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    Summary
    EudraCT Number:2005-005291-32
    Sponsor's Protocol Code Number:M05-769
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2005-005291-32
    A.3Full title of the trial
    A Multi-Center, Randomized, Double-Blind, Placebo − Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.
    A.4.1Sponsor's protocol code numberM05-769
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    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 nameHumira
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdalimumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 160
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10057035
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of therapy with adalimumab 40mg eow, starting at Week 4 after a 160mg/80mg loading dose, on mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease and to delineate the safety of adalimumab when administered to subjects with Crohn's Disease.
    E.2.2Secondary objectives of the trial
    Secondary efficacy variables will be Crohn's Disease Endoscopic Index of Severity (CDEIS) scores, the Simple Endoscopic Score for Crohn's Disease (SES-CD) and ulcer counts, CDAI score, number of subjects discontinued from steroids, total IBDQ scores, WPAI scores, SF − 36 dimension scores, and Unscheduled Outpatient Visits, Emergency Room Visits and Hospitalizations Questionnaire. For detailed secondary endpoints which will be assessed please see section 5.3.4.2. of the protocol.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be eligible for study participation if he/she meets the following criteria:
    1. Diagnosis of Crohn's Disease for greater than 4 months.
    2. A diagnosis of ileocolonic Crohn's Disease confirmed by endoscopy or radiologic evaluation within 3 years of Baseline.
    3. For subjects that have had operations in the ileocolonic region of the intestine after documented diagnosis of ileocolonic disease, postoperative recurrence of the disease must be documented.
    4. Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3 on the Ulcerated Surface subscore of the SES-CD.
    5. Crohn's Disease Activity Index (CDAI) score of greater than or equal to 220 and less than or equal to 450.
    6. Males and females older than or equal to 18 and younger than or equal to 75 years of age at the Baseline visit.
    7. If female, subject is either not of child bearing potential, defined as post menopausal for at least (1) year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control during the study and for 150 days after the last dose:
    ● Condoms, sponge, foam, jellies, diaphragm or intrauterine device
    ● Oral or parenteral contraceptives for three months prior to study drug administration
    ● A vasectomized partner
    8. If female, subject is not breast-feeding throughout the study and for 150 days after the last dose.
    9. Subject or his/her legal representative has voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
    10. Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.
    11. Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
    12. Subjects must agree to undergo up to 4 endoscopies.
    13. Subjects may be included if they used infliximab or any anti-TNF agent (except adalimumab) and a) responded and then stopped the agent, b) responded and lost their response, c) responded and became intolerant, or d) did not tolerate the anti-TNF agent.
    E.4Principal exclusion criteria
    A subject will be excluded from the study if he/she meets any of the following criteria:
    1. History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma − in-situ of the cervix.
    2. History of listeria, human immunodeficiency virus (HIV), Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or untreated TB.
    3. Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator and Abbott Medical Monitor.
    4. Subject with symptomatic known obstructive strictures.
    5. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
    6. Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
    7. Subject who has short bowel syndrome as determined by the investigator.
    8. Subject who is currently receiving total parenteral nutrition (TPN).
    9. Females who are pregnant or will not discontinue breast-feeding.
    10. Subject who has received any investigational chemical agent in the past 30 days or 5 half-lives prior to Baseline (whichever is longer).
    11. Subject who has received any investigational biological agent in the past 3 months or 5 half-lives prior to Baseline (whichever is longer).
    12. Subject who has had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Baseline for all non-Crohn's related infections.
    13. Subject with a history of clinically significant drug or alcohol abuse in the last year.
    14. Subjects with a poorly controlled medical condition such as: uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or the sponsor, would put the subject at risk by participation in the protocol.
    15. Subjects with positive C. difficile stool assay.
    16. Subject who has previously used infliximab or any anti-TNF within 8 weeks of Baseline.
    17. Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded.
    18. Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
    19. Screening laboratory and other analyses show any of the following abnormal results:
    ● Electrocardiogram (ECG) - with clinically significant abnormalities;
    ● Aspartate transaminase (AST) or alanine transaminase (ALT) >1.75 x the upper limit of the reference range;
    ● Total bilirubin ³3 mg/dL;
    ● Serum creatinine >1.6 mg/dL;
    20. Subjects on Imuran® (azathioprine), 6 MP, or MTX who have not been on stable doses of these medications for at least 4 weeks prior to Baseline. For subjects on those medications, doses are to remain stable during the entire course of the study. Additionally, for subjects on those medications, subjects must have been on azathioprine, 6 MP, or MTX for at least 12 weeks prior to Baseline. Moreover, subjects who have been on azathioprine, 6 MP, or MTX who have discontinued these medications within 12 weeks of Baseline are excluded.
    21. Subjects on aminosalicylates, mesalamine, sulfasalazine, or Crohn's related antibiotics who have not been on stable doses of these medications for at least 4 weeks prior to Baseline. In addition, subjects on aminosalicylates, sulfasalazine or Crohn's related antibiotics who have discontinued these medications within 4 weeks of Baseline are excluded.
    22. Subjects on prednisone >40 mg/day (or equivalent) and subjects who were not on stable doses for two weeks prior to Baseline. In addition, subjects who discontinued prednisone (or equivalent) within 2 weeks of Baseline are excluded.
    23. Subjects on budesonide >9 mg/day and subjects who were not on stable doses of budesonide for at least 2 weeks prior to Baseline. In addition, subjects who discontinued budesonide within 2 weeks of Baseline are excluded.
    24. Subjects currently taking both budesonide and prednisone (or equivalent) are excluded.
    25. Subjects who have undergone therapeutic enemas within 2 weeks prior to Baseline are excluded.
    26. Subjects who have been on cyclosporine (iv, oral), tacrolimus (any form) or Mycophenolate mofetil within 8 weeks of Baseline are excluded.
    27. Subjects with any prior exposure to Tysabri® (natalizumab).
    28. Subjects with known hypersensitivity to the excipients of adalimumab as stated in the label.
    29. Subject is not in compliance with Section 5.2.3.2 of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the presence or absence of mucosal ulceration by endoscopy. The primary outcome analysis will be a comparison of the proportions of subjects without mucosal ulceration on endoscopy in the adalimumab and placebo groups at Week 12.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Opportunity to drop to open-label therapy for non-responder. Please see section 5.1 of the protocol.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 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.8.6 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 years
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months21
    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 Information not present in EudraCT
    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 2006-06-28. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject or his/her legal representative has voluntarily signed and dated an informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 130
    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 Decision2006-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-27
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