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    Summary
    EudraCT Number:2006-002670-22
    Sponsor's Protocol Code Number:P04807
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-04-15
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-002670-22
    A.3Full title of the trial
    Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).

    Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)
    A.3.2Name or abbreviated title of the trial where available
    UC SUCCESS
    A.4.1Sponsor's protocol code numberP04807
    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 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 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.3.10 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Imuran
    D.2.1.1.2Name of the Marketing Authorisation holderThe Wellcome Foundation
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameOverencapsulated Azathioprine (Imuran) 50 mg Tablet
    D.3.2Product code SCH 900050
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNazathioprine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboPowder for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    There are 2 parts. The primary objective of Part 1 of this study is to compare the proportion of subjects with moderate to severe active UC who achieve remission at Wk 16 on IFX/AZA combination therapy versus AZA monotherapy. Clinical remission at Wk 16 is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding one point, without the use of corticosteroids. The primary objective of Part 2 of this study is to determine whether remission in UC is better sustained by maintenance (q8w) or intermittent (upon relapse) infliximab treatment.
    E.2.2Secondary objectives of the trial
    Part 1 of this study are:
    - To compare the proportion of subjects with moderate to severe active UC who achieve remission at Wk 16 on infliximab monotherapy versus AZA monotherapy.
    - To compare the proportion of subjects with moderate to severe active UC who achieve remission at Wk 16 on IFX/AZA combination therapy versus IFX monotherapy.
    Secondary objectives for Part 2 are:
    - To assess the long-term safety and efficacy of maintenance versus intermittent therapy with 5 mg/kg IFX in a moderate to severe active UC population.
    -To assess mucosal healing
    - To determine the number of colectomies.
    - To determine the number of hospitalizations and unscheduled physician visits and surgeries due to UC.
    - To determine the number and outcome of surgical procedures due to UC.
    - To determine antibody formation to IFX in subjects who receive IFX monotherapy or IFX/AZA combination therapy as intermittent or maintenance IFX treatment in Part 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must meet ALL the criteria listed below for entry:
    1. Must be ≥18 years of age at the time of informed consent, of either sex, and of any race;
    2. Must have endoscopic evidence of UC, as determined by sigmoidoscopy, within 14 days prior to Baseline;
    3. Must have a total Mayo score of 6 to 12 points at Baseline;
    4. Must have responded inadequately to corticosteroid treatment (ie, the last or current UC flare did not respond adequately to a standard course of corticosteroids) with or without 5 aminosalicylic acid (5-ASA);
    5. Must be off corticosteroids or on a stable dose of corticosteroid for at least 2 weeks prior to enrollment. The maximal daily dose of corticosteroid at Baseline must not exceed the equivalent of 30 mg of prednisone;
    6. Must be naïve to infliximab and other tumor necrosis factor-alpha (TNF-α) antagonists;
    7. Must be either naïve to AZA/6-MP or have not received AZA/6-MP for at least 3 months before enrollment in the study;
    8 Are considered eligible according to the following tuberculosis (TB) screening 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 infliximab;
    d. Within 1 month prior to the first administration of inflixmab, either have negative tuberculin skin test, as outlined in Appendix 6 OR have a newly identified positive tuberculin test during screening in which active TB has been ruled out, and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of infliximab.
    e. Must have a chest X-ray (posterior-anterior and lateral views), taken within the 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
    9. Who have had UC for more than 10 years should have had a full colonoscopy within 2 years prior to Screening for the surveillance of dysplasia;
    10. Subjects’ Screening and Baseline clinical laboratory tests (complete blood count [CBC] and blood chemistries) must be within the following parameters:
    a. White blood cells (WBCs) ≥3.5 x 10 power of 9/L
    b. Neutrophils ≥1.5 x 10 power of 9/L
    c. Platelets ≥100 x 10 power of 9/L
    d. Serum creatinine <1.5 mg/dL (or <133 µmol/L)
    e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN), alkaline phosphatase and gamma-glutamyltransferase ≤2.5 x ULN
    f. Total bilirubin ≤1 x ULN
    11. Subjects who had been on antibiotics for the treatment of UC (eg, ciprofloxacin and metronidazole) must have been discontinued from them at least 3 weeks prior to Screening;
    12. Must be free of any clinically significant condition or situation, other than UC that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study;
    13. Are willing and able to adhere to the study visit schedule and other protocol requirements;
    14. Are capable of providing written informed consent, which must be obtained prior to conducting any protocol-specified procedures;
    15. Women of child-bearing potential and all men must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include 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 (eg, hysterectomy or tubal ligation). Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study;
    16. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening and a negative urine pregnancy test at Baseline.
    For direct entry into Part 2, the subject must meet ALL the criteria listed below for entry:
    Use the inclusion criteria from Part 1 number 1, 2, 4, 8, 9, 10, 11, 12, 13, 14, 15, 16
    The below are the additional criteria and the associated number as per the protocol
    3. Subjects must be in remission based on the total Mayo score with sigmoidoscopy performed within 14 days before Baseline without the use of corticosteroids.
    4. Subjects must have been on a scheduled IFX infusion every 8 Wks (± 1 Wk) for a maximum period of 6 mths.
    5. If subjects are treated with AZA/6-MP, the dose must be stable.
    E.4Principal exclusion criteria
    The subject will be excluded from entry if ANY of the criteria listed below are met:
    1. Have severe extensive colitis as evidenced by:
    a. Investigator judgment that the subject is likely to require colectomy within 12 wks of Baseline
    OR
    b. Subjects with at least 4 of these symptoms at Screening or Baseline visits as described in the protocol.
    2. Require, or are required within the 2 mths prior to baseline, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage or other conditions possibly confounding the evaluation of disease activity;
    3. Have severe, fixed symptomatic stenosis of the large or small intestine;
    4. Have current evidence of colonic obstruction or history within the 6 mths prior to baseline, confirmed with objective radiographic or endoscopic evidence of a stricture with resulting
    5. Have a history of colonic mucosal dysplasia;
    6. Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed;
    7. Have the presence of a stoma;
    8. Have a history of extensive colonic resection that would prevent adequate evaluation of clinical disease activity
    9. Have a positive stool culture for enteric pathogens, pathogenic ova or parasites within 4 months prior to Baseline unless subject has received treatment and had a negative stool examination 1 wk or longer after the end of treatment;
    10. Have a concomitant diagnosis of CHF, including medically controlled asymptomatic subjects;
    11. Have had serious infections within 2 mths of screening. Less serious infections need not be considered as an exclusion at the discretion of the investigator;
    12. Have had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to screening;
    13. Have a known infection with HIV and/or hepatitis B or hepatitis C;
    14. Have a history of a known allergy to murine proteins or allergy/sensitivity to study drug or its excipients;
    15. Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases;
    16. Have a known history of demyelinating disease suggestive of multiple sclerosis or optic neuritis;
    17. Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening);
    18. Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly;
    19. Have any current known malignancy or malignancy within 5 years prior to screening (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence);
    20. Have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling and infusion of study drug during the study period;
    21. Have had a known substance abuse or dependency (drug or alcohol) within 3 years of Screening;
    22. Require chronic (≥1 month) and frequent use (≥3 days per wk) of NSAIDs except low-dose aspirin for prevention of heart attacks, unstable angina, or transient ischemic attacks;
    23. Have other inflammatory diseases that might interfere with the evaluation of the ulcerative colitis;
    24. Who have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
    25. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 mths of screening.
    26. Have a chest X-ray within the 3 mths prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
    27. Have received any treatment listed in Table 2 (See Protocol) more recently than the indicated washout period prior to Screening;
    28. Who are participating in any other clinical study or who have received treatment with any investigational drug or device within 3 mths prior to Screening;
    29. Who is part of the staff or a family member of the staff personnel directly involved with this study.

    Subject Exclusion Criteria for Direct Entry into Part 2
    Use the exclusion criteria from Part 1 number 2 – 23, 28, 29. Use Table 2 from criteria 27 with the exception that Azathioprine or 6-MP is removed. All other prohibited meds apply.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for Part 1 of the study is the proportion of subjects in remission at Wk 16 (ie, total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, without the use of corticosteroids).The primary efficacy endpoint for Part 2 is the average remission rate over duration of treatment.
    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 Yes
    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) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Yes
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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 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 years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 600
    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 Decision2008-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-02-16
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