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    Summary
    EudraCT Number:2012-003314-13
    Sponsor's Protocol Code Number:P1200_11
    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:2015-06-01
    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 number2012-003314-13
    A.3Full title of the trial
    RING ? RItuximab for lupus Nephritis with remission
    as a Goal, an investigator-initiated randomized international open multicentric study
    Rituximab para la remisión de la nefritis lúpica. Estudio independiente, aleatorizado, internacional, abierto y multicéntrico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RING ? RItuximab for lupus Nephritis with remission
    as a Goal, an investigator-initiated randomized international open multicentric study
    Rituximab para la remisión de la nefritis lúpica.
    A.3.2Name or abbreviated title of the trial where available
    RING
    RING
    A.4.1Sponsor's protocol code numberP1200_11
    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 SponsorCliniques Universitaires Saint Luc, Université catholique de Louvain
    B.1.3.4CountryBelgium
    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 supportCliniques Universitaires Saint Luc, Université catholique de Louvain
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCliniques Universitaires Saint Luc, Université catholique de Louvain
    B.5.2Functional name of contact pointPôle de pathologies rhumatismales
    B.5.3 Address:
    B.5.3.1Street Addressavenue Hippocrate 10
    B.5.3.2Town/ cityBruxelles
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+349322754005774
    B.5.5Fax number+3227645394
    B.5.6E-mailgenevieve.depresseux@uclouvain.be
    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 Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Solution for injection/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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    Lupus Nephritis
    Nefritis lúpica
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis
    Nefritis en pacientes con lupus
    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 18.0
    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
    OBJECTIVE: To test whether RTX is efficacious to achieve complete renal response (CR) in LN patients with persistent proteinuria (?1g/d) despite at least 6 months of standard of care (SOC).
    OBJETIVO: Probar si RTX es eficaz para lograr la respuesta renal completa (CR) en pacientes de LN con proteinuria persistente (?1gd) a pesar de haber estado con tratamiento estándar durante al menos 6 meses.
    E.2.2Secondary objectives of the trial
    1.Number of deaths ;2.Number of side-effects ;3.Number of SAEs ;4.Number of infections requiring antibiotics ;5.Number of discontinuations for toxicity ;6.Number of patients reaching ESRD ;7.Number of patients with sustained doubling of serum creatinine or sustained fall >25% in eGFR ;8.Number of renal flares, nephritic or proteinuric according to Moroni et al. (Kidney Int 1996; 50 : 2047) ;9.Time to CR ;10.Time to CR for patients achieving CR at w104 ;11.Number of patients achieving a proteinuria <0.2g/d ;12.Number of patients achieving the ACR response criteria for renal disease in SLE (Arthritis Rheum 2006; 54 : 421) ;13.Number of mild/moderate and severe flares according the to SELENA-SLEDAI flare index ;14.Number of patients with normalized serum complement levels (centrally measured on stored samples);15.Number of patients with decrease in serum anti-DNA Ab titers by 2 compared to baseline (centrally measured on stored samples);16.Grams equivalent prednisolone exposure;17.
    1. Nº exitus; 2. Nº de acontecimientos adversos; 3. Nº de SAEs; 4. Nº de infecciones que requieren de tto antibiótico; 5. Nº de discontinuaciones por toxicidad; 6. Nº de pacientes que alcanzan enfermedad renal en etapa terminal; 7. Nº de pacientes con duplicación mantenida de creatinina o descenso sostenido >25% en el eGFR; 8. Nº de brotes renales, nefríticos o proteinúricos; 9. Tiempo hasta respuesta renal completa; 10. Tiempo hasta respuesta renal completa en aquellos pacientes que han alcanzado la respuesta renal completa en la S104; 11. Nº de pacientes que alcanzan una proteinuria <0.2 gr/dl; 12. Nº de pacientes que alcanzan respuesta según criterio ACR según evaluación SLE; 13. Nº de pacientes con brotes de intensidad moderada y grave según índice de actividad SELENA-SLEDAI; 14. Nº de pacientes con niveles de complementos séricos normalizados: 15. Nº de pacientes con disminución a la 1/2 en los títulos de Ac anti-DNA respecto al basal; 16. Gr equivalentes a prednisolono expuestos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria (at screening)
    All the following inclusion criteria are to be met :
    1. SLE, according to ACR and/or SLICC (Arthritis Rheum 2012; May 2; doi: 10.1002/art.34473) criteria ;
    2. Age ?15y (except if local ethics committee imposes ?18y) ;
    3. ISN/RPS 2003 Class III (A or A/C), IV (A or A/C ; S or G) or V lupus GN confirmed on renal biopsy performed within 24 months before screening ;
    4. Having received one out of four following immunosuppressive regimens: i): Euro-Lupus (EL) intravenous (IV) cyclophosphamide (CY) (6x 500 mg q2w) followed by AZA/MMF for 3 months; ii): NIH IVCY for 6M (6 monthly pulses) followed by AZA/MMF for 3 months; iii): MMF for at least 6 months; iv): AZA for at least 6 months
    All patients should be on AZA or MMF at screening. In all regimens, MMF can be replaced by enteric-coated mycophenolic acid (eMPA) ;
    5. If on GC, being on maximum 10 mg equivalent prednisolone/d at screening (for at least 2 weeks) ;
    6. uP/C ratio ?1 (expressed in mg/mg) measured in a 24-h urine collection, confirmed at randomization (w-2) ;
    7. Contraception (any type ; sexual abstinence is an alternative to
    contraception in paediatric patients) ;
    8. Signed informed consent (drafted according to local practice and approved by the local ethics committee).
    1. Lupus eritematoso sistémico según la clasificación ACR y/o SLICC
    2. Edad ? 18 años
    3. Nefritis lúpica tipo III/IV/V según clasificación de la ISN/RPS 2003o glomerulonefritis lúpica confirmada mediante biopsia renal en los últimos 24 meses
    4. Haber recibido uno de los siguientes regímenes inmunosupresores:
    i. Ciclofosfamida en pauta Euro-Lupus (EL) intravenosa (IV) (6 x 500 mg cada 2 semanas)
    ii. Ciclofosfamida intravenosa durante 6 meses seguido de
    azatioprina/micofenolato mofetilo durante 3 meses
    iii. Micofenolato mofetilo durante al menos 6 meses, a una dosis de
    2 gr/día (o la máxima dosis tolerada)
    iv. Azatioprina durante al menos 6 meses, a una dosis de 2
    mg/Kg/día (o la máxima dosis tolerada)
    Todos los pacientes deberán estar en tratamiento con Azatioprina o Micofenolato mofetilo en el momento de la preselección. En todos los regímenes, se podrá cambiar el micofenolato mofetilo por ácido micofenólico gastroresistente.
    5. En caso de estar en tratamiento con glucocorticoides, recibir una dosis como máximo equivalente a 10 mg de prednisolona (durante las 2 semanas previas a la preselección).
    6. Índice de proteinuria/creatinina ?1 mg/mg según recolección de 24 h de orina, confirmado en el momento de la aleatorización.
    7. Contracepción (o abstinencia sexual como alternativa a la contracepción)
    8. Firma del consentimiento informado
    Las mujeres en edad fértil deberán presentar una prueba de embarazo negativa dentro de los 10 previos a la inclusión en el estudio.
    E.4Principal exclusion criteria
    Exclusion criteria (at screening, except exclusion criteria 1 at randomization).
    Any of the following :
    1. Recent or ongoing renal flare defined as either i) : fall in estimated glomerular filtration rate (eGFR ; MDRD) ?25% within 3 month prior to screening or between screening and randomization ; or ii) : increase in urine protein by ?100% to >3.5g/d compared to previous assessment ;
    2. 24-h proteinuria decline >50% over previous 6 months ;
    3. Treatment with ?10 mg equivalent prednisolone/d in the last 2 weeks before screening ;
    4. Pregnancy or breast-feeding ;
    5. Anticipated non-compliance with the protocol ;
    6. History of malignancy (except non-melanoma skin and cervical intraepithelial cancer) ;
    7. Previous treatment with RTX (whenever) and previous treatment with another biologic agent within the last 6 months ;
    8. HIV infection ;
    9. Active HBV/HCV/TB infection ;
    10. Severe liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic or psychiatric disturbances, that would contraindicate inclusion in the protocol, as judged by the clinician.
    1. Brote renal reciente o actividad definida como o bien i) disminución en el índice de filtrado glomerular estimado (eGRF; MDRD) ?25% dentro de los 3 mese previos a la preselección o entre la preselección y la aleatorización; o ii) incremento de la proteína en orina del ?100% a > 3.5 gr/dl comparado con una evaluación previa
    2. Disminución de la proteinuria según recolección de 24h de orina > 50% durante los 6 meses previos
    3. Tratamiento con una dosis superior al equivalente de ? 10mg de prednisolona en las últimas 2 semanas previos a la preselección
    4. Embarazo o expectativas de embarazo durante todo el periodo del estudio
    5. Previsión de no cumplimiento con el protocolo del estudio
    6. Antecedentes de neoplasia (excepto cáncer de piel tipo no melanoma y cáncer intraepitelial cervical)
    7. Tratamiento previo con RTX (en cualquier momento) y tratamiento previo con otro tipo de agente biológico durante los últimos 6 meses
    8. Infección por el VIH
    9. Infección activa por VHB / VHC / Tuberculosis
    10. Alteraciones graves hepáticas, cardíacas, vasculares, pulmonares, gastrointestinales, endocrinas, neurológicas, hematológicas o psiquiátricas, que según juicio del médico, podrían contraindicar la inclusión del paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    The primary endpoint is the percentage of patients achieving renal complete response (CR) at w104.
    CR is defined as :
    - uP/C ratio ?0.5 (expressed in mg/mg) measured in a 24-h urine collection;
    and
    - eGFR >= 60ml/min or, if <60ml/min at screening, not fallen by >20% compared to screening;
    and
    - no increase of GC throughout the study (except for two limited courses as per protocol; vide infra);
    and
    - no introduction of another immunosuppressant.
    La variable principal del estudio es el porcentaje de pacientes que alcanzan la respuesta renal completa a las 104 semanas, definida como:
    - índice proteinuria/creatinina ?0.5 mg/mg mediante recolección de orina 24h; y
    - eGFR ?60ml/min o, en caso de ser <60ml/min durante la preselección, no disminución >20% en comparación con la preselección; y
    - no incrementar la dosis de glucocorticoides durante el estudio (excepto un máximo de dos tandas limitadas según el protocolo); y
    - no introducir ningún otro inmunosupresor
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week104
    Semana 104
    E.5.2Secondary end point(s)
    The secondary endpoints (evaluated at w104) are:
    1. Number of deaths ;
    2. Number of side-effects ;
    3. Number of SAEs ;
    4. Number of infections requiring antibiotics ;
    5. Number of drops for toxicity ;
    6. Number of patients reaching ESRD ;
    7. Number of patients with sustained doubling of serum creatinine or sustained fall >25% in eGFR ;
    8. Number of renal flares, nephritic or proteinuric according to Moroni et al. (Kidney Int 1996; 50 : 2047) ;
    9. Time to CR ;
    10. Time to CR for patients achieving CR at w104 ;
    11. Number of patients achieving a proteinuria <0.2g/d ;
    12. Number of patients achieving the ACR response criteria for renal disease
    in SLE (Arthritis Rheum 2006; 54 : 421) ;
    13. Number of mild/moderate and severe flares according the to SELENASLEDAI flare index ;
    14. Number of patients with normalized serum complement levels (centrally
    measured on stored samples);
    15. Number of patients with decrease in serum anti-DNA Ab titers by 2
    compared to baseline (centrally measured on stored samples);
    16. Grams equivalent prednisolone exposure.
    Analyses will be performed on the Intent-To-Treat (ITT) population and the
    17. SLICC/ACR DI ;
    18. All secondary outcomes will be tested (and compared) on the AZA- and the MMF-treated populations.
    1. Número de fallecimientos;
    2. Número de de acontecimientos adversos;
    3. Número de acontecimientos adversos graves;
    4. Número de infecciones que requieren de tratamiento antibiótico;
    5. Número de discontinuaciones por toxicidad;
    6. Número de pacientes que alcanzan enfermedad renal en etapa terminal;
    7. Número de pacientes con duplicación mantenida de la cifra de creatinina sérica o descenso sostenido >25% en el eGFR ;
    8. Número de brotes renales, nefríticos o proteinúricos, según Moroni et al. (KidneyInt 1996; 50:2047);
    9. Tiempo hasta respuesta renal completa;
    10. Tiempo hasta respuesta renal completa en aquellos pacientes que han alcanzado la respuesta renal completa en la semana 104; 11. Número de pacientes que alcanzan una proteinuria <0.2 gr/dl
    12. Número de pacientes que alcanzan respuesta según criterio ACR según evaluación SLE
    13. Número de pacientes con brotes de intensidad moderada y grave según el índice de actividad SELENA-SLEDAI
    14. Número de pacientes con niveles de complementos séricos normalizados
    15. Número de pacientes con disminución a la mitad en los títulos de anticuerpos anti-DNA respecto al momento basal
    16. Gramos equivalentes a prednisolona expuestos
    17. Índice de daño SLICC/ACR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week104
    Semana 104
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Colombia
    European Union
    Morocco
    Russian Federation
    Switzerland
    Turkey
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 179
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 194
    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)
    According to physician's and patient's best judgments
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Lupus Nephritis Trial Network
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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