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    Summary
    EudraCT Number:2005-005367-28
    Sponsor's Protocol Code Number:P04563
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-06-22
    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 ConcernedFinland - Fimea
    A.2EudraCT number2005-005367-28
    A.3Full title of the trial
    A Long-Term Efficacy and Safety Study of Infliximab in the Treatment of Moderate to Severe Plaque-type Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    RESTORE II
    A.4.1Sponsor's protocol code numberP04563
    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 SponsorSchering-Plough Research Institute, a division of Schering Corporation
    B.1.3.4CountryUnited States
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor B.V.
    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.3.1Product nameRemicade
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfliximab
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Moderate to severe plaque-type psoriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess the efficacy of long-term maintenance therapy versus intermittent therapy with infliximab (5 mg/kg by body weight) in adult subjects (aged 18-75 years) diagnosed with moderate to severe plaque-type psoriasis who have remained on 22 weeks of treatment with infliximab in Study P04271, and completed the full 26 weeks of Study P04271.
    E.2.2Secondary objectives of the trial
    The secondary objective of this trial is to assess the long-term safety of maintenance therapy versus intermittent therapy with infliximab in subjects with moderate to severe plaque-type psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must meet ALL of the criteria listed below for entry:
    1. Subjects must have met all inclusion/exclusion criteria in Study P04271.
    2. Subjects must have been originally randomized to infliximab in Study P04271.
    3. Subjects must have completed the full 26 weeks of Study P04271.
    4. Subjects must have remained on infliximab for the full 22 weeks of treatment
    in Study P04271.
    5. Subjects must have achieved an improvement in Psoriasis Area and Severity
    Index (PASI) score ≥75% from Baseline of Study P04271 to Week 26 of
    Study P04271.
    6. Subjects must agree to avoid prolonged sun exposure and avoid use of
    tanning booths or other ultraviolet light sources during the study.
    7. Subjects are considered eligible according to the following tuberculosis (TB)
    criteria:
    a. Have no signs or symptoms suggestive of active TB upon medical
    history and/or physical examination;
    b. Have had no recent close contact with a person with active TB or, if
    there has been such contact, will be referred to a physician
    specializing in TB to undergo additional evaluation and, if warranted,
    receive appropriate treatment for latent TB prior to or simultaneously
    with the first administration of study medication.
    8. Subjects’ Baseline (Visit 1) clinical laboratory tests (CBC, blood chemistry,
    and urinalysis) must be within the following parameters:
    a. Hemoglobin ≥10 g/dL
    b. White blood cells ≥3.5 x 10 9/L
    c. Neutrophils ≥1.5 x 10 9/L
    d. Platelets ≥100 x 10 9/L
    e. Serum creatinine <1.5 mg/dL (or <133 µmol/L)
    f. Aspartate aminotransferase, alanine aminotransferase, alkaline
    phosphatase, and gamma-glutamyltransferase levels as outlined in
    Table 2
    g. Total bilirubin < 2 x upper limit of normal
    9. Subjects must be free of any clinically significant disease (other than plaque-type
    psoriasis or psoriatic arthritis) that would interfere with the study
    evaluations.
    10. Subjects must be willing to give written informed consent and be able to
    adhere to dose and visit schedules.
    11. Women of childbearing potential and all men must be using adequate birth
    control measures (eg, abstinence, oral contraceptives, intrauterine device,
    barrier method with spermicide, or surgical sterilization) and must continue
    using such measures until 6 months after receiving the last infusion of study
    medication.
    12. Female subjects of childbearing potential must have a negative urine
    pregnancy test at Baseline.
    E.4Principal exclusion criteria
    The subject will be excluded from entry if ANY of the criteria listed below are
    met:
    1. Subjects who have any significant ongoing AEs or AEs from P04271 that
    would prohibit further treatment with infliximab at the time of entry.
    2. Subjects originally randomized to methotrexate or subjects who received
    methotrexate at any time during their participation in Study P04271.
    3. Subjects who have non-plaque forms of psoriasis (eg, erythrodermic, guttate,
    or pustular).
    4. Subjects who have current drug-induced psoriasis (eg, a new onset of
    psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel
    blockers, or lithium).
    5. Female subjects who are pregnant, nursing, and both men and women who
    are planning pregnancy during the study period or during the 6 months after
    receiving of the last infusion of study medication.
    6. Subjects who are in a situation or have any condition that, in the opinion of
    the investigator, may interfere with optimal participation in the study.
    7. Subjects who are staff personnel directly involved with this study.
    8. Subjects who are family members of the investigational study staff.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the PASI75 (Psoriasis Area and Severity Index) response rate at Week 128 (PASI75 is defined as the proportion of subjects achieving a ≥75% improvement in PASI from the original Baseline in Study P04271).
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    approved long-term maintenance therapy
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The Data Monitoring Committee (DMC) will review safety data periodically. There is no plan to present efficacy data and no plan to stop the study for lack of efficacy. However, if there are any significant safety risks associated with either of the two treatment regimens, the DMC may request review of unblinded efficacy data and may recommend that the sponsor either stop the study or modify the treatment strategies.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 500
    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)
    N/A
    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 Decision2006-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-01-09
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