E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic lupus erythematosus |
Lupus Eritematoso Sistemico |
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E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
|
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 primary objective of the study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with SLE |
Lâobiettivo primario dello studio e` valutare la sicurezza e la tollerabilita` di un trattamento a lungo termine con epratuzumab in soggetti affetti da LES |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to assess the efficacy and immunogenicity of long-term epratuzumab treatment in subjects with SLE |
Come obiettivi secondari lo studio si propone di valutare lâefficacia e lâimmunogenicita` del trattamento a lungo termine con epratuzumab in soggetti affetti da LES |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The subject has completed double-blind study SL0009 or SL0010, or the subject has terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy, as described in the respective protocols and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012. The subject has completed open-label study SL0006 or SL0008, and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012. - The subject has maintained the eligibility requirements (including concomitant medication restrictions) throughout their participation in the prior study. - Woman of childbearing potential using an acceptable method of birth control. - Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for a period of 3 months after their final dose of study drug |
1. Il soggetto ha completato lo studio in doppio cieco SL0009 o SL0010, oppure lo ha interrotto anticipatamente alla Settimana 16 o in un momento successivo per mancanza di efficacia, come descritto nei rispettivi protocolli, e nellâopinione dello sperimentatore, continuerebbe a beneficiare del trattamento continuativo con epratuzumab nellâambito dello studio SL0012. Il soggetto ha completato lo studio in aperto SL0006 o SL0008 e, nellâopinione dello sperimentatore, continuerebbe a beneficiare del trattamento continuativo con epratuzumab nellâambito dello studio SL0012. 2. Il soggetto ha rispettato i criteri di idoneità (comprese le limitazioni inerenti ai trattamenti concomitanti) per lâintero periodo di partecipazione allo studio precedente. 3. Le donne in età fertile devono acconsentire allâuso di un metodo contraccettivo accettabile durante lo studio. 4. I soggetti di sesso maschile devono accettare di utilizzare e far utilizzare alla/e loro partner/s un metodo contraccettivo adeguato per lâintera durata dello studio e per i 3 mesi successivi allâultima somministrazione di farmaco in studio. |
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E.4 | Principal exclusion criteria |
- Subject has active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease. - Subject has active, severe, SLE disease activity which involves the renal system defined by BILAG renal level A activity. - Evidence of an immunosuppressive state. - Subjects with a history of chronic infections, including but not limited to subjects with concurrent acute or chronic viral hepatitis B or C. - Subjects with substance abuse/dependence or other concurrent medical conditions. - Subjects with significant hematologic abnormalities. - History of malignant cancer. - Subject has used the prohibited medications |
- Il soggetto e` affetto da forma attiva e grave di LES neuropsichiatrico, definito da punteggio BILAG di grado A; - Il soggetto e` affetto da LES in forma attiva e grave che coinvolge lâapparato renale (attivita` renale di livello A secondo lâindice BILAG); - Evidenza di stato immunosoppressivo; - Soggetti con una storia di infezioni croniche, compresi, a titolo puramente esemplificativo, i soggetti con epatite virale B o C concomitante acuta o cronica; - Soggetti in condizione di abuso/dipendenza da sostanze o affetti da altri disturbi medici concomitanti; - Soggetti con anomalie ematologiche significative; - Storia di neoplasie maligne; - il soggetto ha fatto uso di farmaci non consentiti. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percent of subjects meeting treatment response criteria at Week 48 and Week 96 according to a combined response index |
La variabile di efficacia primaria corrisponde alla percentuale di soggetti responder alla Settimana 48 e alla Settimana 96 secondo un indice di risposta combinata. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
48 and 96 weeks |
Settimana 48 e 96 |
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E.5.2 | Secondary end point(s) |
The percent of subjects meeting treatment response criteria at time points other than Week 48 and Week 96, according to the combined index |
La percentuale di soggetti responder ad ulteriori tempi di rivelazione dell'endpoint rispetto alla Settimana 48 e alla Settimana 96, secondo un indice di risposta combinata. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline - 96 weeks |
Basale - 96 settimane |
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 100 |
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 |
Australia |
Brazil |
Canada |
Hong Kong |
India |
Israel |
Korea, Republic of |
Mexico |
Russian Federation |
South Africa |
Taiwan |
Ukraine |
United States |
|
E.8.7 | Trial 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
|
The end of study is defined as the date of the last visit of the last subject in the study |
Conclusione sperimentazione: ultima visita ultimo paziente dello studio |
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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 | 4 |
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 | 4 |
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 |