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    The EU Clinical Trials Register currently displays   42886   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-003437-15
    Sponsor's Protocol Code Number:P170922J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003437-15
    A.3Full title of the trial
    Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome
    Rituximab dès le premier épisode de Syndrome Néphrotique à Lésions Glomérulaires Minimes de l’adulte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome
    A.3.2Name or abbreviated title of the trial where available
    RIFIREINS
    A.4.1Sponsor's protocol code numberP170922J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI - Hôpital Saint Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailagnes.dorion@aphp.fr
    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 AuthorisationFrance
    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 nameMabThera
    D.3.4Pharmaceutical form 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.3.11 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 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: 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.2.5The 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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.13.1Other medicinal product typeHormones systémiques non sexuelles
    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
    Minimal Change Nephrotic Syndrome (MCNS)
    Syndrome Néphrotique à Lésions Glomérulaires Minimes (SNLGM)
    E.1.1.1Medical condition in easily understood language
    Minimal Change Nephrotic Syndrome (MCNS)
    Syndrome Néphrotique à Lésions Glomérulaires Minimes (SNLGM)
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029168
    E.1.2Term Nephrotic syndrome with lesion of minimal change glomerulonephritis
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to demonstrate, from initial episode of MCNS in adults, once complete remission occurred, the efficacy of Rituximab (two injections separated by one week 375mg/m2, with definitive steroids withdrawal after 9 weeks of treatment) compared to the standard regimen of oral steroid alone (progressively tapered within 24 weeks) to prevent relapse after 12 months of follow-up.
    L’objectif principal est de démontrer dès l’épisode initial de SNLGM de l’adulte une fois la RC obtenue, l’efficacité du Rituximab (deux injections à une semaine d’intervalle à la dose de 375mg/m2 avec un arrêt définitif des corticoïdes après une durée totale de 9 semaines) comparativement au protocole classique de corticothérapie avec une décroissance progressive sur 24 semaines sur la réduction du risque de rechute après 12 mois de suivi.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare between the two arms:
    - The relapse rate (number of relapses per person-year) at 12 and 18 months after randomization
    - The time between randomization and relapse (with time points 12 and 18 months after randomization)
    - The type, frequency and the severity of adverse events and serious adverse events during 12 and 18 months
    - The treatment burden that will be assessed at Week-4 before randomization, one week and 16 weeks after randomization
    - The demographics, clinical and/or biological risk factors of relapse at 12 and 18 months follow-up.
    Les objectifs secondaires sont de comparer entre les deux bras :
    - Le taux de rechute (nombre de rechutes par personne-année) à 12 et 18 mois après la randomisation
    - Le temps entre la randomisation et la rechute (après 12 et 18 mois de suivi après la randomisation)
    - Le type, la fréquence et la sévérité des événements indésirables et des événements indésirables graves à 12 et 18 mois de suivi après randomisation
    - Le fardeau du traitement, qui sera évalué 4 semaines avant la randomisation (S-4) puis à une semaine (S1) et à 16 semaines (S16) après la randomisation.
    - Les facteurs démographiques, cliniques et / ou biologiques de la rechute à 12 et 18 mois de suivi.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    RIFIREINS trial will include an extensive B and T lymphocytes subpopulation monitoring with the aim to investigate the potential close relationship between lymphocyte subpopulation and treatment response.
    L'essai RIFIREINS inclura une surveillance étendue des sous-populations de lymphocytes B et T dans le but d'étudier la relation possible entre les sous-populations lymphocytaires et la réponse au traitement.
    E.3Principal inclusion criteria
    - Patient aged ≥ 18 years
    - First episode of Minimal change nephrotic syndrome defined as albumin level < 30 g/L and urine protein/creatinine ratio ≥300mg/mmol
    - Biopsy-proven MCNS defined on renal biopsy examination by the presence of minimal change glomerular lesions and absence of segmental sclerosis by light microscopy, negative immunofluorescence, or presence of IgM deposits into the mesangium
    - Signed informed consent
    - Patients affiliated with the French health care system.
    - Patient âgé de ≥ 18 ans
    - Premier épisode de Syndrome Néphrotique à Lésions Glomérulaires Minimes défini comme un taux d'albumine <30 g / L et un ratio protéines / créatinine urinaire> 300 mg / mmol
    - SNLGM confirmé par une biopsie rénale défini par la présence à l’examen anatomopathologique de lésions glomérulaires minimes et l'absence de lésions de hyalinose segmentaire et focale en microscopie optique et une étude en immunofluorescence négative ou retrouvant la présence de dépôts d'IgM dans le mésangium
    - Signature du consentement éclairé
    - Patients affiliés à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Previous administration of Rituximab therapy
    - MCNS resulting from a secondary process (lymphoid disorders or malignant disease) or potentially related to treatment known to be associated with MCNS occurrence (Lithium, Interferon, non-steroidal anti-inflammatory drugs)
    - Positive serological screening test for HIV, B or C hepatitis
    - Positive immunological tests for antinuclear and anti-DNA antibodies
    - Usual contraindication to steroid or Rituximab
    - Patients with a known allergy to steroid and its excipients or to Rituximab and its excipients
    -Females of childbearing potential who don’t have an effective method of birth control during the study and during the next 12 months after treatment stop
    -Women who are pregnant (positive βHCG at inclusion), or who plan to become pregnant whilst in the trial
    - Breastfeeding women
    - Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
    - Patients who participate simultaneously in another drug trial
    - Patients not willing or able to comply with the protocol requirements
    - Patients who are under tutorship or curatorship
    - Patients ayant déjà reçu du Rituximab
    - SNLGM résultant d'un processus secondaire (hémopathies lymphoïdes ou néoplasie) ou survenant dans les suites de l’administration d’un traitement connu pour être associé à un SNLGM (lithium, interféron, anti-inflammatoires non stéroïdiens)
    - Test de dépistage sérologique positif pour le VIH, l'hépatite B ou C
    - Tests immunologiques positifs pour les anticorps antinucléaires et anti-ADN
    - Contre-indication habituelle aux corticoïdesou au rituximab
    - Patients ayant une allergie connue aux corticoïdeset à ses excipients ou au Rituximab et à ses excipients
    - Femmes en âge de procréer qui n'ont pas de méthode contraceptive efficace pendant l'étude et pendant les 12 mois qui suivent l'arrêt du traitement
    - Femmes qui sont enceintes (βHCG positif à l'inclusion), ou qui envisagent de devenir enceintes pendant l’étude
    - Patients avec une insuffisance cardiaque sévère (Classe IV de la New York Heart Association) ou maladie cardiaque sévère et incontrôlée
    - Patients qui participent simultanément à un autre essai médicamenteux
    - Patients qui ne veulent pas ou ne peuvent pas se conformer aux exigences du protocole
    - Patients sous tutelle ou sous curatelle
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    The incidence of relapse will be analysed using survival analysis. A Cox proportional hazards model will be performed. The incidence of relapse at 12 months follow –up and its 95% confidence interval will be estimated in each study arm.
    Critère principal d’efficacité
    L'incidence de la rechute sera analysée à l'aide d'une analyse de survie. Un modèle de Cox à risques proportionnels sera effectué. L'incidence de la rechute à 12 mois de suivi et son intervalle de confiance à 95 % seront estimés dans chaque bras de l’étude.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    The incidence of relapse at 18 months will be analysed using the same methodology than at 12 months time point.
    Critères secondaires d’efficacité
    L'incidence de la rechute à 18 mois sera analysée en utilisant la même méthodologie qu'à 12 mois.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 mois
    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 No
    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) 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 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 concerned19
    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 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
    last visit of the last subject undergoing the trial
    dernière visite de la dernière personne qui se prête à la recherche
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 148
    F.1.3Elderly (>=65 years) No
    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 state148
    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)
    none
    aucun
    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 Decision2019-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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