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    Summary
    EudraCT Number:2006-001579-40
    Sponsor's Protocol Code Number:P04440
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-04
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2006-001579-40
    A.3Full title of the trial
    Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab
    A.3.2Name or abbreviated title of the trial where available
    EUSpA
    A.4.1Sponsor's protocol code numberP04440
    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 France
    B.1.3.4CountryFrance
    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
    Spondyloarthropathies
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    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 study is to assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in patient treated with infliximab
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the patient monitoring through both clinical assessment and Power Doppler Ultrasonography during treatment phase and follow up.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Subjects must demonstrate their willingness to participate in the study and to adhere to dose and visit schedules and comply with its procedures by signing a written informed consent must have signed a written informed consent.
    2-If subject is a female volunteer of childbearing potential, she must have a negative serum pregnancy test at Screening.
    3-Men and women over 18 years of age of either sex, and any race.
    4-Subjects must be free of any clinically relevant disease other than SpA that would, in the principal investigator’s and/or sponsor’s opinion, interfere with the conduct of the study or study evaluations;
    5-Subjects must be elegible for anti-TNF treatment according to applicable local guidelines. For all patients chest X-ray and skin test results must be available at Week 0;
    6-Subjects must fulfil with the following criteria : European Spondyloarthropathy Study Group (E.S.S.G.) Classification Criteria, and/or Amor Criteria, and/or New Yourk modified criteria:
    6.1- For ESSG criteria:
    6.1.1 - One of the three clinical criteria should be present:
    • Low back pain at least three month’s duration improved by exercise and not relieved by rest.
    • Limitation of lumbar spine mobility in sagital and front planes.
    • Chest expansion decreased relative to normal values for age and sex
    7-Disease duration of spondyloarthritis over 6 months
    8-Incomplete response to NSAID
    9-BASDAI > 4 Including Item 2 (axial pain) >= 3 on a scale from 0 to 10
    10-At least one enthesitis assessed by PDUS
    11-History of elevated CRP (upper normal laboratory value) or inflammatory signal on MRI of spine or sacroilliac joint. For the MRI, the inflammatory status should have been determined within the last three months;
    12-Subject must confirm that he/she is practicing adequate contraception:
    (a) Female patients of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation).
    (b) Male patients who are sexually active must be using an acceptable method of contraception during the study. Acceptable methods of contraception include sterilization (eg, vasectomy), condoms (male and female) with a spermicidal agent, and when having relations with a female partner, she must also practice a medically acceptable method of contraception as described in the above section. Contraception must be used during the treatment period and for 6 months after receiving the last infusion, including condom use by male patients with pregnant partners.
    13-Subjects Week 0 laboratory tests must meet the following criteria:
    • Hemoglobin 9.0 g/dL or greater providing the low hemoglobin level is not due to diseases other than anemia of chronic inflammation
    • WBC equal to or greater than 3,500 / mm3
    • Neutrophils equal to or greater than 1,500 / mm3
    • Platelets equal to or greater than 100,000 / mm3
    • Liver enzyme levels less than or equal to 3 times the upper limit of normal
    • Serum creatinine less than or equal to 1.5 mg/dL
    E.4Principal exclusion criteria
    A subject who meets any of the following exclusion criteria will be disqualified for participation in the study, if this subject :
    1) Is a female who is pregnant, or intends to become pregnant during the study (or within 6 months after receiving the last infusion);
    2) Is a female who is nursing, or intends to be nursing during the study or within 6 month after having received the last infusion;
    3) Has childbearing potential without contraception throughout the study and for 6 months after receiving the last infusion.
    4) Has not observed the designated washout periods for any of the prohibited medications outlined in Section 6.2;
    5) Has any clinically significant deviation from the appropriate reference range in the physical examination, Chest X-ray, that, in the investigator’s judgment, may interfere with the study evaluation or affect subject safety;
    6) Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
    7) Is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study;
    8) Is allergic to or has sensitivity to the study drug or its excipients;
    9) Has Intolerance to or contraindication for infliximab.
    10) Has an history of allergy to murine products.
    11) Is uncooperative or has not signed the consent form.
    12) Can not understand the protocol.
    13) Has participated to a study within 3 months prior to inclusion.
    14) Had treatment with unstable doses of analgesic drugs (paracetamol, phenylbutazone, morphine) steroid, NSAID, or immunosuppressive agent, including methotrexate, within 4 weeks prior to inclusion.
    15) Had Intra articular steroid within 4 weeks prior to inclusion.
    16) Had Previous treatment with infliximab
    17)Had previous treatment with etanercept, adalimumab or any other TNF agent within 2 last months.
    18) Had an history of, ongoing or recurrent medical condition as follows :
    - Infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g. bronchectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremeting cystitis) open, draining or infected skin wound, or ulcer. Serious infection(s) (such as hepatitis, pneumonia or pyelonephritis) within 3 months prior to inclusion.
    - 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.
    - Active tuberculosis or previous history of non treated or insufficiently treated tuberculosis.
    Patient with a positive intradermal tuberculosis test according to the local recommendation
    For the patients who could have been in contact with a person having tuberculosis, the inclusion will be possible under specific conditions depending of local recommendations issued in France, Denmark, Hungary, Italy, Spain.
    - Herpes zoster (shingles) infection within 2 months prior to the first infusion
    - Opportunistic infections, e.g. cytomegalovirus, Pneumocystis carinii pneumonia, aspergillosis, histoplasmosis or atypical mycobacterium infection.
    19) Has any of the following clinical conditions :
    Severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases
    Known to be infected with HIV, hepatitis B or hepatitis C
    Known lymphoproliferative disease including lymphoma or signs suggestive of lymphoproliferative disease such as lymphadenoma of unusal size and localization or splenomegaly.
    Have received live (attenuated) vaccination during the last 30 days
    Have been treated with a monoclonal antibody or a fusion protein except etanercept, adalimumab or any other anti TNF agent
    20) Leukopenia < 3 500/mm3, Hemoglobin < 9g/dL, thrombopenia < 100 000/mm3.
    21) Congestive heart failure (CHF) i.e. stade III and IV of the NYHA;
    22) Scheduled surgical intervention at any time during the study.
    23) Multiple sclerosis or symptomatic demyelination of central nervous system.
    24) Subjects who have an history of drug abuse or alcoholism
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is the number of enthesitis between Week 4 and Week 12 evaluated using PDUS and the Imaging Data Process (IôDP) software.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    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 months
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2007-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-11-26
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