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    Summary
    EudraCT Number:2011-005856-32
    Sponsor's Protocol Code Number:RITULUP
    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:2012-01-27
    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 number2011-005856-32
    A.3Full title of the trial
    Comparison of the efficacy of two rituximab treatment regimens in patients with lupus nephropathy
    resistant to conventional treatment
    Comparación de la eficacia de dos regímenes de tratamiento con rituximab en pacientes con nefropatía lúpica resistente a tratamientos convencionales.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two treatments rituximab in patients with autoimmune disease resistant to conventional treatments
    Comparacion de dos tratamientos con rituximab en pacientes con enfermedad autoinmune resistentes a tratamientos convencionales
    A.4.1Sponsor's protocol code numberRITULUP
    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 SponsorFundación Progreso y Salud
    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 supportMinisterio de Sanidad y Politica Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica y Ensayos Clínicos. Hospital Universitario Virgen del Rocio.
    B.5.2Functional name of contact pointClara Maria Rosso
    B.5.3 Address:
    B.5.3.1Street AddressAvda Manuel Siurot s/n
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number34955013414
    B.5.5Fax number34954232992
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    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
    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 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.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    Long-term relapse after treatment of lupus nephritis (LN) resistant to conventional treatment
    Recidiva a largo plazo tras tratamiento de la nefropatía lúpica (NL) resistente al tratamiento convencional,
    E.1.1.1Medical condition in easily understood language
    Long-term relapse after treatment of lupus nephritis (autoinmune disease with renal injury) resistant to conventional treatment
    Recidiva a largo plazo tras tratamiento de la nefropatía lúpica (enfermedad autoinmune con afectación del riñón) resistente al tratamiento convencional
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Rate of complete or partial response to the 12, 18 and 24 months, defined as:
    -Complete response: proteinuria < 0.75 mg per minute (or equivalent in 24h urine, proteinura or urine protein/creatinine index) while maintaining estimated glomerular filtration rate or serum creatinine within the normal range.
    - Partial response: improvement ? 50% and stabilization of kidney function (glomerular filtration of ± 25% compared to the basal value or serum creatinine within the normal range ).
    Tasa de respuesta completa o parcial, a los 12, 18 y 24 meses, definida como:
    - Respuesta completa: proteinuria <0,75 mg por minuto (o equivalente en orina de 24 horas o índice proteína/creatinina en orina) manteniendo un filtrado
    glomerular estimado o creatinina sérica dentro del rango normal.
    Respuesta parcial: mejoría ? 50% y estabilización de la función renal (filtrado glomerular de ± 25% con respecto al valor basal o creatinina sérica dentro del rango normal).
    E.2.2Secondary objectives of the trial
    Proteinuria < 0.75 mg per minute at 12, 18 and 24 months of follow-up. Estimated glomerular filtration or serum creatinine within the normal range at 12, 18 and 24 months of follow-up. Improvement ? 50% of proteinuria, hematuria, or leucoituria 12, 18 and 24 months.
    Proportion of patients who reach a stabilization of kidney function (glomerular filtration of ±25% compared to the basal value or serum creatinine within the normal range) 12, 18 and 24 months of follow-up. Active urinary sediment in a basal position with an inactive urine sediment at 12, 18 and 24 months of follow-up.
    Proteinuria <0,75 mg/min a los 12, 18 y 24 meses. Filtrado glomerular estimado o creatinina sérica dentro del rango normal a los 12, 18 y 24 meses. mejoría ?50% tanto de la proteinuria, hematuria o leucoituria a los 12, 18 y 24 meses. Proporción de pacientes que alcanzan una estabilización de la función renal (filtrado glomerular de ±25% con respecto al valor basal o creatinina sérica dentro del rango normal) a los 12, 18 y 24 meses. sedimento urinario activo en situación basal que presentan un sedimento urinario inactivo a los 12, 18 y 24 meses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Both men and women between 18 and 70 years.

    -Patient with active lupus nephritis, previously treated with the following immunosuppressive unless contraindication: cyclophosphamide, azathioprine and mycophenolate (sodium or mophetil), who have not received rituximab in the two previous years, in whom regime was ineffective at least 3 months after treatment, or who experienced relapse during this time.

    - Informed consent form signed.
    - Pacientes de ambos sexos con edad comprendida entre los 18 y los 70 años.

    - Pacientes con NL activa que hayan sido tratados previamente con los siguientes inmunosupresores, salvo contraindicación: ciclofosfamida, azatioprina y micofenolato (sódico o de mofetilo), que no hayan recibido rituximab en los 2 años previos, en los que dicho régimen haya resultado ineficaz tras al menos 3 meses de tratamiento, o bien que hayan experimentado recaída durante el mismo.

    - Las mujeres en edad fértil deberán tener un prueba de embarazo en suero u orina negativa en la visita de selección, y deberán utilizar un método anticonceptivo adecuado, al menos desde los 14 días previos a su inclusión en el estudio y hasta los 12 meses siguientes a la última dosis de la medicación del ensayo.

    - Pacientes que hayan firmado e consentimiento informado.
    E.4Principal exclusion criteria
    -Active/sepsis serious infections

    -Known neoplasia

    - Heart failure with III/IV functional class

    -Pregnancy

    -Nursing

    -Known anaphylaxis to the product

    -Cardiovascular disease or uncontrolled hypertension

    -Chronic hepatitis B

    -Serious Citopenia (granulocytes < 500/mm3, further < 10000/mm3)

    -Immunodeficiency (CVI, IgA deficiency)

    -Infection with HIV
    - Infecciones graves activas/sepsis
    - Neoplasia conocida. Insuficiencia cardiaca en clase funcional III/IV
    - Embarazo
    - Lactancia
    - Anafilaxia conocida al producto
    - Enfermedad cardiovascular o hipertensiva no controlada
    - Infección crónica por hepatitis B
    - Citopenia grave (neutrófilos <500/mm3, plaquetopenia < 10000/mm3)
    - Inmunodeficiencias (IVC, deficiencia IgA)
    - Infección por VIH
    E.5 End points
    E.5.1Primary end point(s)
    Rate of complete or partial response defined as:
    -Complete response: proteinuria < 0.75 mg per minute (or equivalent in 24h urine, proteinura or urine protein/creatinine index) while maintaining estimated glomerular filtration rate or serum creatinine within the normal range.
    - Partial response: improvement ? 50% and stabilization of kidney function (glomerular filtration of ± 25% compared to the basal value or serum creatinine within the normal range ).
    Respuesta, completa o parcial, definida como:
    La respuesta completa se define como proteinuria <0,75 mg por minuto (o equivalente en proteinura de 24 horas o índice proteína/creatinina en orina) manteniendo un filtrado
    glomerular estimado o creatinina sérica dentro del rango normal.
    o La respuesta parcial se define como una mejoría de la protenuria ? 50% y estabilización de la función renal (filtrado glomerular de ± 25% con respecto al valor basal o creatinina sérica dentro del rango normal).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12, 18 and 24 months
    12, 18 y 24 meses
    E.5.2Secondary end point(s)
    - Proteinuria < 0.75 mg per minute
    - Estimated glomerular filtration or creatinine albumin within the normal range
    - Improvement ? 50% of proteinuria, hematuria, or leucoituria
    - Proportion of patients who reach a stabilization of kidney function glomerular filtrate of ± 25% compared to the basal value or creatinine albumin within the normal range).

    - Active urinary sediment in basal situation presenting a urine sediment inactive in the follow-up.

    Active urinary sediment is defined by one of the following (in the absence of an infection of the urinary tract): hematies > 20 U/mcl or leukocytes > 30 U/mcl

    - Inactive urine sediment is defined by hematies < 20 U/mcl and leukocytes < 30 U/mcl

    - Duration of the renal response

    - Number of cycles of RTX administered in the period of study.

    - Incidence of adverse events (AA), serious adverse events (AAG), and AA that led to the interruption of the study.
    - Proteinuria <0,75 mg por minuto
    - filtrado glomerular estimado o creatinina sérica dentro del rango normal - mejoría ?50% tanto de la proteinuria, hematuria o leucoituria
    -Proporción de pacientes que alcanzan una estabilización de la función renal (filtrado glomerular de ± 25% con respecto al valor basal o creatinina sérica dentro del rango normal)
    - Sedimento urinario activo en situación basal que presentan un sedimento urinario inactivo en el seguimiento
    Sedimento urinario activo se define por una de las siguientes (en ausencia de una infección
    del tracto urinario): hematíes > 20 U/mcl y/o leucocitos >30 U/mcl
    - Sedimento urinario inactivo se define por hematíes < 20 U/mcl y leucocitos <30 U/mcl
    - Duración de la respuesta renal
    -Número de ciclos de RTX administrados en el periodo de estudio.
    - Incidencia de acontecimientos adversos (AA),
    acontecimientos adversos graves (AAG), y AA que llevaron a la interrupción del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 18 and 24 months
    12, 18 y 24 meses
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    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 No
    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
    Recruitment: one year, renewable, if not achieved
    expected sample size. -Treatment: 12 months later .- Follow-up: one year
    Reclutamiento: un año, prorrogable, si no se ha conseguido el
    tamaño de la muestra esperado. -Tratamiento: 12 meses.- Seguimiento posterior: un año
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state36
    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)
    It is no different from normal treatment of this condition
    No difiere de los cuidados habituales para la patología
    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 Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-27
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