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    Summary
    EudraCT Number:2006-002216-10
    Sponsor's Protocol Code Number:2006012
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-02
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-002216-10
    A.3Full title of the trial
    A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate
    A.3.2Name or abbreviated title of the trial where available
    RACER
    A.4.1Sponsor's protocol code number2006012
    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 SponsorProcter & Gamble Pharmaceuticals
    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.3.1Product namePG-760564
    D.3.2Product code PG-760564
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule*
    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 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 assess the effect of PG 760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 weeks
    E.2.2Secondary objectives of the trial
    - To assess the effect of PG 760564 on the proportion of patients meeting the ACR 50 and ACR 70 responses at 12 weeks;

    - To assess the effect of PG 760564 on the change from baseline in 28 joint Disease Activity Score (DAS 28) at 12 weeks;

    - To assess the effect of PG 760564 on the change from baseline at 12 weeks in the following parameters:
    Tender joint count
    Swollen joint count
    Physician’s global assessment
    Patient’s global assessment
    Patient’s assessment of pain
    Health Assessment Questionnaire (HAQ) score
    Acute phase reactants [erythrocyte sedimentation rate (ESR) and C reactive protein (CRP)]
    TNF-alpha, IL-1, and IL-6
    Duration of morning stiffness
    Rheumatoid factor (RF) titer;

    - To assess the effect of PG-760564 on time to ACR 20.

    - To assess the safety and tolerability of PG 760564 in patients with RA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who meet all of the following criteria are eligible for participation in the study:

    a. Men and women, 18 to 70 years of age, inclusive, at screening;

    b. Who meet ACR criteria for RA, with a documented diagnosis of RA for at least 6 months;

    c. Whose functional capacity is class I, II, or III according to the revised criteria of the ACR (Appendix 6);

    d. Who have active disease despite treatment with MTX before washout of any DMARDs other than MTX. Active disease for this study will be defined as follows:
    - At least 6 swollen joints and 6 tender joints; AND,
    - At least one of the following 3 criteria must be present:
    ESR of at least 28 mm/hour
    Elevated CRP
    Morning stiffness lasting at least 45 minutes;

    d. Who have been treated with MTX for at least 24 weeks. The dose of MTX must be stable for at least 8 weeks, at 15-20 mg/week, or at 10 mg/week if that is the maximal tolerated dose, before starting study medication;

    e. If female, must be (as documented in the patient notes):
    - Post menopausal (at least 1 year without spontaneous menses), or
    - Surgically sterile (if by tubal ligation, must have been performed at least 3 months before entry into the study), or
    - Using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception, intra-uterine device) for at least 3 months prior to randomization and for the duration of the study including the follow-up period, in conjunction with a barrier method (e.g., condom and spermicide, diaphragm and spermicide) for the duration of the study and during the follow-up period;
    NOTE: All contraception precautions for MTX must be followed.

    f. If sexually-active male, must be surgically sterile (e.g., non-reversed vasectomy with confirmed azoospermia) or use condom during the study and during the follow-up period;
    NOTE: All contraception precautions for MTX must be followed.

    g. Who are willing and able to participate in the study and provide signed informed consent.
    E.4Principal exclusion criteria
    - Active or latent tuberculous infection as defined as: history of tuberculosis (TB) OR Chest X ray suggestive of former or current tuberculous infection OR Positive tuberculin skin test with purified protein derivative of tuberculin (PPD) equal to or more than 5 mm in a patient without history of vaccination with bacillus Calmette-Guérin (BCG) OR In Europe, vaccination with BCG and positive PPD equal to or more than 8 mm OR In Europe, vaccination with BCG and positive PPD equal to or more than 5 mm but ≤8 mm and any of the following risk factors: silicosis, residents and employees of high-risk congregate settings, weight loss more than10% of ideal body weight, gastrectomy, jejunoileal bypass
    - Active listeriosis
    - History of episode of infection requiring hospitalization within 30 days before screening or episode of infection requiring IV antibiotics within 30 days before sceening or current active infection
    - History of chronic or recurrent infections, or immunodeficiency
    - Indwelling catheters
    - Bronchiectasis
    - History of uveitis or other inflammatory eye disease
    - Autoimmune diseases other than RA [MCTD, seronegative spondyloarthropathy, SLE, UCTD, psoriatic arthritis, sarcoidosis, etc.], except Sjogren’s syndrome secondary to RA
    - Chronic liver diseases, serologic evidence for infection with hep B or hep C
    - History of alcohol or drug abuse
    - Abnormal hepatic and renal functions; patients with known elevations of transaminases greater than 1.2 times ULN on 2 or more occasions in the 6 months before screening
    - Platelets <100 x 109/L
    - Abnormal WBC and/or significant abnormalities in other complete blood count (CBC) values. Hemoglobin (Hgb) <10 mg/dL
    - Joint surgery within 2 months of screening
    - History of lymphoma, leukemia, or lymphoproliferative disorders
    - History of other malignancies other than treated basal cell carcinoma of the skin
    - History of demyelinating diseases
    - History of heart failure, NYHA class III or IV
    - Pregnant or lactating women, or women who plan to become pregnant
    - Personal or family history of prolonged QT syndromes.
    - Other risk factors for torsade de pointes (TdP)
    - Hypokalemia, hypomagnesemia, or hypocalcemia;
    - Drugs known to cause prolongation of QT interval (must be off for at least 5 half-lives to be enrolled)
    - Demonstrated likelihood not to comply with protocol requirements
    - Current participation in another clinical trial involving active intervention
    - Known allergy to components of the study medication
    - History of efficacy failure with etanercept, infliximab, adalimumab, anakinra, and abatacept
    - History of treatment with B cell depleting therapies and immunoadsorption
    - History of treatment with p-38 MAP kinase inhibitors
    - History of treatment with cyclosporine, cyclophosphamide, or other alkylating agents
    - Other diseases requiring immunosuppressive therapy
    - Treatment with leflunomide within 6 months prior to study entry
    - Intra-articular or intramuscular steroids within 4 weeks before screening
    - Change in NSAID and/or corticosteroid doses within 30 days prior to entry into the study (Day 1 of the washout period)
    - Treatment with any experimental/investigational therapy within the last 2 months for chemical and 6 months (from screening date) for biologic drugs
    - Use of the following inducers of CYP 3A4 (carbamazepine, phenobarbital, phenytoin, St John's Wort and troglitazone) or inhibitors of CYP 3A4 (diltiazem, fluvoxamine, grapefruit juice, itraconazole, ketoconazole, mibefradil, nefazodone, troleandomycin, cimetidine, and verapamil) of CYP 3A4; the washout period for these drugs will be 5 days except for phenobarbital for which it will be 21 days
    - Patients not treated with folic or folinic acid
    Any other conditions, including important concurrent illnesses (e.g., hypothyroidism) that, in the opinion of the Investigator would jeopardize the study.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the effect of PG 760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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.8.5The trial involves multiple Member States Yes
    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
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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 Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 270
    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 Decision2007-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-20
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