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    Summary
    EudraCT Number:2007-004157-28
    Sponsor's Protocol Code Number:M10-223
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-06
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-004157-28
    A.3Full title of the trial
    A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term open-label safety and efficacy study of Adalimumab in subjects
    with Ulcerative Colitis.
    A.4.1Sponsor's protocol code numberM10-223
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00573794
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbVie Deutschland 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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628 644475
    B.5.5Fax number0044 1628 644330
    B.5.6E-maileuclinicaltrials@abbott.com
    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 Humira 40 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd.
    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 nameadalimumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 331731-18-1
    D.3.9.3Other descriptive nameABT-Humira
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC) is a type of inflammatory bowel disease where
    inflammation develops in the large intestine (colon) and rectum.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 objective is to evaluate the long-term maintenance of
    response, safety and tolerability of repeated administration of
    adalimumab in subjects with ulcerative colitis who participated in and
    successfully completed Study M06-826 or Study M06-827.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess pharmacokinetics of adalimumab
    following
    subcutaneous administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must have successfully enrolled in and completed either the M06-826
    study or the M06-827 study.
    2. Female must be either not of childbearing potential, defined as postmenopausal for at least 1 year prior to the previous study (M06-826 study or M06-827 study), or
    surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
    or is of childbearing potential and practicing an approved method of birth control
    throughout the study and for 150 days after last dose of study drug. Examples of
    approved methods of birth control include the following:
    ● Condoms, sponge, foam, jellies, diaphragm or intrauterine device
    ● Oral, parenteral or intravaginal contraceptives
    ● A vasectomized partner
    3. Subject 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).
    4. Subject must be able to self-inject study medication or have a designee or
    healthcare professional who can inject the study medication.
    5. Subject is judged to be in generally good health as determined by the principal
    investigator based upon clinical evaluations performed during the preceding
    adalimumab ulcerative colitis study (M06-826 study or the M06-827 study).
    E.4Principal exclusion criteria
    A subject will be excluded from the study if he/she meets any of the following criteria:
    1. For any reason, subject is considered by the investigator to be an unsuitable
    candidate for participation in the M10-223 study.
    2. Female who is pregnant will be excluded from this study.
    3. Has not responded to weekly adalimumab therapy from Study M06-826 or
    M06-827.
    4. Female subject considering becoming pregnant during the study. There should be
    at least a 150-day period between the last dose of study drug and conception.
    5. History of malignancy other than a successfully treated non-metastatic cutaneous
    squamous cell, basal cell carcinoma and/or localized carcinoma in situ of the
    cervix. If the Week 52 (Study M06-826 or M06-827) colonoscopy/flexible
    sigmoidoscopy shows evidence of dysplasia or a malignancy, subject must not be
    enrolled in the study.
    6. History of listeriosis, histoplasmosis, chronic or active hepatitis B infection,
    human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
    central nervous system (CNS) demyelinating disease, or untreated tuberculosis
    (TB) (active and latent).
    7. Currently receiving total parenteral nutrition (TPN).
    8. Subject is not in compliance with prior and concomitant medication requirements
    (Section 5.2.3).
    9. Subjects with a poorly controlled medical condition, such as uncontrolled diabetes,
    unstable ischemic heart disease, moderate or severe congestive heart failure, recent
    cerebrovascular accidents and any other condition which, in the opinion of the
    investigator or sponsor, would put the subject at risk by participation in this study.
    10. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior
    to Baseline.
    11. Subjects with known hypersensitivity to the excipients of adalimumab as stated in the label.
    12. Current diagnosis of fulminant colitis and/or toxic megacolon.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in Mayo Scores and Partial Mayo Scores at the
    following time frames: Week 48, Week 96, Week 144, Week 192, Week
    240 and Week 292, Week 340 and Week 388.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48, Week 96, Week 144, Week 192, Week 240 and Week 292, Week 340 and Week 388 and other timepoints.
    E.5.2Secondary end point(s)
    Change from Baseline in IBDQ & SF-36; Work Productivity and Activity
    Impairment Questionnaire at the following time frames: Week 48, Week
    96, Week 144, Week 192, Week 240 and Week 292, Week 340 and Week 388 Colectomy rates, Cumulative number of unscheduled outpatient visits, AEs, Laboratory data, physical exams, and vital signs throughout course of the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48, Week 96, Week 144, Week 192, Week 240 and Week 292, Week 340 and Week 388 AEs, Laboratory data, physical exams; AEs, and vital signs throughout course of the study
    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 Yes
    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 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) 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) No
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Denmark
    France
    Italy
    Austria
    Netherlands
    New Zealand
    Norway
    Portugal
    Slovakia
    Sweden
    Australia
    Czech Republic
    Germany
    Hungary
    Puerto Rico
    Israel
    Poland
    Switzerland
    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
    This study will conclude approximately 12 weeks after the following criteria have been satisfied:
    ● Study drug receives country and local (if applicable) regulatory approval for
    UC.
    ● All applicable local reimbursement procedures are completed.
    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 years7
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 560
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 592
    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)
    Subjects who discontinue the study prematurely or who complete the
    M10-223 study period will receive a 70-day phone call to obtain follow-up
    information on any ongoing or new adverse events. Subjects who
    discontinue from this open-label study will be treated in accordance
    with the Investigator's best clinical judgment. The investigator will
    discuss treatment options with the subject.
    Refer to Section 5.4 of the protocol - Removal of Subjects from Therapy
    or Assessment.
    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 Decision2009-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-23
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