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    Summary
    EudraCT Number:2009-015749-22
    Sponsor's Protocol Code Number:ADATOP
    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:2010-09-20
    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 number2009-015749-22
    A.3Full title of the trial
    A prospective, monocentric clinical trial with adalimumab for topical treatment in chronic wounds
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, monocentric clinical trial with adalimumab for topical treatment of chronic wounds
    Eine prospektive, monozentrische klinische Prüfung von Adalimumab zur topischen Behandlung von chronischen Wunden
    A.3.2Name or abbreviated title of the trial where available
    ADATOP
    A.4.1Sponsor's protocol code numberADATOP
    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 SponsorUniversity of Leipzig
    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 supportAbott Germany
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Centre Leipzig - KKS
    B.5.2Functional name of contact pointCoordination Centre for Clinical Tr
    B.5.3 Address:
    B.5.3.1Street AddressHaertelstr. 16-18
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04107
    B.5.3.4CountryGermany
    B.5.4Telephone number+493419716247
    B.5.5Fax number+493419716259
    B.5.6E-mailyasmine.breitenstein@zks.uni-leipzig.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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd, United Kingdom
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic stasis ulcer
    E.1.1.1Medical condition in easily understood language
    Chronic wound
    chronische Wunde
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10047246
    E.1.2Term Venous stasis ulcer
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    Is there a significant influence on wound healing in chronic wounds after regular treatment did not improve wound healing any further?
    E.2.2Secondary objectives of the trial
    Secondary questions of the study concern:
    - occurrence of new or aggravation of an existent infection.
    - pain associated with chronic wound
    - occurrence of potential contraindications
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - at least one chronic wound without signs of infection
    - age >=50 years
    - at least 6 months peristence without significant recovery despite optimal wound care, the wound must measure between 2.24cm2 and 64cm2
    - written informed consent
    E.4Principal exclusion criteria
    - pregnant and nursing women,
    - pre-existing severe hepatic or renal insufficiency
    - pre-existing of hepatitis
    - chronic severe focus of infection
    - severe wound infection
    - known hypersensitivity to Adalimumab or other components of the IMP
    - signs of latent or active tuberculosis
    - decompensated cardiac insufficiency (NYHA III/IV)
    - lack of treatment compliance
    - active demyelinating or other neurological disorder
    - malignant or lymphoproliferative disorder
    - known autoimmune disorder
    - consumption of other immunosuppresive drugs
    - women of child bearing potential (< 2 years after last menstruation)
    - concurrent participation in other studys
    - individuals dependent on investigator
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of wound area under serial treatment with Adalimumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of application series, i.e. day 8 (+/-2)
    E.5.2Secondary end point(s)
    - course of wound area during treatment
    - wound pain (visual analogue scale)
    - occurence or incidence of infections
    - results of mikrobiologic swab, in case of clinical suspicion of infection
    - development of possible contraindications (each visit; following the SmPC)
    - development of TNF-alpha-antibodies
    - other (S)AE
    E.5.2.1Timepoint(s) of evaluation of this end point
    every visit, i.e. days 1-8 and Follow-up: 4 and 12 weeks after last application of IMP
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    provided in the protocol, chapter 3.4, page 16
    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 months5
    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.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state18
    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)
    Patients who complete or drop out of this clinical trial are treated at the recent standard for venous stasis ulcer. This care is performed by specialized wound clinic in the department for dermatology in the clinic of the University Leipzig or a general practioner.
    Patienten, die aus der klinischen Prüfung ausscheiden, werden nach dem bisher geltenden Standard zur Behandlung für chronische Wunden weiter versorgt. Ihre Betreuung wird entweder in der spezialisierten Wundambulanz der Uni-Hautklinik oder bei einem niedergelassenen Arzt fortgesetzt.
    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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-30
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