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    Summary
    EudraCT Number:2012-003230-17
    Sponsor's Protocol Code Number:MO28457
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003230-17
    A.3Full title of the trial
    A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN’S LYMPHOMA GRADES 1, 2 OR 3A
    STUDIO RANDOMIZZATO, IN APERTO, MULTICENTRICO PER VALUTARE LA PREFERENZA DELLA SOMMINISTRAZIONE SOTTOCUTANEA DI RITUXIMAB RISPETTO ALLA SOMMINISTRAZIONE ENDOVENOSA DI RITUXIMAB IN PAZIENTI PRECEDENTEMENTE NON TRATTATI AFFETTI DA LINFOMA DIFFUSO A GRANDI CELLULE B CD20+ O DA LINFOMA NON-HODGKIN FOLLICOLARE CD20+ DI GRADO 1, 2 O 3A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess patient preference after subcutaneous injections of Mabthera versus intravenous infusions Mabthera in previously-untreated patients with diffuse large B-cell lymphoma or follicular non-Hodgkin's lymphoma.
    STUDIO PER VALUTARE LA PREFERENZA DEL PAZIENTE PER LA SOMMINISTRAZIONE SOTTOCUTANEA DI RITUXIMAB RISPETTO ALLA SOMMINISTRAZIONE ENDOVENOSA DI RITUXIMAB IN PAZIENTI PRECEDENTEMENTE NON TRATTATI AFFETTI DA LINFOMA DIFFUSO A GRANDI CELLULE B O DA LINFOMA NON-HODGKIN FOLLICOLARE
    A.4.1Sponsor's protocol code numberMO28457
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche S.p.A.
    B.5.2Functional name of contact pointHead of Clin. Ops Italy
    B.5.3 Address:
    B.5.3.1Street AddressV.le G.B. Stucchi 110
    B.5.3.2Town/ cityMonza (MB)
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 039 247 5070
    B.5.5Fax number+39 039 247 5085
    B.5.6E-mailITALY.INFO_CTA@ROCHE.COM
    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 No
    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/rHuPH20 SC
    D.3.2Product code RO0452294/F04
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 codeRO0452294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Powder and solvent 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.3.9.2Current sponsor codeRO0452294
    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 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
    The target population will consist of adults with previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the World Health Organisation (WHO) classification system
    La popolazione target sarà costituita da adulti affetti da DLBCL CD20+ o NHL follicolare CD20+ di Grado 1, 2 o 3a, precedentemente non trattati secondo il sistema di classificazione dell’OMS
    E.1.1.1Medical condition in easily understood language
    previously untreated CD20-positive diffuse large B-cell lymphoma
    (DLBCL)
    PAZIENTI PRECEDENTEMENTE NON TRATTATI AFFETTI DA LINFOMA DIFFUSO A GRANDI CELLULE B CD20-POSITIVE(DLBCL)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the proportion of patients indicating an overall preference
    via a Patient Preference Questionnaire (PPQ) for either the SC or the IV
    route of rituximab administration.
    • Valutare la percentuale di pazienti che indicano una preferenza complessiva tramite un “Preference Questionnaire” (Questionario sulla Preferenza) per la via di somministrazione di rituximab sottocutanea (s.c.) od endovenosa (e.v.).
    E.2.2Secondary objectives of the trial
    -evaluate the safety of rituximab SC
    -To evaluate and compare the methods of rituximab administration (SC
    vs. IV) in terms of:
    *Rituximab administration time defined as the time from start to end of
    the rituximab SC injection or from start to end of the rituximab IV
    infusion
    *Patient-assessed satisfaction and convenience using the Cancer Therapy Satisfaction Questionnaire(CTSQ)and Rituximab Administration Satisfaction Questionnaire(RASQ)
    -Immunogenicity (anti-rituximab and anti-rHuPH20 antibodies).
    -To evaluate efficacy of rituximab SC in terms of:
    - complete response rate (CR) including complete response unconfirmed
    (CRu), 4-8 weeks after the last dose of induction treatment
    - EFS
    - DFS
    - PFS
    - overall survival (OS).
    -valutare la sicurezza di rituximab s.c.
    -valutare e confrontare i metodi di somministrazione di rituximab(s.c.vs. e.v.)in termini di:
    *tempo di somministrazione di rituximab
    *soddisfazione e comodità valutate dal paziente usando il “Cancer Therapy Satisfaction Questionnaire”(CTSQ=questionario sulla soddisfazione per la terapia antitumorale)ed il “Rituximab Administration Satisfaction Questionnaire”(RASQ=Questionario sulla soddisfazione per la somministrazione di rituximab)
    -immunogenicità (anticorpi anti-rituximab ed anti-rHuPH20).
    -Valutare l’efficacia di rituximab s.c. in termini di:
    *percentuale di risposte complete (CR), compresa la risposta completa non confermata (CRu), 4-8 settimane dopo la conclusione del trattamento
    *sopravvivenza libera da eventi(EFS),da malattia (DFS),DA PROGRESSIONE(PFS)e sopravvivenza globale(OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥ 18 and ≤ 80 years at time of randomization
    -Histologically confirmed, previously untreated CD20+ DLBCL or CD20+
    follicular NHL Grade 1, 2 or 3a, according to the WHO classification
    system
    -An IPI score of 1-4 or IPI score of 0 with bulky disease, defined as
    one lesion ≥ 7.5 cm, or FLIPI (low, low-intermediate, high-intermediate,
    high)
    -At least one bi-dimensionally measurable lesion defined as ≥ 1.5 cm in its largest dimension on CT scan
    -Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
    I pazienti devono soddisfare i seguenti criteri per l’inclusione nello studio (cioè prima della prima dose di rituximab) (Ciclo 1, giorno 1):
    -Modulo di consenso informato scritto, firmato
    -Età &gt; 18 e &lt; 80 anni al momento della randomizzazione
    - DLBCL CD20+ o NHL follicolare CD20+, di Grado 1, 2 o 3°, istologicamente confermato, precedentemente non trattato secondo il sistema di classificazione dell’OMS
    -Un punteggio secondo l’IPI di 1-4 o un punteggio secondo l’IPI di 0 con malattia bulky, definita come una lesione &gt; 7,5 cm, o FLIPI (rischio basso, intermedio od elevato
    -Almeno una lesione misurabile bi-dimensionalmente definita come &gt; 1,5 cm nella sua massima dimensione alla TC.
    -Performance status secondo l’“Eastern Cooperative Oncology Group” (ECOG) ≤ 3.
    E.4Principal exclusion criteria
    1. Transformed lymphoma or FL IIIB
    2. Primary CNS lymphoma, blastic variant of mantle-cell lymphoma,
    histologic evidence of transformation to a Burkitt lymphoma, primary
    mediastinal DLBCL, primary effusion lymphoma, primary cutaneous
    DLBCL or primary DLBCL of the testis
    3. History of other malignancy that could affect compliance with the
    protocol or interpretation of results. This includes a malignancy that has
    been treated but not with curative intent, unless the malignancy has
    been in remission without treatment for ≥ 5 years prior to enrolment.
    Note: Patients with a history of curatively treated basal or squamous
    cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
    are eligible for the study.
    4.Prior therapy for DLBCL or follicular NHL, with the exception of nodal
    biopsy or local irradiation
    5.Prior treatment with cytotoxic drugs (with the exclusion of
    methotrexate for CNS prophylaxis in DLBCL) or rituximab for another
    condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20
    antibody
    6.Prior use of any monoclonal antibody within 3 months prior to
    randomization
    1. Linfoma trasformato o linfoma IIIB follicolare
    2. Linfoma primitivo a carico del SNC, variante blastica del linfoma a cellule a mantello (MCL), evidenza istologica di trasformazione in un linfoma di Burkitt, DLBCL mediastinico primario, linfoma primario con versamento o DLBCL cutaneo primario.
    3. Anamnesi di altri tumori maligni che potrebbero influenzare la conformità con il protocollo o l’interpretazione dei risultati, tra cui un tumore maligno che sia stato trattato ma non con intento curativo, a meno che il tumore maligno non sia stato in remissione senza trattamento per &gt; 5 anni prima dell’arruolamento. Nota: I pazienti con anamnesi di carcinoma a cellule basali o squamose o melanoma della pelle o carcinoma del collo dell’utero in situ trattati curativamente sono eleggibili per lo studio.
    4. Precedente terapia del DLBCL o NHL follicolare, con l’eccezione della biopsia linfonodale o dell’irradiazione locale
    5. Precedente trattamento con farmaci citotossici o rituximab per un’altra affezione (ad es. artrite reumatoide) o precedente impiego di un anticorpo anti-CD20
    6. Precedente impiego di un anticorpo monoclonale entro 3 mesi prima della prima dose di rituximab
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients who prefer Rituximab SC over Rituximab IV
    and the corresponding 95% confidence interval will be estimated
    Per l’endpoint primario della preferenza del paziente, verranno stimati la percentuale di pazienti che preferiscono Rituximab s.c. a Rituximab e.v., ed il corrispondente intervallo di confidenza al 95%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of patient preference will take place when all
    patients have completed induction treatment.
    L'analisi primaria della preferenza da parte del paziente verrà effettuata quando tutti i pazienti avranno completato il loro trattamento di induzione.
    E.5.2Secondary end point(s)
    Safety will be assessed by AEs, AEs of grade ≥ 3, serious adverse
    events (SAEs), premature withdrawal from the study and from study
    medication, laboratory parameters, vital signs and ECOG performance
    status. Adverse events will be coded in MedDRA. The incidence of AEs
    and SAEs will be summarized by primary system organ class and
    preferred term. Laboratory parameters will be presented in shift tables
    of NCI-CTC grade at baseline against worst grade recorded during each
    treatment period and overall. Other safety variables will be summarized.
    The time required for rituximab administration defined as start of
    rituximab SC injection to end of the injection and start of rituximab IV
    infusion to the end of the infusion will be summarized.
    Patient-assessed satisfaction and convenience using RASQ and CTSQ will
    be summarized and presented by treatment group.
    Efficacy endpoints: The Complete Response (CR/CRu) rate measured 4-8 weeks after the end of treatment will be summarized. The time-to-event
    endpoints EFS, DFS, PFS and OS from randomization will be summarized
    overall and by the two treatment sequence groups using the Kaplan
    Meier approach.
    Immunogenicity (anti-rituximab and anti-rHuPH20 antibodies) will be
    summarized
    La sicurezza verrà valutata in base agli eventi avversi (EA), agli EA di grado >3, agli eventi avversi seri (EAS), alle RAA, agli IRR, al ritiro prematuro dallo studio e dal farmaco dello studio, ai parametri di laboratorio di sicurezza, ai segni vitali, al performance status secondo l’ECOG ed ai farmaci concomitanti. Gli eventi avversi verranno codificati nel MedDRA. L’incidenza di EA, di EA che comportino la sospensione prematura o l’interruzione del trattamento dello studio, di EAS, di EA di Grado 3 e 4, delle RAA e degli IRR verrà riassunta in base alla classe del sistema d’organo primario ed al termine preferito. I parametri di laboratorio verranno presentati in tabelle shift di grado NCI-CTC al basale in confronto al grado peggiore registrato durante ciascun periodo di trattamento e complessivamente. Verranno riassunte altre variabili di sicurezza.
    Verrà riassunto il tempo necessario per la somministrazione di rituximab definita come inizio dell’iniezione di rituximab s.c. fino alla fine dell’iniezione ed all’inizio dell’infusione e.v. di rituximab fino alla fine dell’infusione.
    La soddisfazione valutata dal paziente e la comodità verranno riassunte utilizzando i questionari RASQ e CTSQ e presentate per gruppi di trattamento.
    Endpoint dell’efficacia: Verrà riassunta la percentuale di “Complete Response” (Risposta completa) (CR/Cru) misurata 4-8 settimane dopo la fine del trattamento. Gli endpoint “time-to-event” (Tempo all’evento), EFS, DFS, PFS ed OS dalla randomizzazione saranno riassunti complessivamente ed in base ai due gruppi di sequenza del trattamento usando l’approccio di Kaplan Meier.
    Verranno riassunti anche i dati relativi all’immunogenicità (anticorpi anti-rituximab e anti-rHuPH20).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety monitoring of data will be performed periodically by the IDMC.
    The final analysis for the efficacy endpoints (CR/CRu, EFS, DFS, PFS and
    OS) will be provided when the last patient has completed at least 24
    months of follow-up, had disease recurrence, withdrawn from the study,
    been lost to follow up or died, whichever occurs first
    Il monitoraggio della Sicurezza dei dati verrà effettuato periodicamente tramite l'IMDC. L'analisi finale per l'efficacy endpoints (CR/CRu, EFS, DFS, PFS and OS)sarà affettuata quando l'ultimo paziente ha completato i 24 mesi di follow up o in caso di ricaduta di malattia, ritiro dallo studio, perdita al follow up o decesso, a seconda di quale di questi eventi si verifica per primo.
    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 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 Yes
    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 No
    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 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA143
    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
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Croatia
    Dominican Republic
    Egypt
    El Salvador
    Guatemala
    Hong Kong
    Indonesia
    Korea, Democratic People's Republic of
    Malaysia
    New Zealand
    Panama
    Peru
    Philippines
    Switzerland
    Taiwan
    Thailand
    Turkey
    Vietnam
    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
    The end of study, defined as last patient last visit (LPLV) will occur 2 years after the last rituximab administration.
    La fine dello studio (LPLV) avverrà 2 anni dopo che sarà stato completato l’arruolamento dello studio
    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 months41
    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 months41
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 468
    F.4.2.2In the whole clinical trial 900
    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)
    The Sponsor does not intend to provide rituximab IV or rituximab SC to
    patients after conclusion of the study or to patients withdrawing before
    completion of the study.
    Lo Sponsor non intende fornire rituximab IV o rituximab SC ai pazienti dopo la fine dello studio e ai pazienti che si ritirano prima della conclusione dello studio
    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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-20
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