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    Summary
    EudraCT Number:2006-003054-26
    Sponsor's Protocol Code Number:TAK-783/EC201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-12-14
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-003054-26
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberTAK-783/EC201
    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 SponsorTakeda Global R&D (Europe) Ltd
    B.1.3.4CountryUnited Kingdom
    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.3.2Product code TAK-783
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTAK-783
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number90 to 110
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid arthritis (RA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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 evaluate the efficacy by ACR20 response rates of TAK-783 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis over 12 weeks in subjects with a partial response to methotrexate.
    - To evaluate the safety of the combination of TAK-783 in combination with methotrexate versus placebo plus methotrexate over 16 weeks.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy by ACR20 response rates of TAK-783 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis over 12 weeks in subjects with a partial response to methotrexate.
    - To evaluate the safety of TAK-783 in combination with methotrexate versus placebo plus methotrexate over 12 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women, who are capable of understanding and willing to sign the informed consent, are 18 years or older, with a diagnosis of rheumatoid arthritis for at least 6 months and less than 3 years, with partial response to methotrexate are to be included in this study. Subjects must have active rheumatoid arthritis using American College of Rheumatology (ACR) criteria (defined as 6 swollen joints and 9 tender joints, and a CRP 1.2 mg/dL or ESR 28 mm/hr) despite methotrexate therapy. All subjects must have been treated with methotrexate for at least 6 months and have been on a stable dose for at least 8 weeks prior to the Baseline Visit. Subjects on non-steroidal anti-inflammatory drugs (NSAIDs) must remain on a stable dose of their NSAIDs (throughout the study) and subjects on prednisone (or its equivalent) must remain on a stable maintenance dose (throughout the study) not to exceed 10 mg/day. Subjects must have a normal chest X-ray within 3 months of the pre-treatment period. Subjects must have a negative (< 5mm) purified protein derivative (PPD) skin test for tuberculosis (TB) and a negative TB screening history.
    E.4Principal exclusion criteria
    Subjects who have hypersensitivity to TAK-783 or its constituents, with a significant history of uncontrolled hypertension, secondary, non-inflammatory type of arthritis, severe liver disease, or any significant results from physical exams, electrocardiograms (ECGs), or clinical laboratory and diagnostic screening tests as determined by the investigator. The subject has failed therapy due to lack of efficacy with more than 2 disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate.
    Excluded medication are:
    • All DMARDs and biologics other than methotrexate used to treat rheumatoid arthritis (including tetracycline when used as a DMARD).
    • Tetracyclines cannot be used for any reason during the study.
    • All systemic (non-DMARD) immunosuppressants with the exception of prednisone or its equivalent.
    • Controlled-release oxycodone (OxyContin) and other non-NSAID long-acting analgesics.
    • Aspirin and aspirin-containing combination products used for analgesia. (Aspirin <325 mg/day for cardiac prophylaxis is permitted.)
    • Intra- or peri-articular joint injections are not allowed during the study.
    • Any investigational drugs within 30 days prior to randomization and throughout the trial.

    f) The subject has uncontrolled hypertension.
    g) The subject has moderate or severe liver disease, as defined by one or more of the following at the Screening Visit:
    i. Aspartate or alanine transaminase (AST or ALT) greater than 1.2 times ULN.
    ii. Total bilirubin greater than 1.2 times ULN (excluding subject’s diagnosed with Gilbert’s Disease).
    iii. Alkaline phosphatase greater than 1.5 times ULN.
    h) The subject has elevated serum creatinine level for age and gender at the Screening Visit.
    i) The subject has hemoglobin less than 9.0 mg/dL, white blood cell count of less than 3000/mm3 or a platelet count less than 100,000/mm3 at the Screening Visit.
    j) The subject has an ACR revised rheumatoid arthritis functional status of IV at the Screening Visit.
    k) The subject has used a disease-modifying antirheumatic drug (DMARD) or a biologic agent other than methotrexate (including sulfasalazine, tetracycline, leflunomide [AravaÒ] infliximab [RemicadeÒ], leflunomide [AravaÒ], etanercept [EnbrelÒ], adalimumab (HumiraÒ), or anakinra [KineretÒ]) in the 12 weeks prior to the Baseline Visit.
    l) The subject has used plaquenil in the 6 months prior to the Baseline Visit.
    m) The subject has ever received abatacept (OrenciaÒ) or rituximab (RituxanÒ).
    n) The subject has failed due to lack of efficacy with more than 2 DMARDs (other than methotrexate).
    o) The subject has received any intra-articular, intramuscular, or intravenous corticosteroids within 4 weeks prior to the Baseline Visit.
    p) The subject has had any previous use of cyclophosphamide, chlorambucil, or other alkylating agent.
    q) The subject is at high risk of an opportunistic infection because of a compromised immune system, in the investigator’s opinion, with the exception of subjects receiving chronic steroid treatment.
    r) The subject has a history of, or a current inflammatory condition with signs and symptoms that might confound the diagnosis of rheumatoid arthritis (eg, connective tissue disease, systemic lupus erythematosis, psoriasis, psoriatic arthritis, spondyloarthropathy).
    s) The subject has been diagnosed as having a secondary, non-inflammatory type of arthritis (eg, osteoarthritis [OA] or fibromyalgia) that, in the investigator’s opinion, is symptomatic enough to interfere with the evaluation of the efficacy of the study medications on the subject’s primary diagnosis of rheumatoid arthritis.
    t) The subject has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic beverages per day) within the past 2 years.
    u) The subject has a BMI greater than 35 at Screening.
    v) The subject has a previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug. NOTE: This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma.
    w) The subject is unwilling or unable to comply with the protocol, scheduled appointments or medications, or has little or no ability for self-care.
    x) The subject has received any investigational compound within 30 days prior to the Baseline Visit.
    y) The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee, involved in conduct of this study.
    z) The subject has donated more than 400 mL of blood within the 90 days prior to the Baseline Visit.
    aa) The subject is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
    bb) The subject has a known hypersensitivity to TAK 783 or its constituents.
    E.5 End points
    E.5.1Primary end point(s)
    Composite ACR20 response rates 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 No
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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.8.4.1Number 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 EEA30
    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
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 state45
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 230
    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 Decision2008-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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