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    Summary
    EudraCT Number:2007-000535-26
    Sponsor's Protocol Code Number:P05133
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-000535-26
    A.3Full title of the trial
    swiTching from etAnercept to iNfliximab in the treatment of moderate to severe psoriasis; a multi-center, open label trial evaluating the efficacy, tOlerance and safety (TANGO)
    A.3.2Name or abbreviated title of the trial where available
    TANGO
    A.4.1Sponsor's protocol code numberP05133
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 S.p.A.
    B.1.3.4CountryItaly
    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 concentrate 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.3.9.1CAS number 170277313
    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 psoriasis that are resistent to etanercept ab initio or have failed 24 weeks of treatment with etanercept
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To assess the efficacy of infliximab therapy (infusion of 5 mg/kg at weeks 0, 2, 6, 14, 22), evaluated through PASI 75 (defined as the proportion of subjects achieving at least a 75% PASI – Psoriasis Area and Severity Index - improvement from the baseline) at visit 5 (week 10). In those patients in whom the previous treatment with etanercept was not successful, according to inclusion criteria.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of infliximab through the following parameters:
    • PASI (Psoriasis Area and Severity Index) 50, 75,90 and 100
    • BSA (Body Surface Area Affected)
    • SAPASI (Self-Administered PASI)
    • VAS (Visual Analog Scale) to assess itch intensity

    To assess the impact of psoriasis and the treatment with Infliximab on the quality of life through:

    • DLQI (Dermatology Quality of Life Index)
    • SKINDEX 29

    To evaluate the tolerance and safety of infliximab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be ≥18 to 75 years of age at Screening, of either sex, and of any race.

    2. Subjects must have had a diagnosis of moderate to severe plaque psoriasis at least 6 months prior to Screening (subjects with concurrent psoriatic arthritis may be enrolled).

    3. Subjects resistant or patient who must have failed 24 weeks of treatment with etanercept. (Definition of resistant patient: patient who has not modified or presents an increase in his PASI score or BSA affected after 12 weeks of etanercept treatment. Definition of patient failure: patient who has not reached PASI 75 or presents BSA ≥ 10 at Screening visit (V1) after 24 weeks of etanercept treatment.

    4. Subjects who has not reached PASI 75 at Screening visit (V1) after 24 weeks of etanercept treatment or resistant ab initio to etanercept.

    5. Subjects must agree to avoid prolonged sun exposure or artificial ultraviolet light sources during the study.

    6. Subjects must comply with the requirements of the screening and diagnosis Tubercolosis Skin Test (according to procedure described in section 8.12 of the present protocol).
    Subjects are considered eligible according to the following criteria:

    a. Have no history of latent or active TB prior to screening;

    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;

    c. 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;

    d. Two negative tuberculin skin tests; one positive tuberculin skin test in association with appropriate treatment for latent TB initiated prior to or simultaneously with the first administration of study medication

    7. Subjects must have had a chest x-ray (posterior-anterior and lateral) at visit 1 or within 3 months prior to vist 1 with no evidence of malignancy, infection or fibrosis.

    8. Subjects’ Screening clinical laboratory tests must be within the following parameters:

    a. Hemoglobin ≥10 g/dL
    b. White blood cells ≥3.5 x 109/L
    c. Neutrophils ≥1.5 x 109/L
    d. Platelets ≥100 x 109/L
    e. Serum creatinine <1.5 mg/dL
    f. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase ≤1.5 x upper limit of normal range
    g. Total bilirubin ≤1.5 x upper limit of normal range

    9. Subjects must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that would interfere with the study evaluations.

    10. Subjects must be willing to participate to the study and to adhere to study procedures by signing the written informed consent.

    11. Women of childbearing potential and all men must be using adequate birth control measures and must continue using such measures until 6 months after receiving the last dose of study medication.

    12. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at visit 1 and a negative urine pregnancy test at visit 2.
    E.4Principal exclusion criteria
    1. Subjects who achieved PASI 75 or who have had BSA < 10 after 24 weeks of etanercept treatment.

    2. Subjects who have current drug-induced psoriasis (f.i., a new onset of psoriasis or an exacerbation of psoriasis due to iatrogenic factors).

    3. 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 the last dose of study medication.

    4. Subjects previously treated with infliximab.

    5. Subjects who are currently taking or have taken the following drugs within the specified time frame prior to Screening (see Section 6.2):

    a. any live or attenuated virus or bacterial vaccinations received within 3 months prior to visit 1

    b. any systemic medications/treatments that could affect psoriasis or clinical evaluations within 4 weeks prior to visit 1.

    c. lithium within 4 weeks prior to visit 1

    d. any topical medications/treatments that could affect psoriasis or PASI evaluations within 2 weeks prior to visit 1. The only allowed treatments are emollient/moisturizing lotion and shampoos containing salicylic acid. Subjects should not use these topical agents the day prior to study visit. Non-medicated shampoos may be used on the day of a visit.

    6. Subjects who have a concomitant diagnosis of congestive heart failure (CHF), including medically-controlled and or asymptomatic subjects.

    7. Subjects who have a history of chronic or recurrent infectious disease, including: chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic cystitis), open skin wounds/ulceration that are draining or infected.

    8. Subjects who have had or have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for this infection during the 2 months prior to visit 1.

    9. Subjects who have or have had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to Visit 1.

    10 Subjects who have or have had a Herpes zoster infection within 2 months prior to visit 1.

    11. Subjects who are known to be infected with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).

    12. Subjects who have a history of any clinically significant AEs (including allergic reactions) to murine or chimeric proteins or human/murine recombinant products.

    13. Subjects who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.

    14. Subjects who have a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.

    15. Subjects who have current signs and symptoms or history of systemic lupus erythematosus.

    16. Subjects who have a transplanted organ (with the exception of a corneal transplant >3 months prior to visit 1).

    17. Subjects who have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.

    18. Subjects who have any malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence).

    19. Subjects who are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.

    20. Subjects who are known to have had a substance abuse (drug or alcohol) problem within the previous 3 years.

    21. Subjects who have a history of any clinically significant adverse reactions (including allergic reactions) to paracetamol/acetaminophen or histamine H1 receptor antagonist.

    22. 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.

    23. Subjects who have used any investigational drugs within 4 weeks of Screening.

    24. Subjects who are participating in any other clinical study.

    25. Subjects who are staff personnel directly involved with this study.

    26. Subjects who are family members of the investigational study staff.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is the PASI 75 response rate (PASI 75 is defined as the proportion of subjects achieving a ≥75% improvement in PASI from Baseline value) at visit 5 (Week 10).
    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 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) No
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 subject is considered to have completed the study EITHER upon the completion of the last protocol-specified visit or contact (eg. phone contact with the principal investigator or qualified designee), OR upon receiving the last dose of the study medication, if that occurs after the last protocol-specified visit or contact.
    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 months6
    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 months6
    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 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 2007-08-29. Yes
    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 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2007-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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