to disease activity, progression of joint destruction, and treatment response

    Adiponectin as a marker for disease activity, radiological progression and treatment response in early rheumatoid arthritis.

    Inflammatory- and bone biomarkers as well as gene and micro RNA array patterns in early rheumatoid arthritis.

    Validation of cartilage and bone markers in early rheumatoid arthritis.

    New markers for antigen presentation and autoimmunity
    Study 1: The role of sortilin for MHC-II-mediated antigen presentation
    Study 2: Association between human MHC2TA promoter III polymorphism, MHC-II
    expression and rheumatoid arthritis
    Study 3: CD163 expression as prognostic marker for pharmacological response and
    disease progression in patients with early rheumatoid arthritis
    E.3Principal inclusion criteria
    Patients (³ 18 years) with rheumatoid arthritis according to the ACR classification criteria (1) who have been diagnosed £ 6 months.

    Moderate to severe rheumatoid arthritis defined as DAS28 (CRP-based) > 3.2.

    Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. (Non-fertile women are defined as postmenopausal for at least 1 year or surgical sterilisation (bilateral tubal ligation, bilateral oophorectomy or hystorectomy)). Fertile women included in the trial should use contraception during the entire trial period (i.e. one of the following methods: Oral contraception, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). In addition, contraception should be used for a period of 150 days after any discontinuation of trial medicine.

    Ability and willingness to inject the sc. injections him/herself or to have an assistant give the injections.

    Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
    E.4Principal exclusion criteria
    Persons with latent TB (positive Mantoux test (>10 mm), positive inoculation of mycobacterium in tissue samples and/or chest X-ray indicating TB) or other risk factors for activation of untreated latent TB

    Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion

    Positive serology for Hepatitis B or C indicating active infection.

    Medical history with positive HIV status (Check of HIV test upon suspicion).

    Medical history with histoplasmosis or listeriosis.

    Previous cancer or lymph proliferative disease except from completely well treated squamous cell carcinoma, basal cell skin carcinoma or cervix dysplasia.

    Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, disturbed gait, facial paralysis, apraxia).

    Severe renal insufficiency (creatinine clearance < 35 ml/min - nomogram).

    Affected liver function: Liver enzymes > 2 x above normal limit value.

    Clinical significant drug or alcohol abuse during the past year and/or current daily alcohol consumption.

    Diabetes, unstable ischemic heart disease, heart insufficiency (NYHA III-IV), active chronic inflammatory intestinal disease, recent cerebral apoplexia (within 3 months), chronic leg ulcer or any other condition (e.g. catheter a demeure) imposing an increased risk on to the subject, if he/she participates in the protocol, as judged by investigator.

    Anticoagulant therapy.

    Pregnancy or breast-feeding.

    Other inflammatory rheumatic diseases.

    Aggressive parvovirus B19 infection.

    Previous treatment with one or more DMARDs.

    Glucocorticosteroid treatment within the last 4 weeks (except nasal and inhalation steroids).

    Contraindications for trial medicine.
    E.5 End points
    E.5.1Primary end point(s)
    Assuming that 90% of patients treated with adalimumab and 70% of patients treated with placebo achieve the primary clinical endpoint (DAS < 3.2) after 12 and 24 months.

    Assuming that 90% of patients treated with adalimumab and 70% of patients treated with placebo achieve the primary radiographic endpoint (no radiographic progression) after 12 and 24 months.
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    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. 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 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 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.8.3 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 concerned18
    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
    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
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-03-26. Yes
    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. of subjects incapable of giving consent
    Women of childbearing potential, women of childbearing potential using contraception
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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 Decision2007-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-30
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