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    EudraCT Number:2011-000242-38
    Sponsor's Protocol Code Number:BEL114674
    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:2012-12-11
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000242-38
    A.3Full title of the trial
    A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy
    Studio di 2 anni sull'efficacia e la sicurezza di belimumab per via endovenosa verso placebo in soggetti con nefropatia membranosa idiopatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 2 year study to investigate belimumab in membranous nephropathy
    Studio di 2 anni per valutare belimumab nella nefropatia membranosa idiopatica
    A.4.1Sponsor's protocol code numberBEL114674
    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.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.4Telephone number800786766 o +44 208 990 4466
    B.5.5Fax number+44 208 990 1234
    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. name BENLYSTA
    D. of the Marketing Authorisation holderGlaxo Group 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 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 INNBELIMUMAB
    D.3.9.1CAS number 356547-88-1
    D.3.9.2Current sponsor codeGSK1550188
    D.3.9.4EV Substance CodeSUB25607
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Membranous Nephropathy (IMN)
    Nefropatia membranosa idiopatica(NMI)
    E.1.1.1Medical condition in easily understood language
    Idiopathic Membranous Nephropathy (IMN)
    Nefropatia membranosa idiopatica(NMI)
    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 10027170
    E.1.2Term Membranous nephropathy
    E.1.2System Organ Class 100000004857
    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 efficacy of 10mg/kg belimumab for the treatment of IMN
    Valutare l’efficacia di belimumab 10 mg/kg nel trattamento della NMI.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of belimumab 10mg/kg over a 2 year period in IMN. • To evaluate the pharmacokinetics of belimumab in IMN. •To evaluate the effect of belimumab on pharmacodynamic markers and other markers of autoimmunity and their relationship with clinical efficacy in IMN. • To evaluate the effect of belimumb on quality of life in IMN. • To evaluate the benefit of earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens.
    •Valutare la sicurezza e la tollerabilità di belimumab 10 mg/kg nel trattamento della NMI in un periodo di 2 anni. •Valutare la farmacocinetica di belimumab nella NMI. •Valutare l’effetto di belimumab sui marker farmacodinamici e su altri marker di autoimmunità, nonché la loro relazione con l’efficacia clinica nella NMI. •Valutare l’effetto di belimumab sulla qualità della vita nella NMI. •Valutare i vantaggi di un trattamento precoce con belimumab rispetto all’inizio tardivo della terapia con gli attuali regimi di trattamento con i farmaci immunosoppressori.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent. 2. Histological diagnosis: Have new clinical diagnosis of IMN, as verified by biopsy (either by light microscope with immuno-fluorescence, or by electron microscope) in the last 3 years (biopsy results should be available for independent evaluation). 3. Proteinuria: Have clinically active disease (nephrotic range proteinuria) for at least 3 months prior to screening and no improvement (<30% reduction), despite supportive therapy (which must include maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may include statins, diuretics, dietary salt restriction). 4. Female Subjects: A female subject is eligible to participate if she is not pregnant or nursing and at least one of the following conditions apply: a. Non-childbearing potential b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose
    1.Età e sesso: soggetti di sesso maschile o femminile di età compresa tra i 18 e i 75 anni (inclusi) al momento della firma del consenso informato.2Diagnosi istologica: diagnosi clinica di NMI, verificata in seguito a biopsia (mediante microscopia in immunofluorescenza o microscopia elettronica), negli ultimi 3 anni (i risultati della biopsia devono essere disponibili per la valutazione indipendente). 3. Proteinuria: presenza di malattia clinicamente attiva (proteinuria nel range della sindorme nefrosica) da almeno 3 mesi prima dello screening e senza alcun miglioramento (riduzione &lt;30%) nonostante la terapia di supporto (che deve comprendere un ACEi o un ARB alle massime dosi tollerate, salvo controindicazioni, e può comprendere statine, diuretici, riduzione dell’apporto alimentare di sodio). 4.Soggetti di sesso femminile: sono eleggibili per la partecipazione se non sono in gravidanza o in allattamento e se almeno una delle condizioni indicate di seguito risulta applicabile: a.Donne non potenzialmente fertili b. Donne potenzialmente fertili che accettano di utilizzare uno dei metodi di contraccezione elencati nella Sezione 8.1 del protocolloper un adeguato periodo di tempo (come stabilito nella scheda tecnica del prodotto o dallo sperimentatore) prima dell’inizio della somministrazione, al fine di ridurre sufficientemente il rischio di gravidanza in quel momento. I soggetti di sesso femminile devono acconsentire a utilizzare metodi di contraccezione per 16 settimane dopo l’ultima dose.
    E.4Principal exclusion criteria
    1. Non-Idiopathic MN or other condition affecting the kidney: If the diagnosis of MGN is secondary to other conditions, or the subject has renal impairment from a condition that is not MN. 2. Anti-PLA2R autoantibody: Patients known to be negative for anti-PLA2R autoantibody. 3. Severely reduced or deteriorating kidney function: An eGFR at screening < 40 mL/min/1.73m2 (as determined by 4 variable version MDRD equation) or kidney function not stable (as defined by > 15% decrease in eGFR in 3 months before screening). 4. Blood Pressure: Uncontrolled hypertension 5. Prior Therapy: Have received treatment with the following therapies at the times specified prior to Day 0:(please see protocol page 42 for further information) 6. Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. 7. Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. 8. Acute or chronic infection: Have required management of acute or chronic infections, please view section 5.2.2 of the protocol for further information. 9. Liver disease: Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 10. Other diseases/conditions: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to IMN which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. Please view section 5.2.2 of the protocol for further information. 11. Positive serology: Have a historically positive HIV test or test positive at screening for HIV. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs please view section 5.2.2 of the protocol for further information. 12. Liver function tests: AST and ALT ≥2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 13. Immunodeficiency: Have an IgA deficiency (IgA level < 10 mg/dL) or have IgG level <250 mg/dL and have previously received any non-glucocorticoid immunosuppression during the previous 6 months. 14. Laboratory test abnormalities: Have clinically significant abnormalities in screening laboratory assessments (not related to the disease), as judged by investigator. 15. Drug sensitivity / Anaphylaxis: History of sensitivity or intolerance to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies. 16. Suicidality: Subjects who have evidence of serious suicide risk 17. Substance abuse: Evidence of current drug or alcohol abuse or dependence. 18. Blood donation: Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    1.NM non idiopatica o altra condizione a carico dei reni: diagnosi di glomerulonefrite membranosa secondaria ad altre condizioni o presenza insufficienza renale dovuta ad una condizione diversa dalla NM 2. Anticorpi anti-PLA2R: pazienti negativi per anticorpi anti-PLA2R. 3. Funzionalità renale gravemente ridotta o in deterioramento: eGFR allo screening &lt;40 mL/min/1,73m2 (calcolata mediante l’equazione MDRD a 4 variabili) o funzionalità renale instabile (definita da una riduzione &gt;15% dell’eGFR nei 3 mesi precedenti lo screening). 4. Pressione arteriosa: ipertensione non controllata Terapia pregressa: trattamento con terapie specifiche in determinati momenti prima del Giorno 0 (fare riferimento alla sezione n.5.2.2 del protocollo per ulteriori informazioni 6. Trapianto: storia di un trapianto di organi o di cellule staminali ematopoietiche/midollo. 7. Cancro: anamnesi positiva per neoplasia maligna negli ultimi 5 anni, ad eccezione di un cancro cutaneo (baso- o squamocellulare) adeguatamente trattato o di un carcinoma in situ della cervice uterina.8. Infezione acuta o cronica: necessità di trattamenti per infezioni acute o croniche 9. Epatopatie: epatopatia attiva o cronica, o anomalie epatiche o biliari note (ad eccezione della sindrome di Gilbert o di calcoli biliari asintomatici). 10 Altre patologie/condizioni: evidenze cliniche di patologie acute o croniche significative instabili o non controllate non dovute a NMI che, secondo l’opinione dello sperimentatore, potrebbero confondere i risultati dello studio o esporre il soggetto a un rischio eccessivo. 11. Sierologia positiva: fare riferimento alla sezione 5.2.2 del protocollo per ulteriori informazioni. 12. Test di funzionalità epatica: AST e ALT´é│2 volte il limite superiore della norma; fosfatasi alcalina e bilirubina &gt;1,5 volte il limite superiore della norma (un valore isolato di bilirubina &gt;1,5 volte il limite superiore della norma è accettabile se la bilirubina è frazionata e se la bilirubina diretta è &lt;35%). 13. Immunodeficienza: deficit di IgA (livello di IgA &lt;10 mg/dL) o livello di IgG &lt;250 mg/dL in pazienti sottoposti a terapia immunosoppressiva con farmaci non glucocorticoidi nei 6 mesi precedenti. 14. Anomalie ai test di laboratorio: anomalie clinicamente significative alle valutazioni di laboratorio di screening (non correlate alla patologia), secondo il giudizio dello sperimentatore. 15.Sensibilità ai farmaci / anafilassi: anamnesi positiva per sensibilità o intolleranza a uno dei farmaci in studio o ai componenti dei medesimi, o anamnesi positiva per allergia a farmaci o allergia di altro tipo che, secondo l’opinione dello sperimentatore o del Medical Monitor di GSK, rappresenta una controindicazione alla partecipazione. Pregressa reazione anafilattica alla somministrazione parenterale di mezzi di contrasto, proteine umane o murine, o anticorpi monoclonali. 16. Suicidalità: soggetti con evidenza di rischio serio di suicidio. 17. Abuso di sostanze: evidenze di un attuale abuso di alcol o droghe o di un’attuale dipendenza da tali sostanze. 18.Donazioni di sangue: casi in cui la partecipazione allo studio comporterebbe la necessità di ricorrere a donazioni di sangue ed emoderivati superiori a 500 mL in un periodo di 56 giorni.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of remission (complete or partial) at Week 104 (complete remission [CR] is defined as uPCR < 30mg/mmol (proteinuria <0.3g protein/24h) with no worsening of renal function (less than 15% reduction in eGFR from baseline); partial remission [PR] is defined as uPCR < 350mg/mmol [proteinuria <3.5g /24hrs] but ≥ 30mg/mmol [proteinuria ≥0.3g /24hrs] AND a decrease of > 50% from baseline (Day 0) based on uPCR, together with no worsening of renal function [less than 15% reduction in eGFR from baseline]).
    Incidenza della remissione (completa o parziale) alla settimana 104. La remissione completa (CR) è definita come uPCR <30 mg/mmol (proteinuria <0,3 g proteine/24 ore) senza peggioramento della funzionalità renale (riduzione dell’eGFR <15% rispetto al basale); la remissione parziale (PR) è definita come uPCR <350 mg/mmol (proteinuria <3,5 g/24 ore) ma ≥30 mg/mmol (proteinuria ≥0,3 g/24 ore) E come una riduzione >50% rispetto al basale (Giorno 0) della uPCR, senza peggioramento della funzionalità renale (riduzione dell’eGFR <15% rispetto al basale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    104 weeks
    104 settimane
    E.5.2Secondary end point(s)
    Incidence of progression of IMN or failure to. 2. ESRD (eGFR <15mL/min/1.73m2, dialysis or transplantation) 3. Thromboembolism 4. Death Other Secondary Endpoints • Time to complete remission • Time to partial remission • Change from baseline in proteinuria levels at Week 104 • Change from baseline in serum albumin levels at Week 104 • Change from baseline in eGFR at Week 104 • Time to first thromboembolic event • Change from baseline in KDQOL-36 score at Week 104 • Incidence of partial remission at Week 104 • Incidence of complete remission at Week 104 • Duration of remission (complete or partial) • Risk-benefit calculation based on key efficacy and safety endpoints using a clinical utility index Key Safety Endpoints • Incidence of serious adverse events (SAEs) • Incidence of serious infections
    1.Incidenza della progressione della NMI o mancata risposta. 2. ESRD (eGFR <15 mL/min/1,73m2, dialisi o trapianto). 3Tromboembolia. 4.Decesso Altri Endpoint Secondari: Tempo alla remissione completa; Tempo alla remissione parziale; Variazione rispetto al basale dei livelli di proteinuria alla settimana 104 ; Variazione rispetto al basale dei livelli sierici di albumina alla settimana 104, Variazione rispetto al basale dell’eGFR alla settimana 104; Tempo intercorso fino al primo evento trombo embolico; Variazione rispetto al basale del punteggio al questionario KDQOL-36 alla settimana 104; Incidenza della remissione parziale alla settimana 104; Incidenza della remissione completa alla settimana 104; Durata della remissione (completa o parziale); Calcolo del rischio-beneficio in base ai principali endpoint di efficacia e sicurezza mediante un indice di utilità clinica. Principali endpoint di sicurezza: Incidenza di eventi avversi gravi; Incidenza di infezioni gravi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    104 weeks
    104 settimane
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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 No
    E.8.1.3Single blind No
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    United States
    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
    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 months40
    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 months40
    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: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 94
    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)
    Subjects will not receive any additional treatment from GSK after completion of the study because other treatment options are available and for subjects in remission,the value of belimumab maintenance therapy is unclear.Equally for pt. who have not achieved remission with belimumab by 2 years, the value of extending therapy beyond 2 years is unclear. The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient’s medical condition.
    GSK non fornirà alcun trattamento dopo il completamento dello studio in quanto esistono altre opzioni terapeutiche e per i soggetti in remissione non è chiaro il ruolo della terapia di mantenimento con belimumab. Analogamente per i soggetti che non hanno avuto la remissione dopo 2 anni di terapia, non è chiaro il beneficio di un’estensione della stessa. Sarà cura del PI assicurare una corretta terapia dopo il completamento 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 Decision2012-11-22
    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
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