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    The EU Clinical Trials Register currently displays   41198   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006001-10
    Sponsor's Protocol Code Number:RTX500/1000
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-006001-10
    A.3Full title of the trial
    Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response
    Valutazione di efficacia di Rituximab al dosaggio di 500mg e.v., 2 infusioni a distanza di 2 settimane, in confronto al dosaggio standard di 1000mg e.v., 2 infusioni a distanza di 2 settimane nel mantenimento della buona risposta clinica in pazienti affetti da artrite reumatoide, gia' trattati con Rituximab al dosaggio standard per almeno 2 cicli
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response
    Valutazione di efficacia di Rituximab al dosaggio di 500mg e.v., 2 infusioni a distanza di 2 settimane, in confronto al dosaggio standard di 1000mg e.v., 2 infusioni a distanza di 2 settimane nel mantenimento della buona risposta clinica in pazienti affetti da artrite reumatoide, gia' trattati con Rituximab al dosaggio standard per almeno 2 cicli
    A.4.1Sponsor's protocol code numberRTX500/1000
    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 SponsorA.O. UNIVERSITARIA INTEGRATA DI VERONA
    B.1.3.4CountryItaly
    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 supportReparto Reumatologia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOUI Verona
    B.5.2Functional name of contact pointUnita' Operativa di Reumatologia
    B.5.3 Address:
    B.5.3.1Street AddressPoliclinico GB Rossi, Piazzale L.A. Scuro, 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37134
    B.5.3.4CountryItaly
    B.5.4Telephone number045 6338565
    B.5.5Fax number045 6338686
    B.5.6E-mailsegreteria.reumatologia@ateneo.univr.it
    D. IMP Identification
    D.IMP: 1
    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*EV 1FL 50ML 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Injection
    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 codeNA
    D.3.9.3Other descriptive nameNA
    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 number1000
    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 typeAnticorpo monoclonale
    D.IMP: 2
    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*EV 1FL 50ML 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Injection
    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 codeNA
    D.3.9.3Other descriptive nameNA
    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 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 typeAnticorpo monoclonale
    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
    Artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Artrite reumatoide
    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 LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the present study is to evaluate if rituximab at the dose of 500 mg e.v., two infusions two weeks apart, is as effective as rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis who have been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response
    Scopo del presente studio è quello di valutare in soggetti affetti da artrite reumatoide già in terapia con rituximab, che abbiano ricevuto almeno 2 cicli di terapia alla posologia standard di 1 g x 2 per ogni ciclo, che abbiano ottenuto una buona risposta clinica, se la posologia di 500 mg x 2 sia in grado di mantenere la risposta favorevole precedentemente ottenuta con la posologia standard in confronto a soggetti che continueranno ad essere trattati con 1 g x 2 per ogni ciclo
    E.2.2Secondary objectives of the trial
    -Evaluation of the number of tender joints -Evaluation of the number of swollen joints -Evaluation of the ESR and C-reactive protein -Evaluation of the number of patients in clinical remission (DAS28 < 2.6) -Evaluation of the progression of the anatomic damage by hand and feet X-ray examination -Evaluation of the adverse reactions -Evaluation of the number of B-lymphocytes -Detection of anti-rituximab antibodies -rituximab serum concentration -evaluation of hematosis, kidney and liver function -evaluation of the difference regarding DAS28 at the entry to the study and at the subsequent clinical evaluations until the end of the study
    -Valutazione del numero di articolazioni dolorabili -Valutazione del numero di articolazioni tumefatte -Valutazione dei reattanti della fase acuta (PCR, VES) -Valutazione del numero di pazienti in remissione (DAS28 &lt;2.6) -Valutazione della progressione del danno anatomico visibile radiologicamente -Valutazione dell’incidenza di eventi avversi -Valutazione dei livelli di linfociti B circolanti -Valutazione in merito alla comparsa di anticorpi anti-farmaco -Concentrazione ematica farmaco -valutazione ematosi, funzione epatica e renale -valutazione differenza del DAS28 tra il basale (T0) e ogni successiva valutazione valutazione fino alla fine dello studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients affected by rheumatoid arthritis, diagnosed in agreement with the American College of Rheumatology 1987 criteria, who had been previously treated with rituximab at the usual dose of 1000 mg, two infusions two weeks apart, for at least two cycles, obtaining a good clinical response (reduction of at least 1.2 points of Disease Activity Score DAS28, as observed at the last visit, in comparison with the basal value, before the rituximab treatment start). The patients had previously failed, for inefficacy or intolerance, therapy with either methotrexate and TNF blockers. Age of the patients > 18 years.
    - Pazienti affetti da artrite reumatoide, diagnosticata secondo i criteri ACR del 1987, già in terapia con rituximab alla posologia di 1 g x 2 per ciclo, che abbiano già ricevuto almeno 2 cicli di terapia, ottenendo una buona risposta (riduzione di almeno 1.2 punti del DAS28 rilevata all’ultima visita disponibile, rispetto al dato ottenuto prima dell’inizio della terapia). I pazienti in precedenza sono risultati non responsivi o intolleranti dapprima al Methotrexate e quindi a uno o più farmaci anti-TNF (infliximab, etanercept, adalimumab). - Potranno essere arruolati sia pazienti che stanno ricevendo in associazione a rituximab il Methotrexate o altro immunosoppressore, sia pazienti che - a causa di intolleranza o per scelta personale - hanno interrotto in precedenza l’assunzione di Methotrexate e stanno quindi ricevendo il rituximab in monoterapia. - Potranno essere arruolati sia pazienti afferenti al Day Service Polispecialistico che pazienti ricoverati in regime ordinario, seguiti presso l’USOD di Reumatologia del Policlinico G.B. Rossi di Verona - Età dei pazienti &gt; 18 anni.
    E.4Principal exclusion criteria
    - Hypersensitivity to the drug or to murine proteins or to any component of the product - severe, active infections - severe heart failure (New York Heart Association class IV) or severe uncontrolled heart disease
    - Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti o alle proteine di origine murina. - Infezioni attive, gravi - Scompenso cardiaco grave (classe IV New York Heart Association) o malattia cardiaca grave e non controllabile.
    E.5 End points
    E.5.1Primary end point(s)
    Difference regarding DAS28 at the entry to the study and at the end (T14 – 27 months after the entry) between group A (rituximab 500 mg) and group B (rituximab 1000 mg)
    Differenza del DAS28 tra il basale (T0) e la fine dello studio (T14) fra il gruppo A, trattato con rituximab 500 mg x 2 per ogni ciclo rispetto al gruppo B, trattato con rituximab 1000 mg x 2 per ogni ciclo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and T14
    baseline e T14
    E.5.2Secondary end point(s)
    -number of tender joints -number of swollen joints -concentration of PCR -ESR -number of patients in clinical remission (DAS28 < 2.6) -progression of the anatomic damage by hand and feet X-ray examination -Incidence of adverse reactions -number of B-lymphocytes -Presence of anti-rituximab antibodies -rituximab serum concentration -concentration of hematochemical factors -concentration of kidney and liver related factor -difference regarding DAS28 at the entry to the study and at the subsequent clinical evaluations until the end of the study
    -numero di articolazioni dolorabili -numero di articolazioni tumefatte -CONCENTRAZIONE PCR -VES -numero di pazienti in remissione (DAS28 <2.6) -progressione del danno anatomico visibile radiologicamente -incidenza di eventi avversi -livello di linfociti B circolanti -presenza di anticorpi anti-farmaco -Concentrazione ematica farmaco -concentrazione fattori ematochimici -concentrazione fattori legati a funzione epatica e renale -differenza del DAS28 tra il basale (T0) e ogni successiva valutazione valutazione fino alla fine dello studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, T2, T3, T5, T6, T8, T9, T11, T12, T14
    baseline, T2, T3, T5, T6, T8, T9, T11, T12, T14
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind Yes
    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
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.1Number of subjects for this age range: 0
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-14. Yes
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    At the end of the study, patients will continue rituximab treatment in case of maintenance of a good clinical response. On the basis of clinical judgment (loss of efficacy or adverse reactions), the treatment might be opportunely changed in agreement with the guidelines for the management of rheumatoid arthritis.
    Al termine dello studio, in caso di mantenimento di una buona risposta clinica, i pazienti continueranno a ricevere il farmaco rituximab.
    In caso di perdita di efficacia o di insorgenza di effetti collaterali, il paziente verrà trattato secondo le linee guida di trattamento dell’artrite reumatoide.
    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 Decision2012-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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