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    Summary
    EudraCT Number:2012-003223-38
    Sponsor's Protocol Code Number:B3281004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-003223-38
    A.3Full title of the trial
    EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS
    ESTUDIO DE EXTENSIÓN PARA EVALUAR EL TRATAMIENTO CON PF-05280586 EN COMPARACIÓN CON RITUXIMAB EN SUJETOS CON ARTRITIS REUMATOIDE ACTIVA QUE HAN PARTICIPADO EN OTROS ENSAYOS CLÍNICOS CON PF-05280586
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.
    Estudio de extensión en Artritis Reumatoide para pacientes que han participado en otros ensayos con PF-05280586.
    A.3.2Name or abbreviated title of the trial where available
    REFLECTIONS B328-04
    A.4.1Sponsor's protocol code numberB3281004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01643928
    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
    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
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    RHEUMATOID ARTHRITIS
    Artritis reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab-Pfizer program.

    To evaluate the overall safety, tolerability and immunogenicity of rituximab-Pfizer occurring after transition from a licensed rituximab product to rituximab-Pfizer.

    To continue follow-up of biomarker and efficacy endpoints of interest in previous studies in the rituximab-Pfizer program contributing to this protocol.
    Proporcionar un acceso continuo al tratamiento a los sujetos con artritis reumatoide activa que hayan participado durante al menos 16 semanas en otros estudios del programa de rituximab-Pfizer.

    Evaluar la seguridad, tolerancia e inmunogenicidad general de rituximab-Pfizer después de pasar del producto de rituximab comercialmente autorizado a rituximab-Pfizer.

    Continuar el seguimiento del biomarcador y los criterios de valoración de la eficacia de interés procedentes de estudios anteriores del programa de rituximab-Pfizer que contribuyen a este protocolo.
    E.2.2Secondary objectives of the trial
    Not applicable
    No Aplica
    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. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    2. Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.
    3. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 12 months after the last dose of assigned treatment. 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.
    4. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
    Los sujetos deben cumplir todos los criterios de inclusión siguientes para poder participar en el estudio:

    1.Sujetos que estén dispuestos y sean capaces de cumplir con las visitas programadas, el plan de tratamiento, los análisis de laboratorio y otros procedimientos del estudio.

    2.Haber participado durante un mínimo de 16 semanas después de iniciar el último ciclo de tratamiento en un estudio anterior de artritis reumatoide del programa de rituximab-Pfizer en los últimos 2 meses.

    3.Las mujeres y hombres en edad fértil deben acceder a utilizar un método anticonceptivo altamente eficaz a lo largo del estudio y durante, al menos, 12 meses después de la última dosis del tratamiento asignado. Un sujeto está en edad fértil si, a criterio del investigador, tiene la capacidad biológica de concebir hijos y es sexualmente activo.

    4.Comprobante de un documento de consentimiento informado, firmado y fechado personalmente, que indique que el sujeto ha sido informado de todos los aspectos pertinentes del ensayo.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
    2. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for 12 months after last dose of investigational product. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
    3. Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
    4. Requirement for treatment during study with prohibited concomitant medications listed in Appendix 1.
    5. Severe reaction to licensed rituximab product or rituximab-Pfizer (eg, anaphylaxis).
    6. Serious adverse event that was assessed as related to study drug in the prior study.
    7. Absolute neutrophil count (ANC) ? 1500 cells/mm^3. ANC may be repeated one time to establish eligibility.
    8. IgG levels <300 mg/dL. IgG may be repeated one time to establish eligibility.
    9. 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.
    Los sujetos que presenten cualquiera de los siguientes aspectos no podrán ser incluidos en el estudio:

    1.Sujetos que sean miembros del personal del centro de investigación o parientes de dichos miembros del personal del centro o sujetos que sean empleados de Pfizer involucrados directamente en la realización del estudio.
    2.Mujeres embarazadas; mujeres en periodo de lactancia; mujeres y hombres en edad fértil que no utilicen un anticonceptivo de eficacia elevada o que no accedan a seguir utilizando un anticonceptivo altamente eficaz durante los 12 meses posteriores a la última dosis del producto en investigación. Las mujeres en edad fértil deben presentar una prueba de embarazo negativa antes de la inclusión en este estudio.
    3.Haber iniciado un tratamiento con agentes en investigación u otros agentes biológicos (incluidos Rituxan y MabThera) desde su participación en un estudio anterior de artritis reumatoide en el programa de rituximab-Pfizer.
    4.Necesidad de un tratamiento durante el estudio con medicamentos concomitantes prohibidos enumerados en el Apéndice 1.
    5.Reacción grave al producto comercializado de rituximab o rituximab-Pfizer (por ejemplo, anafilaxia).
    6.Acontecimiento adverso grave que se valoró como relacionado con el fármaco del estudio en el estudio anterior.
    7.Recuento absoluto de neutrófilos (RAN) ?1.500 células/mm3. El RAN puede repetirse una vez para establecer la idoneidad.
    8.Niveles de IgG <300 mg/dl. La IgG puede repetirse una vez para establecer la idoneidad.
    9.Otros trastornos graves psiquiátricos o médicos, agudos o crónicos, u otras anomalías de laboratorio que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o que puedan interferir en la interpretación de los resultados del estudio y, a criterio del investigador, hicieran que el sujeto no fuese adecuado para la inclusión en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ? Type, incidence, severity, timing, seriousness and relatedness of adverse events and
    laboratory abnormalities including those occurring after transition from a licensed
    rituximab product to rituximab-Pfizer.
    ? Incidence of anti-drug antibodies (ADA), including neutralizing antibodies, and drug concentrations.
    ? CD19+ B-cell count.
    ? Serum biomarkers IgG, IgM, RF, anti-CCP and complement.
    ? Mean change from initial study baseline in DAS28-CRP, EULAR response, LDAS (? 3.2), and DAS-CRP remission (<2.6).
    ? ACR response, calculated from initial study baseline.
    ? Change from initial study baseline in individual components of ACR response.
    ? Outcome measure using HAQ-DI.
    ?Tipo, incidencia, intensidad, momento, gravedad y relación de los acontecimientos adversos y de las anomalías de laboratorio, incluyendo las que tengan lugar después del paso del producto de rituximab comercialmente autorizado a rituximab-Pfizer.
    ?Incidencia de los anticuerpos contra el fármaco (ADA, por sus siglas en inglés), incluyendo anticuerpos neutralizantes y concentraciones de fármacos.
    ?Recuento de los linfocitos B CD19+.
    ?Biomarcadores séricos IgG, IgM, FR, anti-PCC y complemento.
    ?Cambio medio desde el inicio del estudio en la DAS28-CRP, la respuesta EULAR, la LDAS (?3,2) y la remisión de la DAS-CRP (<2,6).
    ?Respuesta según el ACR, calculada desde el inicio del estudio.
    ?Cambio desde el inicio del estudio en los componentes individuales de la respuesta del ACR.
    ?Medida del resultado utilizando el HAQ-DI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? Documentation of AEs - Each clinic visit, including follow-up.
    ? ADA and Drug Concentrations - Each course: Days 1, 15 ± 3, 85 ± 7 and 169 ± 7. Follow-up: every 3 months.
    ? CD19+ B-cell count - Each course: Days 1, 36 ± 7, 85 ± 7 and 169 ± 7 (except no Day 36 in 3rd course) and every 3 months during follow-up.
    ? Serum IgG, IgM - Screening (Days -28 to -1), Each course: Days 1, 169 ± 7 (except no Day 1 in 1st course).
    ? RF, anti-CCP and complement - Each course: Days 1 and 169 ± 7.
    ? HAQ-DI, DAS28-CRP and ACR response ? Each course: Days 1, 36 ± 7, 85 ± 7 and 169 ± 7 (except no Day 36 in 3rd course).
    -Documentación de los AAS-cada visita clínica, incluido seguimiento.
    - ADA y concentraciones de medicación - cada curso: días 1, 15 ± 3, 85 ± 7 y 169 ± 7. Seguimiento: cada 3 meses.
    - CD19+ recuento de células B - cada curso: días 1, 36 ± 7, 85 ± 7 y 169 ± 7 (Excepto día 36 en 3er curso) y cada 3 meses durante el seguimiento.
    IgG, IgM en suero - screening (días -28 a -1), cada curso: Días 1, 169 ± 7 (excepto día 1 en 1er curso).
    ? RF, anti-CCP y complemento - Cada curso: Días 1 y 169 ± 7.
    ? HAQ-DI, DAS28-CRP y respuesta ACR ? Cada curso: Días 1, 36 ± 7, 85 ± 7 y 169 ± 7 (excepto Día 36 en 3er curso).
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 No
    E.6.7Pharmacodynamic No
    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
    Immunogenicity:
    - of treatment with rituximab-Pfizer
    - after transitioning from Rituxan or MabThera to rituximab-Pfizer
    Inmunogenicidad:
    - del tratamiento con rituximab-Pfizer
    - después de la transición de Rituxan o MabThera a rituximab-Pfizer
    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
    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
    Según protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 38
    F.4.2.2In the whole clinical trial 157
    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)
    Study drugs and the study defined medical care will only be given to the subjects during the study. In the event that the subjects experience adverse events (AEs) which require follow-up, appropriate medical care will be provided.

    As per protocol, for AEs (serious/non-serious) with a causal relationship to the study drug, follow-up by the investigator is required until the event/sequelae resolve or stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.
    Medicación y cuidado médico definidos para el estudio se proporcionaran únicamente durante la participación en el mismo. En caso de experimentar acontecimientos adversos (AAs) que requieran seguimiento, se proporcionará cuidado médico adecuado.
    Por protocolo, para AAs con relación causal con la medicación del estudio, se requiere seguimiento hasta resolución o estabilización del acontecimiento/secuela a un nivel adecuado para el investigador, y Pfizer coincida con dicha evaluación
    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 Decision2013-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
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