E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic lupus erythematosis (SLE) |
Lupus eritematoso sistémico (LES) |
|
E.1.1.1 | Medical condition in easily understood language |
Systemic lupus erythematosis (SLE) |
Lupus eritematoso sistémico (LES) |
|
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042944 |
E.1.2 | Term | Systemic lupus erythematosis |
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 |
- To evaluate the efficacy of belimumab administered SC in adult subjects with SLE. - To evaluate the safety and tolerability of belimumab administered SC in adult subjects with SLE. |
-Evaluar la eficacia de belimumab administrado por vía subcutánea (SC) a sujetos con lupus eritematoso sistémico. -Evaluar la seguridad y tolerabilidad de belimumab administrado SC a adultos con LES |
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E.2.2 | Secondary objectives of the trial |
not applicable |
No aplicable |
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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 |
Title: Pharmacogenetic Research Date: 17 November 2011 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. |
Título: Estudio Farmacogenómico Fecha: 17 de Noviembre de 2011 Objetivos: - Relación entre las variantes genéticas y la farmacocinética de belimumab. - Relación entre las variantes genéticas y la seguridad o la tolerabilidad de belimumab. -Relación entre las variantes genéticas y la eficacia de belimumab. |
|
E.3 | Principal inclusion criteria |
1. At least 18 years of age. 2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria. 3. Active SLE disease. 4. Autoantibody-positive. 5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.) |
1.Tener al menos 18 años. 2. Tener un diagnóstico clínico de LES conforme a los criterios del American College of Rheumatology (ACR) 3. Tener LES activo. 4. Tener resultados inequívocamente positivos en el análisis de autoanticuerpos 5.Están recibiendo una pauta de tratamiento estable para el LES que consiste en Corticosteroides (ej, prednisona) antipalúdicos (p. ej., hidroxicloroquina) inmunomoduladores, (ej metotrexato, azatioprina, metrotexato, micofenolato. |
|
E.4 | Principal exclusion criteria |
1. Pregnant or nursing. 2. Have received treatment with an B cell targeted therapy (for example, rituximab or belimumab). 3. Have received treatment an investigational biological agent in the past year. 4. Have received IV cyclophosphamide within 90 days of Day 0. 5. Have severe active lupus kidney disease. 6. Have severe active central nervous system (CNS) lupus. 7. Have required management of acute or chronic infections within the past 60 days. 8. Have current drug or alcohol abuse or dependence. 9. Have a positive test for HIV, hepatitis B, or hepatitis C. 10. Have a history of hypersensitivity reactions to contrast agents or biological medicines. |
1. Estar embarazada o en periodo de lactancia 2. Haber recibido cualquier tratamiento dirigido a los linfocitos B (p. ej., rituximab,Belimumab 3. Haber recibido tratamiento con algún medicamento biológico el año pasado. 4. Haber recibido tratamiento con ? Ciclofosfamida 5. Tener signos de enfermedades debido al LES (enfermedades renales). 6. Tener nefritis lúpica grave en el sistema nervioso central (SNC 7. Estar recibiendo actualmente algún tratamiento supresor para una infección crónica en 60 días anteriores. 8. Abuso o dependencia de drogas o alcohol 9. Tener resultados positivos en la selección de anticuerpos contra el VIH 10. Tener antecedentes a reacciones de hipersensibilidad a agentes o medicamentos biológicos |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Outcome Measure:
SLE Responder Index (SRI) response rate; [Time Frame: Baseline, 52 Weeks]. A patient that has an SRI response has all 3 of the following:
- > or =4 point reduction from baseline in SELENA SLEDAI score,
AND
- No worsening (increase of <0.30 points from baseline) in Physician's Global Assessment (PGA),
AND
- No new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (ie, at Week 52). |
El criterio de valoración principal : Es la tasa de respuestas según el Índice de respondedores del lupus eritematoso sistémico (SRI) en la semana 52. Un paciente con respuesta del SRI tiene 3 de los siguientes acontecimientos: - Reducción > o = 4 puntos de la puntuación de SELENA SLEDAI con respecto al momento basal Y -Ausencia de empeoramiento (aumento < 0,30 puntos con respecto al momento basal) en la Evaluación global por el médico (PGA) Y - Ninguna puntuación nueva de dominios orgánicos BILAG A o 2 puntuaciones nuevas de dominios orgánicos BILAG B en comparación con el momento basal (es decir, en la semana 52). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Please refer to point E.5.1 |
Por favor remitirse al punto E.5.1 |
|
E.5.2 | Secondary end point(s) |
Secondary Outcome Measures:
- Time to first severe flare (SLE Flare Index); [Time Frame: Baseline to 52 weeks]
- Reduction in prednisone dose. Percent of subjects whose average prednisone dose has been reduced by < or = 25% from baseline to < or = 7.5 mg/day during Weeks 40 through 52 in subjects receiving greater than 7.5 mg/day at baseline ; [Time Frame: Baseline, Weeks 40-52] |
Criterios de valoración secundarios : 1. Tiempo hasta el primer brote grave (según la medición del Índice de brotes del LES modificado). 2. Reducción de la dosis de prednisona. Porcentaje de pacientes cuya dosis media de prednisona se reduzca en > or = 25% con respecto al momento basal hasta < or = 7,5 mg/día durante las semanas 40 a 52 en sujetos que reciban más de 7,5 mg/día en dicho momento [periodo de tiempo, VBasal, sem40-52] |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
please refer to point E.5.2 |
Por favor remitirse al punto E.5.2 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 56 |
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 |
Argentina |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
Colombia |
Croatia |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
India |
Italy |
Malaysia |
Mexico |
Peru |
Philippines |
Poland |
Portugal |
Romania |
Russian Federation |
Serbia |
Singapore |
Spain |
Sweden |
Taiwan |
Thailand |
Ukraine |
United Kingdom |
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
|
Last patient last visit |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |