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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-000410-20
    Sponsor's Protocol Code Number:C0168T72
    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:2007-01-11
    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 number2006-000410-20
    A.3Full title of the trial
    A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis
    A.4.1Sponsor's protocol code numberC0168T72
    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 SponsorCentocor BV
    B.1.3.4CountryNetherlands
    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 BV
    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.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCNTO 168
    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
    Ulcerative colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    to evaluate the efficacy of a 3-dose induction regimen of infliximab in inducing a clinical response in pediatric subjects with moderately to severely active UC and to evaluate the safety profile of infliximab during induction and maintenance treatment.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of 2 infliximab maintenance dosing regimens (q8 and q12 weeks) in maintaining clinical remission.
    2. To evaluate the efficacy of 2 infliximab maintenance dosing regimens (q8 and q12 weeks) in maintaining clinical response.
    3. To evaluate the efficacy of a 3-dose induction regimen of infliximab in inducing clinical remission.
    4. To evaluate the efficacy of a 3-dose induction regimen of infliximab in inducing mucosal healing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Condensed:
    1. Are 6 to 16 years old, inclusive, if enrolled at a site that cannot treat and/or follow subjects once they become 18 years of age.
    OR
    Are 6 to 17 years old, inclusive, at all other sites.
    2. Have moderately to severely active UC, defined as a baseline Mayo score of 6 to 12, inclusive.
    3. Had UC diagnosed at least 3 months prior to screening.
    4. Must have the diagnosis of UC confirmed by the screening biopsy.
    5. Must have moderately to severely active UC confirmed during the screening sigmoidoscopy by a ≥ 2 endoscopy subscore of the Mayo score.
    6. Must meet at least 1 of the following criteria:
    a. Immunomodulators (6-MP or AZA):
    1) Be receiving adequate treatment* with 6-MP or AZA.
    OR
    2) Have failed to respond to an adequate dose of 6-MP or AZA.
    OR
    3) Have had medical complications and/or AEs from 6-MP or AZA that preclude the use of these medications at doses adequate to treat UC.
    OR
    b. Oral Corticosteroids:
    1) Be receiving with oral corticosteroids.
    OR
    2) Have failed to respond to an adequate dose of corticosteroids or to successfully taper corticosteroids.
    OR
    3) Have had medical complications and/or AEs from corticosteroids that preclude the use of these medications.
    7. Must be receiving 6-MP, AZA, or MTX because of the potential of these drugs to prevent the formation of antibodies to infliximab.
    8. Must meet concomitant medication stability criteria, as appropriate:
    a. 6-MP, AZA, MTX:
    1) Must have been receiving 1 of the immunomodulatory agents 6-MP, AZA, or MTX for 8 weeks prior to assessment of the baseline Mayo score.
    2) If 6-MP, AZA, or MTX has been recently discontinued, it must have been stopped at least 4 weeks prior to Mayo screening procedures.
    b. Corticosteroids:
    1) If receiving oral or rectal corticosteroids, the dose must have been stable for at least 2 weeks prior to Mayo screening procedures.
    2) If oral or rectal corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to Mayo screening procedures.
    c. 5-ASA compounds:
    1) If receiving oral or rectal 5-ASA compounds, the dose must have been stable for at least 2 weeks prior to Mayo screening procedures.
    2) If oral or rectal 5-ASA compounds have been recently discontinued, they must have been stopped at least 2 weeks prior to Mayo screening procedures.
    d. Bulking or stool softening agents: If using bulking or stool softening agents chronically, the dose must have been stable for at least 2 weeks prior to Mayo screening procedures and a stable dose must be maintained until Week 54.
    9. If receiving enteral nutrition, must have been on a stable regimen for 2 weeks prior to Mayo screening procedures.
    10. Must have discontinued the use of antibiotics for the treatment of UC at least 3 weeks prior to Mayo screening procedures.
    11. Must have at least 1 of the following:
    a. A well-documented history of chicken pox by medical chart review or careful interview of parents or guardian, OR
    b. An uncertain history of chicken pox with a positive varicella antibody titer, OR
    c. A history of varicella vaccination with positive varicella antibody titer.
    12. If at increased risk for colon cancer must either have had a colonoscopy to assess the presence of dysplasia within 1 year prior to the first infusion at Week 0 or a colonoscopy to assess the presence of malignancy at the screening visit
    13. Have screening laboratory tests that meet the following criteria:
    a. Hemoglobin ≥ 8.5 g/dL
    b. White blood cell count ≥ 3.5 x 10E9/L
    c. Neutrophils ≥ 1.5 x 10E9/L
    d. Platelets ≥ 100 x 10E9/L
    e. AST, ALT, and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test.
    14. Male subjects who are sexually active and female subjects of childbearing potential who are sexually active must agree to use adequate birth control measures during the study and for 6 months after receiving the last infusion. All female subjects who menstruate and/or who are e 10 years old must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Week 0. Female subjects who are younger than 10 must also have a negative serum pregnancy test at screening and a negative urine pregnancy test at Week 0 if the clinician suspects that puberty is imminent.
    15. Are considered eligible according to the following 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.
    d. Within 1 month prior to the first administration of study agent, have a negative tuberculin skin test.
    e. Have a chest radiograph, taken within 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.
    E.4Principal exclusion criteria
    Condensed:
    1. Have severe extensive colitis as evidenced by:
    a. Investigator judgment that the subject is likely to require colectomy within 12 weeks of baseline.
    OR
    b. Symptom complex at screening or baseline visits that includes at least 4 of the following:
    1) diarrhea with ≥ 6 bowel movements/day with macroscopic blood in stool
    2) focal severe or rebound abdominal tenderness
    3) persistent fever (≥ 37.5°C)
    4) tachycardia (≥ 90 beats/minute)
    5) anemia (≥ 8.5 g/dL)
    2. Have UC limited to the rectum only or to < 20 cm of the colon.
    3. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
    4. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
    5. Have had a chest radiograph within 3 months prior to the first administration of
    study agent that shows an abnormality suggestive of a malignancy or current
    active infection, including TB.
    6. Have had a nontuberculous mycobacterial infection or opportunistic infection
    within 6 months prior
    to screening.
    7. Have had a live viral or bacterial vaccination within 3 months prior to screening.
    8. Have a positive stool culture for enteric pathogens
    9. Have or have had serious infection in the 3 months prior to screening.
    10. Have immune deficiency syndrome.
    11. Have documented HIV, AIDS-related complex, or AIDS and/or hepatitis B or
    hepatitis C.
    12. Have signs or symptoms of any other medical condition that might predispose the
    subject to significant infection.
    13. Receiving total parenteral nutrition within the 2 weeks prior to Mayo screening procedures.
    14. Received parenteral corticosteroids within 2 weeks prior to Mayo screening procedures.
    15. Require chronic and frequent use of antimotility agents for control of diarrhea
    16. Have used laxatives, except for preparation for endoscopy or other procedures,
    within 1 week prior to Mayo screening procedures.
    17. Were treated with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil
    within 8 weeks prior to screening.
    18. Have used any investigational drug within 4 weeks prior to screening or within
    5 half-lives of the investigational agent, whichever is longer.
    19. Have received prior treatment with infliximab or any other TNF antagonist
    20. Have known history of allergy to murine proteins or any previous treatment with
    murine products.
    21. Have ever received natalizumab or other agents that target alpha-4-integrin.
    22. Have ever received agents that deplete B cells or T cells.
    23. Presence of a stoma.
    24. Presence or history of a fistula.
    25. Require, or required within the 2 months prior to screening, 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 benefit from infliximab treatment.
    26. Have severe, fixed symptomatic stenosis of the large or small intestine.
    27. Presence or history of colonic obstruction within the 6 months prior to baseline,
    confirmed by objective radiographic or endoscopic evidence of a stricture with
    resulting obstruction.
    28. History of extensive colonic resection that would prevent adequate evaluation of the effect of infliximab on clinical disease activity.
    29. History of colonic mucosal dysplasia.
    30. 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.
    31. Presence or history of any malignancy within 5 years of screening.
    32. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location or splenomegaly.
    33. Concomitant diagnosis or history of CHF, including medically controlled asymptomatic CHF.
    34. Have signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
    hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral
    diseases.
    35. History of systemic lupus erythematosus.
    36. Received an organ transplant.
    37. History of demyelinating disease, such as multiple sclerosis or optic neuritis.
    39. Have poor tolerability of venipuncture or lack of adequate venous access for
    required blood sampling and infusion of study drug during the study period.
    40. Are pregnant, nursing, or planning pregnancy within 18 months after screening.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response at Week 8
    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 Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    The end of the study is defined as the final visit (Week 62) of the last subject.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 2007-01-11. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Signed written consent from the parent/legal guardian and assent from the child (age at which assent is given may vary by IRB/EC) must be obtained prior to any
    protocol-specified procedures.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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)
    None.
    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 Decision2007-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
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