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    The EU Clinical Trials Register currently displays   35865   clinical trials with a EudraCT protocol, of which   5890   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002078-23
    Sponsor's Protocol Code Number:M06-829
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-22
    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 ConcernedGermany - PEI
    A.2EudraCT number2006-002078-23
    A.3Full title of the trial
    A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.
    A.4.1Sponsor's protocol code numberM06-829
    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 (Abbott)
    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 No
    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 pre-filled PEN
    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.3.11 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    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 and delineate the safety and efficacy profile of adalimumab (Humira pre-filled syringe or Humira pre-filled PEN) when administered to subjects with moderate to severe Crohn's Disease.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months (16 weeks).
    2. Inadequate response to conventional therapy for Crohn's Disease in the opinion of and as documented by the treating physician.
    3. Harvey Bradshaw Index score greater or equal to 7.
    4. Males and females greater or equal to 18 and less than or equal to 75 years of age at the Baseline visit.
    5. 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, intrauterine device, subdermal implantation
    ·Oral or parenteral contraceptives (including hormonal vaginal devices and transdermal patches) for three months prior to study drug administration
    ·A vasectomized partner
    6.If female, subject is not breast-feeding throughout the study and for 150 days after the last dose.
    7. 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).
    8. 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.
    9. Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
    E.4Principal exclusion 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), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active 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. Subjects with abscess or suspicion of abscess, defined as fever and/or anal pain.
    6. 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.
    7. Subject with an ostomy or ileoanal pouch.
    8. Subject who has short bowel syndrome as determined by the investigator.
    9. Subject who is currently receiving total parenteral nutrition (TPN).
    10. Females who are pregnant or will not discontinue breast-feeding.
    11. Subject who has received any investigational chemical agent in the past 30 days or 5 half-lives prior to Baseline (whichever is longer).
    12. Subject who has received any investigational biological agent within 5 half-lives prior to Baseline.
    13. Subject who has an active infection or has had systemic antibiotic, antiviral, or antifungal treatment within 3 weeks prior to Baseline for infection. Subjects are allowed to be on ciprofloxacin or metronidazole for their non-infectious Crohn's symptoms.
    14. Subject with a history of clinically significant drug or alcohol abuse in the last year.
    15. 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.
    16. Subjects with positive C. difficile stool assay.
    17. Subject who has previously used infliximab or any anti-TNF within 8 weeks of Baseline.
    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 greater or equal to 3 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. 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 been on cyclosporine (iv, oral), tacrolimus (any form) or Mycophenolate mofetil within 8 weeks of Baseline are excluded.
    26. Subjects with any prior exposure to Tysabri® (natalizumab).
    27. Subjects with known hypersensitivity to the excipients of adalimumab as stated in the label.
    28. Subject is not in compliance with Prior Therapy requirements
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints will include assessments of adverse events, laboratory data, physical exams and vital signs throughout the study.
    Efficacy Endpoints are changes in Harvey-Bradshaw Index total score, SIBDQ, and WPAI assessed from Baseline to Weeks 2, 4, 8, 12 and 20. For efficacy evaluation, the Harvey-Bradshaw Index total score, assessment of draining fistulas, SIBDQ, WPAI, assessment of extra-intestinal manifestations and unscheduled outpatient visits, emergency room visits and hospitalization. Each variable will be assessed at Weeks 2, 4, 8, 12 and 20.
    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 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 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.8.4.1Number of sites anticipated in Member State concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    last visit of the last subject
    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 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 months9
    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 state250
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1000
    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)
    Normal treatment for condition
    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 Decision2006-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-05
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