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    Summary
    EudraCT Number:2004-004691-37
    Sponsor's Protocol Code Number:
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-01-11
    Trial 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 ConcernedIreland - HPRA
    A.2EudraCT number2004-004691-37
    A.3Full title of the trial
    Etanercept in Psoriasis and Psoriatic Arthritis: a single center, open-label study in 15 patients.
    A.4.1Sponsor's protocol code number
    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 SponsorSt Vincents University Hospital
    B.1.3.4CountryIreland
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Enbrel (etanercept) A centralised product with Marketing Authorisation in 25 EU Member States EU MA granted 3 February 2000
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameEnbrel (etanercept)
    D.3.2Product code 0881
    D.3.4Pharmaceutical form Powder and solvent for 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.3.8INN - Proposed INNetanercept
    D.3.9.1CAS number N/Applicable
    D.3.9.2Current sponsor code0881
    D.3.9.3Other descriptive nameTNR-001;TNFR:Fc;rhuTNFR:Fc
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typePharmacotherapeutic group: selective immunosuppresive agents ATC code: L04 AA11
    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 and Psoriatic Arthritis
    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
    The proposed study is a single center, open label study of 15 patients with PsA and cutaneous Ps treated with a 3-month course of Etanercept (Enbrel).
    The aims of this study are to assess the effect of TNF inhibition with Etanercept on:
    ­ The clinical features of PsA disease activity
    ­ The clinical features of Ps disease activity
    ­ Synovial immunohistologic changes
    ­ Cutaneous immunohistologic changes
    ­ Change of MRI features from baseline of the affected knee joint
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    ­ Patients must give written informed consent, given prior to any study-related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.
    ­ Patients between the ages 18 and 80 years, with a joint disease onset after 16 years old
    ­ Female patients must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either
    ­ being post-menopausal or surgically sterile, or
    ­ using an accepted form of contraception.
    Confirmation that the patient is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to study day 1. A pregnancy test is not required if the patient is post-menopausal or surgically sterile.

    ­ Patients with PsA of > 3 months duration defined by the following criteria:
    Peripheral arthritis alone or in combination with sacroiliitis
    Active arthritis with >3 swollen joints and >3 tender joints considered capable of responding to drug therapy. At least one of the inflamed joints should be a knee joint.
    ­ An evaluable psoriatic skin lesion, diagnosed by a consultant rheumatologist or dermatologist.
    ­ Negative serum test for rheumatoid factor.
    E.4Principal exclusion criteria
    ­ Patients who have received systemic treatment with biologics, including cytokines/anti-cytokines within three months prior to study day 1.
    ­ Patients who have participated in any other investigational study (and received active compound) or received an experimental therapeutic procedure considered by the investigator to interfere with the study within three months prior to study day 1.
    ­ Patient with inadequate bone marrow reserve, defined as:
    · leukocytes ≤ 3.5 x 109/L,
    · thrombocytes ≤ 100 x 109/L, and
    · haemoglobin ≤ 5.5 mmol/L (8.9 g/dL).
    ­ Patients treated with prednisone >10 mg/day or a treatment change in the prednisone regime during the 28 days prior to Study Day 1.
    ­ Positive antibodies against double stranded DNA.
    ­ Patients taking more than one NSAID or a treatment change in the NSAID regime during the 28 days prior to Study Day 1.
    ­ Patients previously treated with chlorambucil or cyclophosphamide.
    ­ Patients treated with DMARDS during the 28 days prior to Study Day 1 or cyclosporin within 8 weeks of Study Day 1 or leflunomide within 8 weeks of Study Day 1 (Patients taking leflunomide must undergo a cholestyramine washout consisting of Cholestyramine 8 Grams three times per day, or activated powdered charcoal four times a day, for eleven days followed by a two week waiting period prior to the screening visit, or complete an 8 week washout prior to the screening visit).
    ­ Patients with inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase ≥ 1.5 times the upper limit of the normal values.
    ­ Inadequate renal function, defined by serum creatinine > 150 micromol/L.
    ­ Planned major surgery (eg. joint replacement) within the duration of the treatment period of the study.
    ­ History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the skin).
    ­ Have history of active Tuberculosis, or currently active Tuberculosis or currently undergoing treatment for Tuberculosis.
    ­ Active severe infection (or non-severe infections at the discretion of the Investigator).
    ­ Opportunistic infection in the preceding 3 months.
    ­ Clinically significant serious abnormalities on electrocardiography or chest X?ray.
    ­ Other serious concomitant disorders incompatible with the study (at the discretion of the Investigator).
    ­ Have history of drug (including narcotics) abuse, or current active problems with alcohol abuse.

    For Articular Component:
    ­ Patients with seropositive, symmetric polyarthritis.
    ­ Patients treated with intra-articular injections with corticosteroids within 28 days prior to Study Day 1.
    ­ Patients with Arthritis Mutilans.
    ­ Patients who are wheelchair bound or bedridden.

    For Cutaneous Component:
    ­ Patients with guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
    ­ Evidence of skin conditions other than psoriasis (e.g. eczema).
    ­ Topical therapies and oral retinoids within 14 days of study day 1.
    ­ Phototherapy within 28 days of study day 1.
    ­ Clinically significant psoriasis flare during screening or at the time of enrollment
    E.5 End points
    E.5.1Primary end point(s)
    The primary response endpoint is the detection of an efficacy signal expressed as a change from baseline. Responses will be established on the basis of the clinical, immunohistologic and MRI changes at week 12 from baseline.

    For the articular component a clinical response will be evaluated using:
    ­ Physician’s global assessment of disease activity (improvement: decrease by at least 1 unit; worsening increase by at least 1 unit)
    ­ Patient’s global self-assessment of disease activity (improvement: decrease by at least 1 unit; worsening: increase by at least 1 unit)
    ­ Tender joints score (improvement; decrease by at least 30%; worsening: increase by at least 30%)
    ­ Swollen joints score (improvement: decrease by at least 30%; worsening: increase by at least 30%)
    ­ ACR 20, 50 and 70 response criteria will be applied and the evolution of individual PsARC/ACR parameters will be followed over the duration of the study.

    The response to treatment of the cutaneous components of disease will be based on the change of the Psoriatic Area and Severity Index (PASI) at Week 12 from baseline. To have a PASI response, patients must improve at least by 75% in their PASI score between baseline and the end of treatment (Week 12).

    The evolution of individual PASI parameters will be followed over the duration of the study. Finally, a target lesion will be photographed at baseline and compared with findings at 12 weeks.

    With the exception of target lesion photography, all of the above assessments will be obtained at each patient visit (screening 0, 2, 8 and 12 weeks). In addition, blood will be obtained at each visit for FBC, ESR and CRP.

    Synovial immunohistologic change
    Using a standard mini-arthroscopic procedure, synovial tissue will be obtained from an inflamed knee joint at 0 and at 12 weeks. Tissue will be embedded in OCT for standard immunohistochemical staining to include cell surface markers (CD3, CD4, CD8, CD68), cytokines (IL-1, TNF) and markers of angiogenesis (Factor VIII, VEGF and its receptors, angiopoietins, avß3). Staining will be quantified and compared at each time point using quantitative methods and/or image analysis. All of the synovial immunohistologic analysis will be performed at the end of the study.

    Skin immunohistologic change
    In patients with evaluable skin lesions, a 6mm punch, lesion biopsy will be obtained at 0 and 12 weeks. Half of the biopsy will be embedded in OCT for immunohistologic staining as outlined above. All of the skin immunohistologic analysis will be performed at the end of the study.

    MRI of the affected knee joint
    While plain x-rays of affected joints will be obtained at baseline it is not expected that x-rays will show any major change during the short period of follow up. The MRI findings in PsA are more dramatic sometimes showing substantial bone oedema and periosteal / entheseal change. It is likely that MRI findings are also considerably more sensitive to change. Gadolinium–enhanced MRI will be obtained in all subjects at baseline and at 12 weeks.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 Information not present in EudraCT
    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
    The end of the trial is the last follow-up visit for safety of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    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 2005-01-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state15
    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 Decision2005-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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