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    Summary
    EudraCT Number:2007-005905-23
    Sponsor's Protocol Code Number:M10-261
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-005905-23
    A.3Full title of the trial
    A Multi-center, Randomized, Double-blind, Placebo − controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
    A.3.2Name or abbreviated title of the trial where available
    M10-261, FINAL 30Nov07
    A.4.1Sponsor's protocol code numberM10-261
    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 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.3.4Pharmaceutical form Solution for 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.3.9.1CAS 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) 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.IMP: 2
    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.3.4Pharmaceutical form Solution for 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.3.9.1CAS 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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    At a selected study site in Germany, a subset of seventy−five (75) subjects that have signed the appropriate Informed Consent Form will be enrolled for intensive pharmacokinetic sampling for MTX and non-MTX-subjects. A maximum of forty-five (45) MTX-subjects are to be enrolled for intensive pharmacokinetic sampling, the remaining thirty (30) will consist of non-MTX − subjects. Additional subjects may be required to ensure that seventy-five complete sets of samples are received.
    E.3Principal inclusion criteria
    A subject will be eligible for study participation if he/she meets the following criteria:
    1. Subject is > 18 years of age.
    2. Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification
    criteria and has a disease duration for a minimum of three months.
    3. Subject must meet the following two criteria:
    a. At least 6 swollen joints out of 66 assessed.
    b. At least 6 tender joints out of 68 assessed
    4. If a subject is on MTX (PO, SC or intramuscular [IM]), the doses must be stable
    for at least 4 weeks prior to Screening blood draw and follow standard
    recommendations for MTX treatment (ie according to the packaging insert)
    5. If a subject is on a DMARD other than MTX, the subject must discontinue it for at
    least 28 days before the Baseline Visit/first dose of investigational product (IP)
    (wash-out period).
    6. Female subjects either not of childbearing potential, defined as postmenopausal (at
    least 1 year since last menses) or surgically sterile (bilateral tubal ligation, bilateral
    oophorectomy or hysterectomy), or are of childbearing potential and practicing
    one of the following methods of birth control throughout the study and for
    150 days after study completion:
    ● Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
    ● Contraceptives (oral, parenteral, patch) for three months prior to study drug
    administration)
    ● A vasectomized partner
    7. Female subjects of childbearing potential must have a negative serum pregnancy
    test at the Screening visit and a negative urine pregnancy test at Baseline/first IP
    dose.
    8. Subject is judged to be in good general health as determined by the Principal
    Investigator or designee based upon the results of medical history, laboratory
    profile, physical examination, CXR, and 12-lead electrocardiogram (ECG)
    performed at Screening.
    9. Subjects will be evaluated for latent TB infection with a purified protein derivative
    (PPD) test and CXR. For this protocol, evidence of latent TB infection is defined
    as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement.
    Subjects who demonstrate evidence of latent TB infection, irrespective of Bacille
    Calmette − Guérin (BCG) vaccination status, and negative CXR findings for active
    TB and/or suspicious CXR findings will be allowed to participate in the study
    provided that one of the following conditions are satisfied;
    ● Prophylactic treatment is initiated before administration of study drug. In
    general it is recommended, but not mandated, to start 2 weeks before study
    drug administration, however the course of prophylaxis need not be completed
    prior to the onset of study drug. Prophylactic treatment will be according to
    the United States Centers for Disease Control (CDC) recommended
    preventive therapy for TB or other local guidelines. Prophylactic treatment
    should be captured on the concomitant medications page in the case report
    form (CRF) and in the source documents.
    ● Subject has documented prophylactic treatment for TB and so need not repeat
    this treatment.
    ● Active TB has been ruled out.
    10. Subjects must be able and willing to provide written informed consent and comply
    with the requirements of this study protocol.
    11. Subjects must be able and willing to self-administer SC injections or have a
    qualified person available to administer SC injections.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study.
    1. Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab,
    etanercept, certolizumab pegol or golimumab) including adalimumab.
    2. Subject has been treated with Intra-articular or parenteral administration of
    corticosteroids in the preceding 4 weeks from Baseline visit/first IP dose. Inhaled
    corticosteroids for stable medical conditions are allowed. Oral of <=10 mg/d
    prednisone equivalent are allowed
    3. Subject has undergone joint surgery within the preceding two months of Screening
    Visit (at joints to be assessed within the study).
    4. Subject has a history of acute inflammatory joint disease of different origin other
    than RA (eg, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age
    17 years).
    5. Subject has a history of an allergic reaction or significant sensitivity to constituents
    of study drugs (adalimumab, MTX, or matching placebo).
    6. Subject has been treated with any investigational drug of a "chemical" nature
    within one month prior to Baseline/1st IP dose.
    7. Subject has been treated with any investigational biologic agents (eg, Rituximab,
    Tocilizumab, Abatacept, etc)
    8. Subject has a poorly controlled medical condition, such as uncontrolled diabetes,
    unstable heart disease, congestive heart failure, recent cerebrovascular accidents
    and any other condition which, in the opinion of the Investigator, would put the
    subject at risk by participation in the study.
    9. Subject has a history of clinically significant hematologic (eg, severe anemia,
    leukopenia, thrombocytopenia), renal, liver disease (eg, fibrosis, cirrhosis,
    hepatitis), or gastroenteric ulcer.
    10. Subject has history of neurologic symptoms suggestive of central nervous system
    (CNS) demyelinating disease and/or diagnosis of central demyelinating disease.
    11. Subject has history of cancer or lymphoproliferative disease other than a
    successfully treated non-metastatic cutaneous squamous cell or basal cell
    carcinoma and/or localized carcinoma in situ of the cervix.
    12. Subject has a history of listeriosis, histoplasmosis, active TB, persistent chronic
    infections, or recent active infections requiring hospitalization or treatment with
    intravenous (IV) anti-infectives within 30 days or oral anti-infectives within
    14 days prior to the Baseline visit/first IP dose.
    13. Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
    14. Subject is known to have any acquired immune deficiency (ie, HIV infection) or
    untreated congenital immunodeficiency. Abbott Study Designated Physician
    approval required for specific congenital immunodeficiency cases.
    15. Female subject who is pregnant or breast-feeding or considering becoming
    pregnant during the study or for 150 days after the last dose of study medication.
    16. Subject has a history of clinically significant drug or alcohol usage in the last year
    or cannot maintain an alcohol intake of 30 g a day or less throughout the study.
    One standard drink is defined as 180 mL/6 oz (approx. 10 g) of wine,
    360 mL/12 oz (approx. 15 g) of regular beer, or 45 mL/1.5 oz (approx. 10 g) of
    spirits.
    17. Screening clinical laboratory analyses show any of the following abnormal
    laboratory results:
    ● Aspartate transaminase (AST) or alanine transaminase (ALT) >2.0x the upper
    limit of normal (ULN).
    ● Serum total bilirubin > 1.5 mg/dL, unless the subject has a known deficiency;
    or
    ● Creatinine > 1.5 mg/dL
    ● Evidence of chronic Hepatitis B.
    18. Subject is considered by the Investigator, for any reason, to be an unsuitable
    candidate for the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analysis will be a comparison of the response rates according to the ACR20 criteria. The improvement in RA (fulfillment of ACR20 criteria) at Week 12 will be compared to the findings before 1st study drug administration (Baseline).
    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 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 Yes
    E.6.13.1Other scope of the trial description
    non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dose of the same IMP
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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-study is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is longer.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 424
    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 Decision2008-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-15
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