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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41189   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) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2007-003623-20
    Sponsor's Protocol Code Number:JCA-RIT-2007-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-02-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-003623-20
    A.3Full title of the trial
    Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).

    Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).
    A.4.1Sponsor's protocol code numberJCA-RIT-2007-01
    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 SponsorDr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 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 AuthorisationSpain
    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
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide.
    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
    El objetivo principal es determinar los cambios celulares y moleculares inducidos por el tratamiento con rituximab en tejido sinovial, predominantemente en los procesos relacionados con la célula B, y su relación con la respuesta clínica en pacientes con artritis reumatoide (AR).
    E.2.2Secondary objectives of the trial
    Establecer correlaciones potenciales entre los cambios de marcadores incluida la linfoneogénesis, y la respuesta clínica, comparando pacientes respondedores y no respondedores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • pacientes de ambos sexos, con edades comprendidas entre 18 y 80 años, diagnosticados de AR según los criterios del American College of Rheumatology (ACR) de 1987.
    • pacientes que estén recibiendo actualmente o que han recibido previamente un tratamiento antagonista del TNF- (Tumor Necrosis Factor; factor de necrosis tumoral) pero que, en opinión del investigador, han mostrado una respuesta insuficiente (DAS≥3,2; Disease Activity Score) a dicho tratamiento o que tengan una respuesta insuficiente al metotrexato a dosis >15 mg por semana durante 3 meses y en los que estén contraindicados los antagonistas del TNF-.
    • pacientes con AR activa (DAS28>3,2) con al menos una rodilla, muñeca o tobillo con sinovitis activa (dolor y derrame sinovial inflamatorio) a la inclusión.
    • pacientes que hayan firmado el consentimiento informado.
    Definición de artritis reumatoide según los criterios ACR:
    Los pacientes deben presentar cuatro o más de los siguientes síntomas:
    1. Rigidez matutina articular mayor de una hora de duración
    2. Artritis de 3 o más articulaciones
    3. Artritis en articulaciones de las manos
    4. Artritis simétrica
    5. Nódulos subcutáneos
    6. Resultados positivos en pruebas de factor reumatoide
    7. Erosiones u osteopenia periarticular en articulaciones de manos o muñecas observadas en radiografías

    E.4Principal exclusion criteria
    • mujeres embarazadas o en periodo de lactancia.
    • hombres y mujeres potencialmente fértiles que no puedan o no deseen utilizar un método anticonceptivo adecuado durante el periodo del estudio y 12 meses después de la última infusión.
    • pacientes con historia médica y enfermedades concomitantes en los que esté contraindicado el tratamiento con rituximab
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la evaluación de los cambios celulares y moleculares inducidos por el tratamiento con rituximab. Para ello, las variables concretamente definidas son:

    • Disminución de la infiltración por células B en sinovial de AR, durante el seguimiento respecto al periodo pre-tratamiento.
    • Disminución de la infiltración por células plasmáticas o de la diferenciación de células B en sinovial de AR.
    • Cambios potenciales en factores hipotéticamente dependientes de células B y relevantes para la patogénesis de la AR, tales como citocinas, quimioquinas, moléculas co-estimulatorias y otras poblaciones celulares.
    • Análisis de diferentes marcadores de la linfoneogénesis sinovial, como HEV, compartimentalización de las células T/células B, células foliculares dendríticas y la expresión de quimioquinas de homing.
    Otras variables que serán evaluadas son:

    • Diferencias en la respuesta terapéutica DAS28 y en la capacidad funcional pre y post tratamiento.
    • Cambios morfológicos de la membrana sinovial, a través del análisis mediante imagen por artroscopia.
    • Cambios potenciales en las subpoblaciones linfocitarias.
    • Correlaciones entre los cambios de marcadores descritos más arriba y la respuesta clínica, comparando pacientes respondedores y no respondedores.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No respondedores
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    El tratamiento con la medicación del estudio puede ser interrumpido si existe una enfermedad concomitante o algún procedimiento médico que requiera la interrupción del tratamiento.
    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 months
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    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 No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 Decision2008-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-29
    P. End of Trial
    P.End of Trial StatusOngoing
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