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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   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:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-08
    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 ConcernedItaly - Italian Medicines Agency
    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.3.2Name or abbreviated title of the trial where available
    Protocol C0168T72
    A.4.1Sponsor's protocol code numberC0168T72
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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
    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 holderSCHERING PLOUGH SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 number5
    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) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to severely active 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 10009900
    E.1.2Term Colitis ulcerative
    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 objectives of this study are to evaluate the efficacy of a 3-dose induction regimen of infliximab in inducing 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
    The major secondary objectives are:

    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 Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Aged 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 aged 6 to 17 years old, inclusive, at all other sites.

    2. Affected by moderately to severely active UC, defined as a baseline Mayo score of 6 to 12, inclusive.

    3. Affected by UC diagnosed at least 3 months prior to screening..

    4. Diagnosis of UC confirmed by the screening biopsy.

    5. Affected by moderately to severely active UC confirmed during the screening sigmoidoscopy by a &#8805; 2 endoscopy subscore of the Mayo score.

    6. Must meet at least 1 of the following criteria:

    a. Immunomodulators (6-MP or AZA): Be receiving adequate treatment with 6-MP or AZA, or have failed (within the last 5 years) to respond to an adequate dose of 6-MP or AZA, or have had medical complications and/or AEs from 6-MP or AZA (within the last 5 years) that, in the judgment of the subject’s physician, preclude the use of these medications at doses adequate to treat UC.

    b. Oral Corticosteroids: Be receiving adequate treatment with oral corticosteroids or have failed (within the past 2 years) to respond to an adequate dose of corticosteroids or to successfully taper corticosteroids (ie, had a flare of disease on tapering to < 10 mg of prednisone on 2 separate occasions), or have had medical complications and/or AEs from corticosteroids (within the past 2 years) that, in the judgment of the subject’s physician, preclude the use of these medications.

    7. Must be receiving (at no specific dose) 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 for a. 6-MP, AZA, MTX, b. Corticosteroids, c. 5-ASA compounds, d. Bulking or stool softening agents.

    9. Must have discontinued the use of antibiotics for the treatment of UC at least 3 weeks prior to Mayo screening procedures.

    10. Must have a well-documented history of chicken pox or an uncertain history of chicken pox with a positive varicella antibody titer, or an history of varicella vaccination with positive varicella antibody titer.

    11. If at increased risk for colon cancer must either have had a colonoscopy to assess the presence of dysplasia.

    12. Have screening laboratory tests that meet the following criteria: Hemoglobin &#8805; 8.5 g/dL; White blood cell count &#8805; 3.5 x 109/L; Neutrophils &#8805; 1.5 x 109/L; Platelets &#8805; 100 x 109/L

    13. Male subjects who are sexually active and female subjects of childbearing potential who are sexually active must agree to use adequate birth control measures.

    14. 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.

    15 Are considered eligible according to the following TB screening criteria: have no history of latent or active TB prior to screening.; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination, have had no recent close contact with a person with active TB, within 1 month prior to the first administration of study agent, have a negative tuberculin skin test, have a chest radiograph (posterior-anterior view), 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
    Subjects meeting any of the following criteria may not be enrolled:

    1. Have severe extensive colitis as evidenced.

    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.

    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 (such as hepatitis, pneumonia, or pyelonephritis) in the 3 months prior to screening. Less serious infections (such as acute upper respiratory tract infections [colds]) need not be considered exclusionary criteria at the discretion of the investigator.

    10. Have immune deficiency syndrome.

    11. Have documented HIV, AIDS-related complex, or AIDS and/or hepatitis B or hepatitis C.

    12. Receiving total parenteral nutrition (TPN) within the 2 weeks prior to Mayo screening procedures.

    13. Received parenteral corticosteroids within 2 weeks prior to Mayo screening procedures.

    14. Require chronic and frequent use of antimotility agents for control of diarrhea .

    15. Have used laxatives, except for preparation for endoscopy or other procedures, within 1 week prior to Mayo screening procedures.

    16 Were treated with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to screening.

    17. Have used any investigational drug within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

    18. Have received prior treatment with infliximab or any other TNF antagonist.

    19. Have known history of allergy to murine proteins or any previous treatment with murine products.

    20. Have ever received natalizumab or other agents that target alpha-4-integrin.

    21. Have ever received agents that deplete B cells (eg, rituximab) or T cells (eg, alemtuzamab).

    22. Presence of a stoma.

    23. Presence or history of a fistula.

    24. Require, or required within the 2 months prior to screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess or other conditions possibly confounding the evaluation of benefit from infliximab treatment.

    25. Have severe, fixed symptomatic stenosis of the large or small intestine.

    26. Presence or history of colonic obstruction within the 6 months prior to baseline.

    27. History of extensive colonic resection.

    28. History of colonic mucosal dysplasia.

    29. 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.

    30. Presence or history of any malignancy within 5 years of screening.

    31. History of lymphoproliferative disease.

    32. Concomitant diagnosis or history of CHF, including medically controlled asymptomatic CHF.

    33. Have signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.

    34. History of systemic lupus erythematosus.

    35. Received an organ transplant.

    36. History of demyelinating disease, such as multiple sclerosis or optic neuritis.

    37. Are pregnant, nursing, or planning pregnancy (both males and females) within 18 months after screening.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response is defined as a decrease from baseline in the Mayo score by &#8805; 30% and

    &#8805; 3 points, with a decrease in the rectal bleeding subscore of &#8805; 1 or a rectal bleeding

    subscore of 0 or 1.

    Clinical remission is defined as a Mayo score &#8804; 2 points, with no individual subscore > 1.

    By this definition, subjects in clinical remission will have a rectal bleeding subscore of

    either 0 or 1.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Information not present in EudraCT
    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 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.8.6 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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months2
    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 months2
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 40
    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 Decision2007-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-24
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