E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lupus Erythematosus |
Lupus Eritematoso |
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E.1.1.1 | Medical condition in easily understood language |
Lupus Erythematosus |
Lupus Eritematoso |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10028395 |
E.1.2 | Term | Musculoskeletal and connective tissue disorders |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042945 |
E.1.2 | Term | Systemic lupus erythematosus |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objectives of this study are to evaluate the following in adult SLE subjects receiving belimumab plus standard therapy versus subjects receiving placebo plus standard therapy: • Mortality and adverse events of special interest over 1 year (through 52 weeks). • Corticosteroid reduction during Weeks 40-52. |
Gli obiettivi di questo studio sono la valutazione dei seguenti endpoint in soggetti adulti affetti da LES, trattati con belimumab in associazione a terapia standard, rispetto a soggetti trattati con placebo in associazione a terapia standard: • Mortalità ed eventi avversi di interesse particolare nel corso di 1 anno (52 settimane). • Riduzione dei corticosteroidi durante le Settimane 40-52. |
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E.2.2 | Secondary objectives of the trial |
not applicable |
non applicabile |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PHARMACOGENETIC: Vers:Am 1 Date:2012/08/01 Title:Pharmacogenetic Research Objectives:• Relationship between genetic variants and the pharmacokinetics of belimumab. • Relationship between genetic variants and safety and/or tolerability of belimumab. • Relationship between genetic variants and efficacy of belimumab.
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FARMACOGENETICA: Vers:Am 1 Data:2012/08/01 Titolo:Ricerca Farmacogenetica Obiettivi:- stabilire una possibile relazione tra le varianti genetiche e la farmacocinetica di belimumab - stabilire una possibile relazione tra le varianti genetiche e la sicurezza/tollerabilità di belimumab - stabilire una possibile relazione tra le varianti genetiche e l'efficacia di belimumab
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E.3 | Principal inclusion criteria |
• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria. • Active SLE disease. • Autoantibody-positive. • On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate). |
• Diagnosi di LES secondo i criteri rivisti dell'American College of Rheumatology (ACR) • LES attivo • LES autoanticorpo positivo • Regime di trattamento in corso per il LES, che può essere costituito da corticosteroidi (ad es. prednisone), antimalarici (ad es. idrossiclorochina),e/o immunosoppressori (ad es. azatriopina, metotrexato, micofenolato) |
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E.4 | Principal exclusion criteria |
• Pregnant or nursing. • Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days. • Have received a live vaccine within the past 30 days. • Have severe active lupus kidney disease. • Have severe active central nervous system (CNS) lupus. • Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. |
• Gravidanza o allattamento • Trattamento precedente con: belimumab, come prodotto immesso in commercio o come farmaco sperimentale; qualsiasi terapia mirata ai linfociti B (ad es. rituximab) nell'anno precedente; o qualsiasi farmaco biologico (ad es. adalimumab, etanercept, infliximab, o anakinra)nei 90 giorni precedenti • Ha ricevuto la somministrazione di un vaccino vivo nei precedenti 30 giorni • Grave malattia renale causata dal lupus • Lupus attivo grave a carico del sistema nervoso centrale (SNC) • Infezione in corso o pregressa da virus dell'immunodeficienza umana (HIV), da epatite B o epatite C. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Incidence of all-cause mortality 2) Incidence of adverse events of special interest. Summary of the number and percentage of participants with adverse events within 8 prespecified categories: serious infections, non-serious opportunistic infections and other infections of interest, malignancies (excluding nonmelanoma skin cancers), non-melanoma skin cancers, psychiatric events, suicidality, serious infusion and hypersensitivity reactions, and all serious adverse events. |
1) Incidenza della mortalità per qualsiasi causa 2) Incidenza degli eventi avversi di interesse particolare. Sommario del numero e della percentuale di partecipanti con eventi avversi seri che rientrano in 8 categorie predefinite: infezioni serie, infezioni opportunistiche non serie e altre infezioni di interesse, malignità (escluso NMSC), carcinomi cutanei non melanomatosi (NMSC),eventi psichiatrici, suicidalità, reazioni serie correlate all'infusione e da ipersensibilità, e tutti i SAE |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) Incidence of all-cause mortality -Up to 52 weeks 2) Incidence of adverse events of special interest -Up to 52 weeks |
1) Incidenza della mortalità per qualsiasi causa - su 52 settimane 2) Incidenza degli eventi avversi di interesse particolare - su 52 settimane |
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E.5.2 | Secondary end point(s) |
Reduction in prednisone dose. Percent of participants whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52 in participants receiving greater than 7.5 mg/day at baseline. |
Riduzione della dose di prednisone. Percentuale di soggetti la cui dose media di prednisone (o equivalente) sia stata ridotta di ≥ 25% dal basale fino a ≤ 7,5 mg/giorno durante le Settimane dalla 40 alla 52 compresa nei soggetti trattati con più di 7,5 mg/giorno di prednisone al basale. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, weeks 40 to 52. |
Basale, settimane dalla 40 alla 52. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 90 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
European Union |
Argentina |
Australia |
Brazil |
Canada |
Chile |
China |
Colombia |
Croatia |
Hong Kong |
India |
Indonesia |
Israel |
Korea, Democratic People's Republic of |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Peru |
Philippines |
Russian Federation |
Switzerland |
Taiwan |
Thailand |
Turkey |
Ukraine |
United States |
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E.8.7 | Trial 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
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Last subject's 5 year follow up assessment |
visita di follow up al quinto anno dell'ultimo paziente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 10 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |