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    The EU Clinical Trials Register currently displays   41198   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2011-002896-40
    Sponsor's Protocol Code Number:B3281001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-002896-40
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    REFLECTIONS B328-01
    A.4.1Sponsor's protocol code numberB3281001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01526057
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017 US
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    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 nameRituximab-Pfizer
    D.3.2Product code PF-05280586
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Applicable
    D.3.9.2Current sponsor codePF-05280586
    D.3.9.3Other descriptive nameNot Applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 typeBiosimilar medicinal product
    D.IMP: 2
    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 MabThera®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive nameNot Applicable
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 Rituxan®
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech, Inc. (A Member of the Roche Group)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive nameNot Applicable
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    RHEUMATOID ARTHRITIS
    E.1.1.1Medical condition in easily understood language
    RHEUMATOID ARTHRITIS
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the PK similarity of rituximab Pfizer, rituximab EU and rituximab-US in subjects with active rheumatoid arthritis on a background of methotrexate who have had an inadequate response to 1 or more TNF antagonist therapies.
    E.2.2Secondary objectives of the trial
    • To utilize population PK/PD modeling approaches to integrate PK and PD data for the purpose of detecting potential differences in PK/PD profiles among rituximab-Pfizer, rituximab-EU and rituximab-US.
    • To assess additional clinical response endpoints of rituximab Pfizer, rituximab EU and rituximab-US.
    • To evaluate the overall safety, tolerability and immunogenicity of rituximab-Pfizer, rituximab-EU and rituximab-US.
    • To evaluate health outcomes using HAQ DI in subjects receiving rituximab-Pfizer, rituximab-EU, and rituximab-US.
    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 study:
    1. Age 18 years or older.
    2. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    4. Confirmed diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.
    5. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
    6. RA seropositivity as documented by a screening assessment for RF, and/or anti CCP.
    7. Active disease as defined by:
    a. ≥6 tender/painful joints (of 68 assessed) at screening and baseline, and
    b. ≥6 swollen joints (of 66 assessed) at screening and baseline, and
    c. hs-CRP > ULN at screening, performed by central laboratory
    OR
    Patient’s Global Assessment of Arthritis score ≥50, and
    d. Screening DAS28-CRP >3.2.
    8. Stable dose of oral or parenteral methotrexate 10-25 mg per week (depending on local practice and standard of care; in the case of prior poor tolerance, methotrexate doses as low as 7.5 mg per week are allowed). Subjects must have received methotrexate for at least 3 months, and with a stable dose for at least 4 weeks prior to first dose of study drug.
    9. Inadequate response in the opinion of the investigator to 1 or more approved TNF antagonist therapies administered in accordance with local product label. Inadequate response is defined as:
    a. Failure to achieve adequate clinical response during prior TNF antagonist therapy, or
    b. Relapse following clinical response to TNF antagonist therapy, or
    c. Adverse event to TNF antagonist therapy resulting in discontinuation from treatment.
    Please refer to the Protocol for a full list of Inclusion Criteria
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Any prior treatment with lymphocyte depleting therapies such as, but not limited to rituximab [Rituxan®, MabThera®], alemtuzumab (Campath®), total lymphoid irradiation.
    2. Pregnant females; breast feeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 12 months after last dose of investigational product. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    3. Inadequate bone marrow, liver, renal and immune system functions at screening visit as defined by:
    a. Absolute neutrophil count (ANC) ≤1500 cells/mm^3.
    b. Platelets <100 x 109/L.
    c. Hemoglobin (Hgb) <8 g/dL.
    d. Bilirubin ≥1.5 times the upper limit of normal (x ULN), unless a diagnosis of Gilbert’s Disease in which case ≥2.5 x ULN.
    e. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥3 x ULN.
    f. Serum creatinine ≥1.5 mg/dL.
    g. Immunoglobulin G (IgG) or IgM < lower limit of normal (LLN).
    4. Evidence of untreated or inadequately treated latent, or inadequately treated or active infection with tuberculosis (TB) as defined by one or more of the following:
    a. Screening TB according to local health authority guidance.
    b. History of active TB infection.
    • A Mantoux Purified Protein Derivative (PPD) test may be performed locally for subjects not having prior Bacille Calmette Guérin (BCG) vaccination and interpreted by the investigator according to local standards or country-specific guidelines. A QuantiFERON Gold®™ test is recommended and provided for subjects in this study with a history of BCG vaccination.
    • Screening chest radiograph suggestive of active TB infection.
    c. Untreated or inadequately treated latent TB infection. Subjects previously treated for potential latent TB must have completed a full course of treatment in accordance with local guidelines. Subjects may be randomized after receiving at least the first 1-month of course of the anticipated prophylactic treatment that must be continued to completion.
    5. Known or screen test positive for any of the following viruses or indicators of viral infection:
    a. Known positive for human immunodeficiency virus (HIV).
    b. Test positive for hepatitis B surface antigen (HBsAg). c. Test positive for core antibody associated with positive HBV DNA.
    d. Test positive for hepatitis C virus.
    e. History of disseminated or recurrent herpes zoster (single, limited episode in the past is not exclusionary).
    f. History of disseminated herpes simplex.
    6. Primary or secondary immunodeficiency.
    7. History of recurrent inflammatory joint disease other than rheumatoid arthritis (eg, other autoimmune diseases, vasculopathies, spondyloarthropathies, severe osteoarthritis, post infectious arthritis, gout).
    8. History of lymphoproliferative disorder (eg, Epstein Barr Virus (EBV) related lymphoproliferative disorder, lymphoma, leukemia).
    9. Infection requiring hospitalization, parenteral antimicrobial therapy, or judged clinically significant by the investigator within 3 months prior to first dose of study drug.
    10. Vaccination with live or attenuated vaccines within 6 weeks prior to the first dose of study drug or plan/need to administer these vaccines during study participation or within 4 weeks following discontinuation of study drug.
    11. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, metabolic, pulmonary (eg, uncontrolled COPD), severe cardiac (including heart failure:New York Heart Association Class IV) and neurological diseases, or addiction or dependence on non prescribed substances.
    12. History of a malignancy except for non-melanoma skin cancer (removed prior to entry), in situ carcinoma, or those having non hematological tumors treated with curative intent with no evidence of disease for 5 years.
    13. Significant trauma or surgical procedure within 4 weeks prior to first dose of study drug.
    14. Requirement for treatment during study with prohibited concomitant medications.
    15. History of corticosteroid induced psychosis or significant hyperglycemia.
    16. Participation in other therapeutic studies within at least 4 weeks or 5 half lives, whichever is longer, prior to first dose of study drug.
    17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

    Please refer to the Protocol for a full list of Exclusion Criteria.
    E.5 End points
    E.5.1Primary end point(s)
    PK parameters Cmax, and AUC0-∞
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK parameters Cmax, and AUC0-∞. Timepoint: The parameters will be assessed after Day 85 for the primary endpoint.
    E.5.2Secondary end point(s)
    • PK parameters AUC0-2wk, AUC0-8wk and AUC0-12wk.
    • PD parameters of drug effect including CD19+ B-cell count, circulating IgM and kinetics of early clinical response using DAS28-CRP.
    • Type, incidence, severity, timing, seriousness, and relatedness of adverse events, and laboratory abnormalities.
    • Incidence of anti rituximab antibodies (ADA), including neutralizing antibodies (Nab), and safety associated with immune response.
    • Mean change from baseline in DAS28-CRP, EULAR response (reduction ≥1.2), LDAS (≤3.2), and DAS remission (<2.6).
    • ACR response at End of Treatment (EOT).
    • Outcome measure using HAQ DI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK parameters: AUC0-2wk Day 15: AUC0-8wk Day 57: AUC0-12wk Day 85
    PD parameters: CD19+ B-cell count and IgM Day 1, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169 and follow-up as needed every 3 months DAS28-CRP Day 15, 29, 57 and 85
    • Type, incidence, severity, timing, seriousness, and relatedness of adverse events, and laboratory abnormalities throughout the study
    • Incidence of anti drug antibodies and safety associated with immune response Day 1, 15, 29, 57, 85 and 169 with follow-up every 3 months if needed.
    • Mean change from baseline in DAS28-CRP, EULAR response, LDAS, and DAS remission Day 15, 29, 57, 85, 113, 141 and 169.
    • ACR response Day 169.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Tolerability and immunogenicity
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Colombia
    France
    Germany
    Israel
    Italy
    Mexico
    Peru
    Poland
    Russian Federation
    South Africa
    Spain
    Taiwan
    United Kingdom
    United States
    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
    As per protocol
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 147
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 195
    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)
    As per protocol.
    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 Decision2012-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-07
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