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    Summary
    EudraCT Number:2005-001243-28
    Sponsor's Protocol Code Number:P04320
    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:2005-05-19
    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 number2005-001243-28
    A.3Full title of the trial
    Study to determine the non inferiority of GROUP I (“high need”) compared to GROUP II (“low need”) concerning the efficacy of infliximab with respect to safety and tolerability in patients suffering from chronic plaque psoriasis (psoriasis vulgaris).
    A.3.2Name or abbreviated title of the trial where available
    Infliximab in high need versus low need psoriasis patients – IHELP-study
    A.4.1Sponsor's protocol code numberP04320
    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 Sponsoressex pharma GmbH
    B.1.3.4CountryGermany
    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.3.4Pharmaceutical 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 psoriaris (psoriasis vulgaris).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    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 objective of this study is to demonstrate equivalence of infliximab for GROUP I ("high-need") patients compared to GROUP II ("low-need") patients. This will be done by comparing the efficacy and safety in both groups. A non-inferiority approach will be applied.

    Primary objective
    Proportion of patients achieving a ≥ 75% improvement in PASI score from baseline to week 22 as compared between GROUP I and GROUP II patients.
    E.2.2Secondary objectives of the trial
    Proportion of patients achieving a Physician Global Assessment (PGA) score of cleared (1) or excellent (2) at week 2, 6, 14 and 22.
    Proportion of patients achieving a ≥ 90% improvement in PASI score from baseline to week 2, 6, 14 and 22.
    Change in patient´s and physician´s global assessment of nail involvement from baseline to week 22.
    Change in patient´s assessment of pruritus from baseline to week 2, 6, 14 and 22.
    Change in Dermatology Life Quality Index from baseline to week 6, 14 and 22.
    Change in SF-36 from baseline to week 6, 14 and 22.
    Overall treatment satisfaction assessed by patient at week 22.
    Proportion of patients with organ toxicity (refers to liver and kidney).
    Proportion of patients with adverse events.
    Incidence and intensity of adverse events.
    Overall tolerability assessed by patient at week 22.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient Inclusion Criteria

    The patient must meet the ALL criteria listed below for entry:

    Patient Inclusion Criteria at Screening Visit (Visit 0)
    1. Written informed consent by the patient for study participation, prior to protocol specific procedures.
    2. Patients who are 18 years of age or older at time of enrolment, may be male or female and of any race.
    3. Diagnosis of plaque-type psoriasis (psoriasis vulgaris) at least 6 months prior to screening.
    4. Plaque-type psoriasis covering at least 10% of total body surface area.
    5. PASI-Score of 12 or greater.
    6. GROUP I (“high need”) patients:
    Adult patients with moderate to severe plaque psoriasis who are either not controlled by, or are intolerant to or have contraindications to at least two currently available systemic therapies (e.g. photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept).

    GROUP II (“low need”) patients:
    Adult patients with moderate to severe plaque psoriasis who have undergone pre-treatment with no more than one currently available systemic therapy (e.g. photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept).
    7. Patients must have had a chest x-ray (preferably posteroanterior and lateral) within 3 months prior to first infusion with no evidence of malignancy, infection (e.g. tuberculosis) or fibrosis.
    8. Laboratory test results: liver enzymes (AST, ALT, GGT and alkaline phosphatase) must be within 1.5 times the upper limit of normal range (ULN), total bilirubin ≤ 1.0 ULN, serum creatinine < 1,5 mg/dl (must be available at baseline).
    9. Patients must agree to avoid prolonged sun exposure or other ultraviolet light sources during the study.

    10. Women of child-bearing potential must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for six months after stopping the medication. Acceptable methods of contraception include abstinence, condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g. hysterectomy or tubal ligation).
    11. Women of child-bearing potential must have a negative serum pregnancy test (beta-hCG) at Screening (must be available at Baseline).

    Patient Inclusion Criteria at Baseline Visit (Visit 1)

    1. Baseline PASI- Score of 12 or greater
    E.4Principal exclusion criteria
    Patient Exclusion Criteria

    The patient will be excluded from entry if ANY of the criteria listed below are met:

    Patient Exclusion Criteria at Screening Visit (Visit 0)

    Prior and Concomitant Diseases
    1. Patients suffering from active or latent tuberculosis. Prior to the start of treatment with infliximab tuberculosis needs to be excluded following the recommendations published by the German Paul Ehrlich Institut.
    2. Patients who have had or have a serious infection (e.g. abscess, pneumonia or pyelonephritis) or who have been hospitalized or received treatment with i.v. antibiotics during the previous 2 months.
    3. Patients who are known to be infected with human immunodeficiency virus, hepatitis B or C virus, prior or current opportunistic infections (within the last six months, H. zoster within the last 2 months).
    4. Patients suffering from congestive heart failure including medically controlled asymptomatic patients.
    5. History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
    6. Patients who have current signs and symptoms or history of systemic lupus erythematosus.
    7. Patients suffering from non-plaque psoriasis, e.g. erythrodermic, guttate or pustular forms. The presence of psoriasis-arthritis is no exclusion criterion.
    8. Patients suffering from current drug induced psoriasis (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers or calcium-channel-blockers). If the patient takes one of those substances on aregular basis, it should be on a stable dose for at least three weeks prior to baseline.
    9. Patients suffering from severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric diseases, that, in the opinion of the investigator, would interfere with the study evaluations or safe or optimal participation in the study.
    10. Any known malignancy during the last five years (except basal cell carcinoma), any history of lymphoproliferative disease.

    Prior Medication
    11. Patients who have received any systemic psoriasis therapy (e.g. immunosuppressant) or lithium within 28 days of baseline visit.
    12. Patients pretreated with etanercept or efalizumab within 28 days of Baseline.
    13. Patients previously treated with infliximab.
    14. Patients who have used topical treatments that could affect PASI evaluation (e.g. corticosteroids, anthralin, topical vitamin D derivates) within 2 weeks of baseline visit, except special areas like head or hands.
    15. Patients who have used any investigational drug within 3 months of Baseline.

    Others
    16. Patients with allergy/sensitivity to study drug or its excipients.
    17. Women who are breast-feeding, pregnant, or intend to become pregnant.
    18. Patients with any clinically significant condition or situation, other than the condition being studied.
    19. Patients who are participating in any other clinical study.
    20. Patients who are part of the staff personnel directly involved with this study.
    21. Patients who are a family member of the investigational study staff.

    Patient Exclusion Criteria at Baseline Visit (Visit 1)
    1. Patients who have used any investigational drug within 3 months before baseline.
    2. Patients who have received any systemic psoriasis therapy (e.g. immunosuppressant) or lithium within 28 days of baseline visit.
    3. Patients pretreated with etanercept or efalizumab within 28 days of Baseline.
    4. Patients who have used topical treatments that could affect PASI evaluation (e.g. corticosteroids, anthralin, topical vitamin D derivates) within 2 weeks of baseline visit, except special areas like head or hands.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is defined as the proportion of patients achieving a ≥ 75% improvement in PASI score from baseline to week 22 as compared between GROUP I and GROUP II patients.
    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 Information not present in EudraCT
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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 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 concerned80
    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
    The end of this clinical trial is defined by the last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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 state650
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    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)
    After termination of the study the patient will be treated by the physician according to the available standard therapeutic procedures in the respective study site.
    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 Decision2005-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-09-08
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