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    Summary
    EudraCT Number:2006-004971-37
    Sponsor's Protocol Code Number:STRU-09-06
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-02-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-004971-37
    A.3Full title of the trial
    Adalimumab for psoriasis patients who are non-responders to etanercept: An open-label study
    A.3.2Name or abbreviated title of the trial where available
    adalimumab for psoriasis patients who are non-responders to etanercept
    A.4.1Sponsor's protocol code numberSTRU-09-06
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's and St Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 40mg for injection in pre-filled syringe (adalimumab)
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for 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.3.9.3Other descriptive nameADALIMUMAB
    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) 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
    psoriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to test the hypothesis that psoriasis patients who are non-responders to etanercept achieve a clinically useful response with adalimumab.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Plaque-type psoriasis
    2. Non-responders to etanercept (ref: 2.2 Trial design)
    3. Male and female subjects >18 years of age
    4. Subjects must not have live vaccination during the study period.
    5. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
    a) Barrier methods (condoms or intrauterine device)
    b) Contraceptives (oral, parenteral, transdermal or implantable) starting from three months prior to study drug administration
    c) Vasectomized partner
    d) Total abstinence from sexual intercourse
    e) Must have a negative serum pregnancy test at Screening and Baseline.
    6. Normal chest x-ray (posterior–anterior and lateral) within 3 months prior to screening with no evidence of malignancy, infection or fibrosis.
    7. Subject must meet the tuberculosis (TB) eligibility assessment and screening requirement according to current British Association of Dermatologists guidelines.
    8. Subject is judged to be in good general health, as determined by investigator, based upon the results of a medical history, laboratory evaluations and the physical examination performed at screening and/or baseline.
    9. Ability and willingness to self-administer subcutaneous injections or have available qualified person(s) to administer subcutaneous injections
    10. Ability and willingness to give written informed consent or assent and to comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    1. Subject has erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
    2. Subject has a poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischaemic heart disease, congestive heart failure, cardiomyopathy, significant renal or hepatic disease, depression of such severity that the subject is a suicide risk or any other condition, which, in the opinion of the investigator, would put the subject at risk by participation in the study
    3. History of clinically significant drug or alcohol abuse within the last year
    4. History of iv drug abuse
    5. Pregnant or breast-feeding female
    6. History of lupus-like illness, neurologic symptoms suggestive of central nervous system (CNS) demyelinating diseases or blood dyscrasias
    7. Any other active skin disease or condition (e.g. bacterial, fungal or viral infection) that may interfere with assessment of psoriasis8. Subject receives or requires:
    a. UVB phototherapy, excessive sun exposure or the use of tanning booths for < 14 days prior to Baseline visit and during the study
    b. PUVA phototherapy < 2 weeks prior to baseline visit and throughout the study
    c. Systemic non-biologic therapies for psoriasis < 4 weeks prior to baseline visit and throughout the study.
    d. Investigational chemical agents must be discontinued at least 12 weeks or 5 half-lives prior to the baseline visit (whichever is longer)
    e. Oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
    9. History of any malignancy within the past 5 years, except successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in-situ of the cervix.
    10. History of active infection with Listeria or TB
    11. Any ongoing chronic or active infection or any episode of infection requiring hospitalization, treatment with iv antibiotics or antivirals within 30 days or oral antibiotics, antifungals or antivirals within 14 days prior to Screening
    12. Chronic hepatitis B requiring the current use of antiviral treatment, including antiretrovirals
    13. Chronic hepatitis C
    14. Known positive human immunodeficiency virus (HIV) status
    15. History of congenital immunodeficiencies
    16. Immune deficiency or immunocompromised
    17. Inability to comply with the study procedures or requirements
    18. Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug
    E.5 End points
    E.5.1Primary end point(s)
    PASI 50 improvement at week 12 of adalimumab therapy; that is 50% improvement in Psoriasis Area and Severity Index (PASI) in relative to start of etanercept.

    Secondarily we will assess 75% improvement in PASI at week 12 adalimumab therapy and mean percentage of PASI improvement relative to start of etanercept and relative to start of adalimumab.
    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 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 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 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
    End of the trial will be the last patient 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 months3
    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 state20
    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)
    These patients are high need patients. Therefore patients who respond to adalimumab (i.e. PASI 50 or above at 12 weeks) will continue adalimumab therapy. Patients who do not respond to adalimumab will have other alternative treatment for their psoriasis.
    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 Decision2007-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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