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    Summary
    EudraCT Number:2007-004227-37
    Sponsor's Protocol Code Number:27808
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-004227-37
    A.3Full title of the trial
    A PHASE IV MULTICENTRE RANDOMISED DOUBLE BLIND PLACEBO CONTROLLED TRIAL TO EVALUATE THE SAFETU AND EFFICACY OF RAPTIVA IN THE TREATMENT OF SUBJECTS IWTH MODERATE TO SEVEERE PLAQUE PSORIASIS INVOLVING HADNS AND OR FEET WITH OR WITHOUT PUSTULES
    A.3.2Name or abbreviated title of the trial where available
    TRUST STUDY: RAPTIVA IN HAND & FOOT PSORIASIS
    A.4.1Sponsor's protocol code number27808
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorMERCK SERONO INTERNATIONAL SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 RAPTIVA
    D.2.1.1.2Name of the Marketing Authorisation holderIND.FARMACEUTICA SERONO SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNEfalizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SUBJECTS WITH CHRONIC (DISEASE HITORY OF AT LEAST 6 MONTHS FROM DIAGNOSIS) MODERATE TO SEVERE PLAQUE PSORIASIS INVOLVING THE HAND AND/OR FEET (PGA - H&F RATINGS OF 3 OR 4) AT SCREENING WHO HAVE FAILED TO RESPOND TO OR WHO HAVEA CONTRAINDICAITON TO OR ARE INTOLERANT TO OTHER SYSTEMIC THERAPIES INCLUDING CYCLOSPOSCORING (PGA-H&F)MAJOR EQUAL 3 WHO HAVE FAILED TO RESPOND TO, OR WHO HAVE A CONTRAINDICATION TO, OR ARE INTOLERANT TO OTHER SYSTEMIC THERAPIES INCLUDING CYCLOSPORINE, METHOTREXATE, PUVA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    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
    TO EVALUATE THE SAFETY AND EFFICACY OF RAPTIVA AGAINST PLACEBO TO CONTROL CHRONIC MODERATE TO SEVERE PLAQUE-TYPE PSORIASIS INVOLVING HANDS AND/OR FEET SCORING PGA (PGA - H&F) MAJOR EQUAL 3 IN SUBJECTS NOT SUITABLE FOR OTHER SYSTEMIC THERAPIES INCLUDING CYCLOSPORINE, METHOTREXATE AND PUVA
    E.2.2Secondary objectives of the trial
    TO EVALUATE THE EVOLUTION OF PSORIASIS EVENTS (REBOUND OR EXACERBATION) DURING RAPTIVA THERAPY OR AFTER ITS DISCONTINUATION FOR ANY CAUSE. EXACERBATION: CONTINUOUS AND SLOW DISEASE WORSENING EITHER DURING OR AFTER TREATMENT AND OCCURING EITHER WITHIN PRE-EXISTING PLAQUES AT PREVIOUSLY UNINVOLVED SITES OR AS NEW MORPHOLOGIES OF DISEASE COMPARED TO BASELINE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects aged 18 years, suffering moderate to severe chronic
    plaque-type psoriasis involving hands and/or feet with or without pustules who are not suitable
    for treatment with systemics including cyclosporine, methotrexate and PUVA. Without
    previous exposure to Raptiva and must have least 3 months of washout for biologics or other
    investigational drugs. Systemic treatment must be discontinued at least during the screening
    period. Subjects must have no history of uncontrolled infection or opportunistic infection,
    must be seronegative for viral diseases at screening, and must have no history of active
    tuberculosis, malignancies, or important medical conditions conflicting the participation of the
    trial.
    E.4Principal exclusion criteria
    Hypersensitivity to efalizumab or to any of the excipients
    2) Current use of any prohibited therapy (systemic or topical treatments for psoriasis,
    immunosuppressive drugs, any other experimental drug, etc)
    3) Previous or current exposure to Raptiva®
    4) History of or ongoing alcohol or drug abuse
    5) History of or an ongoing opportunistic infection (e.g. systemic fungal infection, parasites)
    or any other serious infection. This includes diagnoses that required more than 2 weeks of
    therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6
    months. In addition, if the subject is currently receiving antibiotics, antivirals, or
    antifungals for an infection or for suppression or prophylaxis for any diagnosis, the subject
    will be excluded.
    6) Seropositivity for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency
    virus (HIV). Subjects will undergo testing during screening, and any subjects who are
    seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded.
    7) History of active or latent tuberculosis within one year prior to screening (to be determined
    by assessment according to national and/or local recommendation).8) Presence or history of malignancy, including lymphoproliferative disorders.
    9) Pregnancy or breast-feeding
    10) History of hepatic cirrhosis, regardless of cause or severity
    11) History of thrombocytopenia, haemolytic anaemia, clinically significant anaemia, a WBC
    count <4,000 cells/µL or >14,000 cells/µL, a haematocrit (HCT) <30% or a haemoglobin
    (Hgb) level <11 g/dL, a platelet count <150,000 cells/µL
    12) Hepatic enzyme levels Q3 times the upper limit of normal or serum creatinine level Q2
    times the upper limit of normal
    13) Vaccination with a live or live-attenuated virus or live or live-attenuated bacteria vaccine
    within the 14 days prior to the first dose of Raptiva®
    14) Any medical condition that, in the judgment of the Investigator, would jeopardise the
    subject’s safety following exposure to investigational medicinal product (Raptiva® or
    placebo equivalent) or would significantly interfere with the Subject’s ability to comply
    with the provisions of this protocol.
    15) Other specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or
    predominant for of psoriasis.
    16) Immunodeficiencies.
    E.5 End points
    E.5.1Primary end point(s)
    PROPORTION OF SUBJECTS ACHIEVING A PGA-H&F RATING OF CLEAR, ALMOST CLEAR OR MILD AT WEEK 12 OF TREATMENT, IN THE RAPRTIVA GROUPS AS COMPARED TO THE PLACEBO GROUP
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    CHIUSURA DEL DATABASE CLINICO
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 168
    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)
    TRATTAMENTO DOPO LA CONCLUSIONE DELLO STUDIO SARA' A DISCREZIONE DEL MEDICO
    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 Decision2008-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-03-03
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