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    Summary
    EudraCT Number:2008-006227-31
    Sponsor's Protocol Code Number:0881X1-4503
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-006227-31
    A.3Full title of the trial
    Inflammatory Topoproteome of Psoriasis under Etanercept Treatment
    A.3.2Name or abbreviated title of the trial where available
    IDEA Trial
    A.4.1Sponsor's protocol code number0881X1-4503
    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 SponsorMedical Faculty, Otto-von-Guericke-University Magdeburg
    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 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 Enbrel 50 mg Fertigspritze (= ready for use syringe for s.c. injection)
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europe Limited
    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.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant protein
    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
    Patients with a severe psoriasis will be treated with Enbrel (Etanercept) 2 x 50 mg s.c. per week over 12 weeks (n = 6 patients). The treatment follows rigorously the approved label of the drug. The design of the study deviates from the approved label status in the only regard that within the course of the treatment per patient i) 5 skin biopsies with a horizontal diameter of 6 mm are taken in local anesthesia and ii) 4 peripheral venous blood drawings of 10 ml, each, are performed.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analysis of the inflammatory topoproteome of i) skin tissue and ii) peripheral blood mononuclear cells in psoriasis under etanercept treatment.
    E.2.2Secondary objectives of the trial
    i) Analysis of change of Psoriasis Area and Severity Index (PASI), Physician´s Global Assessment (PGA), itch-score and Dermatologic Life Quality Index (DLQI) for evaluation of clinical efficacy, as well as treatment-response and treatment-non-response.
    ii) Evaluation of treatment safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    According to approved label status of Enbrel:

    Adult patients with moderate to severe plaque psoriasis, who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including cyclosporin, methotrexate and PUVA.


    According to study protocol:

    The patient is able to understand the study and capable to give informed consent.

    Written informed consent.

    Age of more than 18 years.

    Psoriasis Area and Severity Index (PASI) of more than 10 or involvement of body surface by psoriasis for more than 10% or Dermatologic Life Quality Index (DLQI, according to Finlay and Kahn) of more than 10.

    Exclusion of an active or latent tuberculosis by negative tuberculosis-skin/-blood-test and chest x-ray.

    Consideration of the following wash-out-intervals before the start of study medication: i) 2 weeks for antipsoriatic topical drugs (vitamin D and analogues, tazarotene, corticosteroids, tar), ii) 4 weeks for conventional antipsoriatic systemic drugs (methotrexate, acitretin, fumarates and ciclosporin), iii) 4 weeks for UV-treatment, iv) 3 months for efalizumab, adalimumab, infliximab, and golilumab, v) 6 months for ustekinumab, and vi) 6 months for any investigational compound / drug.

    In case of treatment with a beta-blocker, ACE-inhibitor, anti-malaria drug (resochin), interferon or lithium: stable medication with these agents for at least 4 weeks before the start of the study medication.

    No foreseeable necessity for vaccinations during 4 weeks before the start of the study medication, during 16 weeks of study medication and during 8 weeks afterwards.

    Willingness to keep natural / sun light exposure adequately constant und to avoid the use of artificial UV exposition (solarium).

    Use of anticonception in female and male study participants under study medication.
    E.4Principal exclusion criteria
    According to approved label status of Enbrel:

    Hypersensitivity against the active compound (i.e. etanercept) or any other compound of Enbrel or to latex of the lid of the Enbrel syringe.

    Sepsis or risk of sepsis.

    A treatment with Enbrel must not be initiated in patients with active infections, including chronic or localised infections.


    According to study protocol:

    Severe/relevant infections including infections by tuberculosis bacteria, HIV, hepatitis B or C virus.

    Cronic or relapsing infections in the history.

    Diseases favouring infections, e.g. severe or un-controlled diabetes mellitus.

    Intake of immunosuppressive agents / drugs.

    Treatment with anankinra (= Kineret) or abatacept (= Orencia) or sulfasalazin.

    Indication for a demyelinating disease (e.g. multiple sclerosis) in the patient´s history or in the history of a family member.

    Heart insufficiency (NYHA III/IV).

    Malignancies of recent relevance (incl. solid tumors, malignant hematopoetic diseases, lymphoproliferative diseases, non-melanocytic skin cancer).

    Blood dyscrasia (incl. severe anemia, leukopenia, thrombocytopenia, pancytopenia).

    Moderate or severe alcohol hepatitis.

    Treatment resistance to Enbrel.

    Intolerance to biologics.

    Autoimmune diseases coinciding with the formation of antinuclear antibodies.

    Precedent or current medication with azathioprine or 6-mercaptopurine.

    History of a Felty syndrome or of a splenomegaly in combination with leukocytopenia.

    Pregnancy.

    Breast feeding.

    Up-coming need for vaccination with live vaccine.

    Absolute criteria for premature discontinuation are:

    - Occurence of pregnancy.

    - Clinically significant worsening of disease - defined as an increase of PASI of > 50% as compared to the begin of study medication.

    - Grade 3 systemic toxicity.

    - Grade 4 adverse event or a serious adverse event thought to be related to study medication.

    - Serious infection (grade 3) incl. sepsis syndrome with hypotension.

    - Withdrawal of consent.

    - Significant exposure to varicella-virus.

    - Need for vaccination with live vaccine.

    The treatment may be discontinued under the following conditions:

    - Lack of subject compliance.

    - Significant protocol deviation.

    - Upon decision of the investigator due to serious other reasons.



    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the antipsoriatic treatment of the study participants with enbrel 2 x 50 mg s.c / week for 12 weeks. At that time point PASI-50-response and PASI-75-response will be recorded.
    The primary study parameters are the analysis of the inflammatory topoproteome in skin tissue and mononuclear cells of peripheral blood, respectively.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Proteomic and Topoproteomic
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    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 years1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state6
    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 Decision2009-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
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