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    The EU Clinical Trials Register currently displays   37950   clinical trials with a EudraCT protocol, of which   6228   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2008-004398-16
    Sponsor's Protocol Code Number:W10-046
    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:2008-08-12
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2008-004398-16
    A.3Full title of the trial
    A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberW10-046
    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 SponsorAbbott Scandinavia AB
    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.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. name Humira
    D. 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 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.3.9.2Current sponsor codeABT-Humira
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    Adalimumab has the indication for life-long treatment of RA but can adalimumab be discontinued in patients who are in stable clinical remission (DAS28<2.6) with retained low disease activity or will the RA symptoms relapse? If relapse occurs, how is the response if adalimumab is reinstituted?
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the proportion patients with RA in stabel clinical remission (DAS28<2.6) after treatment with adalimumab in combination with methotrexate in whom it is possible to discontinue adalimumab treatment without an increase in disease activity.
    E.2.2Secondary objectives of the trial
    To study the frequency of flare after adalimumab discontinuation and to study the effect of reinstitution of adalimumab after flare.

    To study the safety of adalimumab in reinstitution of therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subject is of age ³ 18 years.
    2) Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification
    and has a documented positive RF test or erosion on radiograph of hands or feet.
    3) Subject is currently treated with adalimumab and MTX (at least 10 mg/week;
    orally or subcutaneously) and has received both for at least 6 months (MTX dose
    stable for at least 2 months).
    4) Subject is in remission as defined by DAS28<2.6 for at least the 3 past months,
    based on assessments at baseline and on at least one more occasion 3-6 months
    prior to baseline, documented in patient record or registry.
    5) Concomitant DMARD (MTX excluded) or oral corticosteroid therapy has been stable
    for at least 3 months at study entry.
    6) Female subject is 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 is 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 entry
    ● A vasectomized partner.
    7) Subject is judged to be in good general health as determined by the Principal
    Investigator based upon the results of medical history, laboratory profile and
    physical examination.
    8) Subjects must be able and willing to provide written informed consent and comply
    with the requirements of this study protocol.
    9) 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
    1) Subject has been treated with intra-articular or parenteral administration of
    corticosteroids in the preceding 4 weeks. Inhaled corticosteroids for stable
    medical conditions are allowed.
    2) Oral prednisone or prednisone equivalent > 10 mg/day at baseline.
    3) Subject has undergone joint surgery within the preceding two months (at joints
    to be assessed within the study).
    4) Subject has a history of acute inflammatory joint disease of different origin other
    than RA (e.g., mixed connective tissue disease, seronegative spondyloarthritis,
    psoriatic arthritis, Reiter's syndrome, fibromyalgia, systemic lupus erythematosus
    or any arthritis with onset prior to age 17 years).
    5) Subject has been treated with any investigational drug within 30 days or 5 half
    lives – whichever is longer prior to study entry (baseline visit).
    6) Subject has a poorly controlled medical condition, such as uncontrolled diabetes,
    unstable ischemic heart disease, moderate to severe 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.
    7) Subject has a history of clinically significant hematologic (e.g., severe anemia,
    leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis,
    8) Subject has history of neurologic symptoms suggestive of central nervous system
    (CNS) demyelinating disease and/or diagnosis of central demyelinating disease.
    9) 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.
    10) Subject has a history of listeriosis, histoplasmosis, untreated 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.
    11) Subject is known to have immune deficiency, history of HIV or is
    12) Female subject who is pregnant or breast-feeding or considering becoming
    pregnant or breast feeding during the study or for 150 days after the last dose of
    study medication.
    13) 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.
    14) Baseline clinical laboratory analyses show any of the following abnormal
    laboratory results:
    ● Aspartate transaminase (AST) or alanine transaminase (ALT) >1.5x the upper
    limit of normal (ULN).
    ● Serum total bilirubin ³ 1.5 mg/dL (³26 micromol/L).
    ● Creatinine > 1.5 mg/dL (133 micromol/L) in subjects < 65 years old and > upper
    limit of normal range in subjects ³ 65.
    ● Evidence of chronic Hepatitis B or C serology indicative of previous or current
    15) Subject is considered by the Investigator, for any reason, to be an unsuitable
    candidate for the study.
    16) Subjects with any prior exposure to Tysabri (natalizumab).
    17) Subjects with known hypersensitivity to the excipients of adalimumab as stated
    in the label.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of RA patients in clinical remission whom is possible to discontinue adalimumab without an increase in disease activity at 28 weeks.

    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    discontinuation of treatment
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Randomized phase followed by observational period (follow-up visit 104-156 weeks after inclusion).
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Continuation of Adalimumab treatment
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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 state50
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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 Decision2008-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-19
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