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    Summary
    EudraCT Number:2007-001420-12
    Sponsor's Protocol Code Number:D1520C00001
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-18
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2007-001420-12
    A.3Full title of the trial
    A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine
    A.4.1Sponsor's protocol code numberD1520C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 nameAZD9056 hydrochloride
    D.3.2Product code AZD9056
    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 codeAZD9056
    D.3.9.3Other descriptive nameNone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.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 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 nameAZD9056 hydrochloride
    D.3.2Product code AZD9056
    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 codeAZD9056
    D.3.9.3Other descriptive nameNone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa 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 nameEnbrel
    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 INNEtanercept
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeEnbrel is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
    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
    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
    The primary objective of the study is to evaluate the dose response relationship across 4 doses of AZD9056 (50, 100, 200 and 400 mg) on signs and symptoms of rheumatoid arthritis (RA), as measured by the proportion of patients meeting the American College of Rheumatology 20% response criteria (ACR20) at 6 months.
    E.2.2Secondary objectives of the trial
    (1) To evaluate the dose response relationship across 4 doses of AZD9056 on signs and symptoms and disease activity of RA
    (2) To investigate AZD9056 population pharmacokinetics in plasma in patients with RA
    (3) To evaluate the safety and tolerability of AZD9056
    (4) To provide information on the effects of AZD9056 on the quality of life measured by Short-Form-36 (SF-36) and Rheumatoid Arthritis Quality of Life (RAQoL) Questionnaire
    (5) To investigate radiological changes using standard X-ray (using the Sharp score as modified according to the method of van der Heijde).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent
    2. Male or female, aged 18 years or over
    3. Females must be using 2 forms of contraception for the duration of the study and 4 weeks after the last dose of study medication, unless they are surgically sterile or post-menopausal. Males who are involved in the study must agree to abstain from procreative sex during the study and for 12 weeks after the last dose of study medication
    4. Diagnosis of RA after the age of 16 according to the revised (1987) criteria of the American College of Rheumatology
    5. Have active RA defined as: ≥4 swollen joints and ≥6 tender/painful joints (from 28 joint count) and either:
    - ESR ≥28 mm/h
    - CRP ≥10 mg/L.
    6. At least one of the following:
    - Documented history of positive rheumatoid factor
    - Current presence of rheumatoid factor
    - Baseline radiographic erosion
    - Presence of serum anti-CCP antibodies.
    7. Be receiving one of the following treatments:
    - Oral, subcutaneous or intramuscular methotrexate for at least 6 months prior to randomisation.
    - Oral sulphasalazine for at least 16 weeks prior to randomisation.
    8. Haemoglobin at Visit 1 either:
    − within the normal range, or
    − below the normal range but not less than 9 g/dl and only if normochromic and
    normocytic with no clinical or laboratory signs of chronic blood loss.
    9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
    ≤1.2 x upper limit of normal (ULN) at Visit 1; bilirubin equal to or below the upper limit of normal at Visit 1.
    E.4Principal exclusion criteria
    1. Pregnant or lactating females
    2. Any systemic inflammatory condition in addition to RA that may interfere with the interpretation of the outcome data (examples include but are not limited to polymyalgia rheumatica, giant cell [including temporal] arteritis, reactive arthritis)
    3. Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes
    4. American College of Rheumatology functional class IV or wheelchair/bed-bound
    5. Persistently abnormal liver function enzymes defined as AST/ALT >2 x ULN on more than one occasion in the past 6 months; or any pattern of liver function test abnormality in the previous 6 months requiring specific investigation
    6. Treatment with any of the following:
    - Leflunomide, cyclosporine, azathioprine or hydroxychloroquine within 28 days of randomisation. Note: Any patient that has received leflunomide less than 3 months but more than 4 weeks before randomisation must have completed a cholestyramine washout prior to study entry
    - Biological agents and anti-TNF agents within 56 days (with the exception of rituximab, which must not have been used within 12 months) of randomisation
    - Gold within 12 months of randomisation.
    7. Any prior treatment with etanercept
    8. Patients for whom etanercept is inappropriate including:
    - Hypersensitivity to the active substance or to any of the excipients
    - Sepsis or risk of sepsis
    - Patients with active infections (including chronic or localised infections)
    - Patients being treated with anakinra.
    Note: Physicians should exercise caution in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections (such as advanced or poorly controlled diabetes).
    - Patients who have received live vaccine in the 4 weeks prior to randomisation
    - Patients who have a previous history of blood dyscrasias
    - Patients with pre-existing or recent onset of CNS demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease
    - Patients who have congestive heart failure
    - Patients with Wegener's Granulomatosis.
    9. Patients with a history of active tuberculosis or who have a positive tuberculin skin test or chest X-ray findings suggestive of active or healed tuberculosis (other than calcified foci alone).
    10. Intramuscular or intravenous steroid injection or intra-articular steroid injection within 6 weeks of randomisation
    11. Patients receiving any of the following:
    - Lovastatin
    - Doses of simvastatin and atorvastatin >20 mg per day
    - Moderate to strong CYP3A4 inhibitors/substrates
    12. Patients receiving digoxin or cisapride
    13. Patients with known Human Immunodeficiency Virus (HIV) or belong to a high risk group for HIV infection
    14. Evidence of serum hepatitis or presence of hepatitis B surface antigen or hepatitis C antibodies
    15. History of malignancy or neoplastic disease, except successfully treated basal or squamous cell carcinoma of the skin
    16. Chronic liver (also consider inclusion criterion 9 and exclusion criterion 5) or renal disease (subjects may be included if the plasma/serum creatinine is within the normal range or if abnormal the calculated (using Cockroft-Gault) or measured glomerular filtration rate (GFR) must be > 50 mL/min
    17. Patients with current active peptic ulceration or a history of peptic ulcer disease in the previous 5 years
    18. Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study
    19. History of retinopathy (age-related changes are permitted at the discretion of the investigator)
    20. Clinically significant ECG abnormality (including abnormal QT/QTc interval, eg QTc >450 mm/sec according to Bazett’s formula) suggestive of underlying cardiovascular disease, which in the opinion of the investigator should preclude participation in the study.
    21. Recent participation in a clinical study involving an investigational compound within 5 half-lives of the investigational product or 3 months prior to randomisation (whichever is longer). Patients involved in non-drug methodology studies (either invasive or non-invasive) may be included without delay, at the discretion of the investigator
    22. Major surgery or significant other trauma in the 3 months prior to randomisation or expected surgery within 9 months of randomisation
    23. History of excessive alcohol consumption or chronic alcohol induced disease
    24. Patients who in the opinion of the investigator should not participate in the study
    25. Previous enrolment or randomisation of treatment in the present study
    26. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study centre).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable of this trial is the proportion of treated patients who achieve ACR20 at Visit 8.
    The proportion of patients who achieved ACR20 will be computed at Visits 3 to 9. Visit 8 (computed on the full analysis set) will be regarded as the primary endpoint.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open comparator arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Open comparator arm
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Yes
    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 database lock, which is the timepoint after which no patient will be exposed to study related activities. This definition is used to ensure consistency with trials conducted outside the EU.
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 360
    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)
    Following completion of the study, patients will revert to the normal standard of care for treatment of RA, in line with local treatment guidelines.
    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 Decision2007-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
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