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    Summary
    EudraCT Number:2007-001035-58
    Sponsor's Protocol Code Number:A4001056
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-16
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2007-001035-58
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA4001056
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorPfizer Inc, 235 East 42nd Street,New York, NY 10017
    B.1.3.4CountryUnited States
    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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNMaraviroc
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK-427,857
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    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 objectives of this study are:

    1. To evaluate the safety and tolerability of maraviroc at 150 and 300 mg BID
    administered for 4 weeks to subjects in combination with Methotrexate(MTX);

    2. To characterize the PK and to investigate potential drug-drug interactions (DDIs)
    between maraviroc and MTX in a cohort of subjects (n = 16);

    3. To assess the efficacy of maraviroc (either 150 or 300 mg versus placebo; both
    administered BID for 12 weeks) in subjects with RA receiving MTX.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of maraviroc treatment on patient reported outcomes and disease activity status.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

    1. Must be legal age of consent;

    2. Must have active RA based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria) and a current level of disease activity defined as:
    • ≥6 tender/painful joints on motion (28 joint count) – Waived for entry into the
    Safety/PK Component
    • ≥6 swollen joints (28 joint count) – Waived for entry into the Safety/PK Component
    • CRP ≥0.8 mg/dL (8 mg/L) or an erythrocyte sedimentation rate (ESR) of at least
    28 mm/hour – Waived for entry into the Safety/PK Component.

    3. Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II,
    or III ;

    4. Must be receiving MTX treatment that satisfies all of the following:
    • ≥10 mg/week and ≤25 mg/week (oral or parenteral) unless documented intolerance
    requires a lower dose;
    • ≥12 weeks duration of prior therapy;
    • MTX dose has been stable ≥4 weeks prior to entry and will remain unchanged
    throughout the 12-week Treatment Period.

    5. Must provide written informed consent and be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:

    1. Subjects with a diagnosis of:
    • any other inflammatory arthritis (eg, spondyloarthropathies); or
    • a secondary, non-inflammatory arthritis (eg, osteoarthritis, fibromyalgia) that may
    interfere with disease activity assessments.

    2. Subjects who have received the following prior treatments:
    • Within prior 4 weeks: Auranofin (oral gold), injectable gold (aurothioglucose or
    aurothiomalate), sulfasalazine, d-penicillamine, antimalarials* (chloroquine and
    hydroxychloroquine); azathioprine, cyclosporine, intra-articular, peri-articular,
    intramuscular or intravenous corticosteroids, anakrina (Kineret®), etanercept
    (Enbrel®), herbal supplements including fish oil, or leflunomide; (*POC Component only:subjects on stable doses of antimalarials (chloroquine and hydroxychlorquine) for at least 60 days may continue these medications).
    • Within prior 8 weeks: Infliximab (Remicade®), adalimumab (Humira®).
    • Within prior 8 weeks: Any experimental therapy for RA (within or outside a clinical
    trial); with the exception of experimental NSAID/COX-2 inhibitors for which a
    washout interval of not less than 5 half-lives shall apply.
    • Within prior 3 months: abatacept (Orencia®).
    • Within prior 12 months: rituximab (Rixutan®).

    3. Subjects with a history of:
    • chronic or recent serious or life-threatening infection; severe, progressive, and/or
    uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
    cardiac, neurological disease within 12 weeks of first dose;
    • tuberculosis without treatment and/or positive tuberculin reaction without known
    vaccination with the bacilli Calmette-Guerin vaccine (BCG).
    • significant trauma or major surgery within 8 weeks of first dose of study medication;
    • alcohol abuse with less than 24 weeks of sobriety; drug abuse within 3 years of study start.

    4. Subjects who present with:
    • a positive CCR5∆32 mutation – Waived for entry into the Safety/PK Component;
    • a history of postural hypotension or a screen finding of postural hypotension (with or without symptoms) defined as either a systolic BP drop >20 mm Hg, or diastolic BP
    drop >10 mm Hg and/or drop in systolic BP to <90 mm Hg
    • any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically
    significant diabetic gastroenteropathy);
    • New York Heart Association (NYHA) Class III-IV congestive heart failure requiring
    treatment;
    • Mean QTc interval >450 msec;
    • infection with HIV or Hepatitis B or C, or evidence of any current active infection;
    • a history of cancer and in remission for <3 years excluding subjects with adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

    5. Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments:
    • hemoglobin <10 gm/dL, hematocrit <32%
    • absolute white blood cell (WBC) count <3.0 × 109/L (<3000/mm3)
    • platelet count <100 × 109/L (<100,000/mm3)
    • AST (serum glutamic-oxaloacetic transaminase [SGOT]) or ALT (serum glutamate
    pyruvate transaminase [SGPT]) >1.2 × ULN
    • total bilirubin >1.2 X ULN
    • albumin <3.5 g/dL or 35 g/L due to known liver disease
    • estimated glomerular filtration rate (GFR) ≤60 mL/min based on Cockcroft-Gault
    calculation
    • significantly abnormal electrocardiogram (ECG) findings

    6. If taking a NSAID, COX-2 inhibitor, oral corticosteroids (≤10 mg prednisone or
    equivalent per day), or opioid (≤30 mg oral morphine or equivalent per day) doses must be stable throughout the screening and study treatment periods.

    7. Subjects (males or females) having reproductive potential that are unwilling to use an adequate method of birth control for the duration of study drug treatment and 1 month following last dosing day; also subjects who are pregnant or breastfeeding.

    8. Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the American College of Rheumatology 20% (ACR 20) response rate 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 Yes
    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 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) 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.8.4.1Number 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 EEA13
    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 months5
    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 months5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-08-16. Yes
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 114
    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 Decision2007-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-02
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