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    Summary
    EudraCT Number:2012-003314-13
    Sponsor's Protocol Code Number:P1200_11
    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:2021-06-04
    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 number2012-003314-13
    A.3Full title of the trial
    RItuximab for lupus Nephritis with remission as a Goal
    RItuximab nella Nefrite lupica con remissione come outcome (Goal), studio randomizzato multicentrico internazionale (RItuximab for lupus Nephritis with remission as a Goal)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RItuximab for lupus Nephritis
    RItuximab nella Nefrite lupica
    A.3.2Name or abbreviated title of the trial where available
    RING
    RING
    A.4.1Sponsor's protocol code numberP1200_11
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01673295
    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, BRUXELLES, BELGIUM
    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 Cat
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria Pisana
    B.5.2Functional name of contact pointU.O. Reumatologia
    B.5.3 Address:
    B.5.3.1Street Addressvia Roma 67
    B.5.3.2Town/ cityPisa
    B.5.3.3Post code56126
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 050 558601
    B.5.5Fax number+39 050 558630
    B.5.6E-mailmarta.mosca@med.unipi.it
    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 - 1 FIALA 500 MG 50 ML
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 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.3.9.2Current sponsor codenon applicabile
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    nefrite lupica
    E.1.1.1Medical condition in easily understood language
    lupus nephritis
    nefrite lupica
    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 21.1
    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
    To determine whether the addition of RTX to standard of care (SOC) is more
    efficacious than continued SOC alone to achieve complete renal response (CR) in
    LN patients with persistent proteinuria (=1g/d) despite at least 6 months of SOC
    treatment.
    Dimostrare l’efficacia del Rituximab nell’ottenere una risposta renale completa (CR) in pazienti con LN e proteinuria persistente (=1g/d) nonostante almeno 6 mesi di trattamento standard (SOC).
    E.2.2Secondary objectives of the trial
    Number of deaths;Number of side-effects;Number of SAEs;Number of infections requiring antibiotics ;Number of discontinuations for toxicity;Number of patients reaching ESRD;Number of patients with sustained doubling of serum creatinine or
    sustained fall >25% in GFR;Number of renal flares, nephritic or proteinuric according to Moroni et al.;Time to CR ;Time to CR for patients achieving CR at w104 ;Number of patients achieving a proteinuria <0.2g/d;Number of patients achieving the ACR response criteria for renal disease
    in SLE;Number of mild/moderate and severe flares according the to SELENASLEDAI
    flare index ;Number of patients with normalized serum complement levels;Number of patients with decrease in serum anti-DNA Ab titers by 2
    compared to baseline;Grams equivalent prednisolone exposure; SLICC/ACR DI;All secondary outcomes will be tested (and compared) on the AZA- and
    the MMF-treated populations.
    Numero decessi;numero effetti collaterali;numero SAE;numero infezioni che richiedano tp antibiotica;numero sospensioni per tossicità;numero pazienti che raggiungono ESRD;numero pazienti con raddoppio stabile di creatinina sierica o con una riduzione stabile >25% del GFR;numero riacutizzazioni renali, nefritiche o proteinuriche (definite da Moroni et al.);tempo per raggiungere la risposta completa;tempo per raggiungere la risposta completa nei pazienti che ottengono CR alla settimana 104;numero pazienti che raggiungono una proteinuria <0.2g/d;numero pazienti che raggiungono I criteri di risposta ACR per l’impegno renale;numero riacutizzazioni lievi/moderate o severe secondo il SELENA-SLEDAI flare index;numero pazienti con normalizzazione dei valori sierici di complemento;numero pazienti con riduzione del titolo di anticorpi anti-DNA di 2 volte in confronto al baseline;dose totale di prednisolone;sviluppo di danno;confronto di tali obiettivi fra gruppo con AZA e gruppo con MMF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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) (6
    x 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, at a dose of 2g/day (or the maximal
    tolerated dose)
    iv. AZA for at least 6 months, at a dose of 2 mg/kg/day (or the
    maximal tolerated dose)
    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,
    Version 2.0 – February 6, 2013
    3
    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. diagnosi di lupus eritematoso sistemico (LES) secondo i criteri ACR o i criteri SLICC (Arthritis Rheum 2012; May 2; doi: 10.1002/art.34473);
    2. età =15 anni;
    3. glomerulonefrite lupica ISN/RPS 2003 Classe III (A or A/C), IV (A or A/C ; S or G) o V confermata con biopsia renale eseguita entro 24 mesi prima dello screening;
    4. Avere ricevuto uno dei seguenti quattro trattamenti immunosoppressivi:
    a. Protocollo Euro-Lupus (EL) con ciclofosfamide endovenosa (IVCY) (6 x 500 mg ogni 2 settimane) seguita da azatioprina (AZA) o micofenolato mofetile (MMF) per 3 mesi
    b. Protocollo NIH con IVCY per 6 mesi (6 infusioni mensili) seguita da AZA/MMF per tre mesi
    c. MMF per almeno 6 mesi, alla dose di 2g/die (o la massima dose tollerata)
    d. AZA per almeno 6 mesi, alla dose di 2 mg/kg/die (o la massima dose tollerata)
    Tutti i pazienti al momento dello screening devono assumere AZA o MMF.
    In tutti i protocolli MMF può essere rimpiazzato da acido micofenolico (eMPA);
    5. se in terapia corticosteroidea (GC), la dose massima consentita è di 10 mg equivalenti di prednisolone al giorno allo screening (da almeno 2 settimane);
    6. uP/C ratio =1 (espressa in mg/mg) misurata sulla raccolta delle urine delle 24 ore, confermata alla randomizzazione (w-2) ;
    7. contraccezione (qualsiasi tipo: la astinenza è una alternativa alla contraccezione nei pazienti pediatrici) ;
    8. firma del consenso informato.
    E.4Principal exclusion criteria
    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. Riacutizzazione renale recente o in atto definite come i) : riduzione del filtrato glomerulare stimato (eGFR ; MDRD) =25% nei tre mesi precedenti allo screening o fra lo screening e la randomizzazione; o ii) incremento nella proteinuria =100% fino a >3.5g/d rispetto ad una valutazione precedente;
    2. riduzione della proteinuria 24 ore >50% nei 6 mesi precedenti;
    3. trattamento con =10 mg equivalenti prednisolone/die nelle due settimane precedenti lo screening;
    4. gravidanza o allattamento
    5. non conformità al protocollo
    6. storia di neoplasie (eccetto tumori cutanei diversi dal melanoma o cancro cervicale intraepiteliale)
    7. precedente terapia con Rituximab (effettuata in qualunque momento) o precedente terapia con un altro farmaco biotecnologico (effettuata negli ultimi 6 mesi)
    8. infezione da HIV
    9. infezione attiva da HBV/HCV/TB
    10. severe disfunzioni di fegato, cuore, sistema vascolare, apparato polmonare, gastrointestinale, endocrino, neurologico, ematologico o psichiatrico, che, a giudizio del clinico, controindicherebbero l’inclusione nel protocollo
    E.5 End points
    E.5.1Primary end point(s)
    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.
    percentuale di pazienti capaci di ottenere una risposta renale completa (CR) alla settimana 104.
    CR definita come:
    - uP/C ratio=0,5 (espressa in mg/mg) misurata nella raccolta delle urine delle 24h
    and
    - EGFR=60 ml/min o, se <60 ml/min allo screening, non ridotto di >20% rispetto allo screening
    and
    - nessun aumento della dose di GC durante lo studio(eccetto per due condizioni citate nel protocollo; vide infra)
    and
    - nessuna introduzione di un nuovo immunosoppressore
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 104
    settimana 104
    E.5.2Secondary end point(s)
    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 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 ;
    17. SLICC/ACR DI ;
    18. All secondary outcomes will be tested (and compared) on the AZA- and the MMF-treated populations.
    1. Numero di decessi;
    2. numero di effetti collaterali;
    3. numero di eventi avversi seri (SAE);
    4. numero di infezioni che richiedano terapia antibiotica;
    5. numero di sospensioni per tossicità;
    6. numero d pazienti che raggiungono end stage renal disease (ESRD);
    7. numero di pazienti con raddoppio stabile dei valori di creatinina sierica o con una riduzione stabile >25% del eGFR;
    8. numero di riacutizzazioni renali, nefritiche o proteinuriche come definito da Moroni et al. (Kidney Int 1996; 50 : 2047);
    9. intervallo di tempo necessario per raggiungere la risposta completa;
    10. tempo necessario per raggiungere la risposta completa nei pazienti che ottengono CR alla settimana 104;
    11. numero di pazienti che raggiungono una proteinuria <0.2g/d ;
    12. numero di pazienti che raggiungono I criteri di risposta ACR per l’impegno renale (Arthritis Rheum 2006; 54 : 421);
    13. numero di riacutizzazioni lievi/moderate o severe secondo il SELENA-SLEDAI flare index;
    14. numero di pazienti con normalizzazione dei valori sierici di complemento (misurato centralmente su campiono conservati);
    15. numero di pazienti con riduzione del titolo di anticorpi anti-DNA di 2 volte in confronto ai valori del vaseline (misurati centralmente sui campioni conservati);
    16. quantità totale di prednisolone assunta.
    17. sviluppo di danno;
    18. tutti gli endpoints secondari verranno valutati e confrontati nei pazienti trattati con azatioprina e micofenolato mofetile
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 104
    settimana 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
    terapia standard per la nefrite lupica
    standard of care (SOC)
    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 concerned12
    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 Information not present in EudraCT
    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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    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.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 state24
    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)
    At the end of the study patients will continue their regular disease monitoring and their regular therapeutic scheme based on the standard of care for SLE.
    The timing of their outpatients visits will depend on the severity and the activity of their disease, as recommended in the literature (Mosca M et al. Ann Rheum Dis, 2010)
    Al termine della sperimentazione i pazienti proseguiranno il monitoraggio e la terapia standard per il trattamento del lupus eritematoso sistemico. La scadenza delle valutazioni ambulatoriali dipenderà dalle caratteristiche di severità e attività della malattia come indicato nella letteratura esistente (Mosca M et al. Ann Rheum Dis, 2010)
    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 Decision2015-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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