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    Summary
    EudraCT Number:2010-018279-99
    Sponsor's Protocol Code Number:HUM07-066
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-15
    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 - PEI
    A.2EudraCT number2010-018279-99
    A.3Full title of the trial
    Skin Topoproteome under Adalimumab (Humira®) Treatment
    in Patients with Moderate to Severe Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    Skin Topoproteome under Adalimumab Treatment of Psoriasis (TOTAL Study)
    A.4.1Sponsor's protocol code numberHUM07-066
    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 SponsorFaculty of Medicine, 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 Humira 40 mg injection solution in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd., Queenborough, Kent ME11 5 EL, United Kingdom
    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 typeAdalimumab (= Humira) is a recombinant human monoclonal antibody, i.e. a so-called biologic drug.
    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
    Disease under investigation: Adult patients of both genders with moderate to severe chronic plaque psoriasis who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. This is the exact label indication of Humira.
    Conditions: In this clinical trial Humira treatment will be performed completely "in-label" over 16 weeks (and facultatively over an additional 4 weeks during follow-up).
    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 topoproteome of skin tissue under standard treatment of psoriasis with Humira in an optimum of 12 patients by taking skin biopsies in local anesthesia before the beginning of the treatment (from involved and uninvolved psoriatic skin) and at weeks 1, 4 and 16 after the beginning of the treatment (from originally involved skin, representative areas). The skin tissue will be analyzed by multi epitope ligand cartography (=MELC).
    E.2.2Secondary objectives of the trial
    - Determination of anti-psoriatic treatment efficacy of Humira as well as detection of reponders and non-responders by determination of the following established standard parameters in the course of the above mentioned treatment: 1) psoriasis area and severity index (PASI), 2) physician´s global assessment (PGA), 3) pruritus score and 4) dermatology life quality index (DLQI).
    - Determination of treatment safety by the detection of possibly occuring adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    According to approved label status of Humira:
    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 cyclosporine, methotrexate or PUVA.

    No pre-treatment with Humira in the history.

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

    Written informed consent.

    Age of more than 18 years.

    Psorias 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) or more than 10.

    Exclusion of an active or latent tuberculosis by negative tuberculosis-skin-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, dithranol, corticosteroids, tar, tazarotene),
    ii) 4 weeks for conventional antipsoriatic systemic drugs (cyclosporine, methotrexate, fumarates, acitretin),
    iii) 4 weeks for uv-treatment,
    iv) 3 months for infliximab, golimumab, etanercept, and efalizumab,
    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 vaccination with a live-vaccine 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 and to avoid the use of artificial uv exposition (solarium).

    Use of anticonception in female study participants under study medication and up to at least 5 months after the last Humira injection.
    E.4Principal exclusion criteria
    According to approved label status of Humira:
    - Hypersensitivity against the active compound (i.e. adalimumab) or any other compound of Humira.
    - Active tuberculosis or other severe infections, alike sepsis and opportunistic infections.
    - Moderate to severe heart insufficiency (NYHA class III/IV).


    - HIV infection.
    - History of hepatitis B or hepatitis C.
    - Intake of immunosuppressive agents / drugs.
    - Indication for a demyelinating disease (e.g. multiple sclerosis) in the patient`s history or in the history of a family member.
    - Malignancies of recent relevance (incl. solid tumors, malignant hematopoetic diseases, lymphoproliferative diseases, melanocytic skin cancer).
    - Intolerance to biologics.
    - 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.
    - Serious other reason out of the investigator´s judgement.


    Absolute criteria for premature discontinuation are:
    - Occurence of preganancy.
    - Clinically significant worsening of disease, defined as an increase of PASI of > 50% as compared to the beginning 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.
    - 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 a standard "in-label" Humira treatment for 16 weeks. At that time point the individual PASI-response and the PASI-50-response- as well as PASI-75-response-rates will be recorded.
    - The primary study parameter is the analysis of the inflammatory topoproteome in skin tissue as detected by multi epitope ligand cartography (= MELC).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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 No
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 state12
    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 Decision2010-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-22
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