49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-020859-30-IT (EUCTR) | 23/06/2012 | 06/03/2012 | Open-label study of long-term Epratuzumab treatment in subjects withSystemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic lupus erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB Other descriptive name: NA | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 2 | EUCTR2010-020859-30-EE (EUCTR) | 15/06/2012 | 04/06/2012 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 3 | EUCTR2010-018563-41-EE (EUCTR) | 09/04/2012 | 09/03/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 4 | EUCTR2010-018563-41-LT (EUCTR) | 14/03/2012 | 14/02/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 5 | EUCTR2010-020859-30-BG (EUCTR) | 18/11/2011 | 18/07/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 6 | EUCTR2010-020859-30-LT (EUCTR) | 10/10/2011 | 11/08/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 7 | EUCTR2010-018565-26-IT (EUCTR) | 15/09/2011 | 05/01/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;Italy;India | ||
| 8 | EUCTR2010-018563-41-BG (EUCTR) | 02/09/2011 | 25/07/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 9 | EUCTR2010-020859-30-DE (EUCTR) | 31/08/2011 | 24/01/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 10 | EUCTR2010-018563-41-IT (EUCTR) | 23/06/2011 | 20/03/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 11 | EUCTR2010-018563-41-DE (EUCTR) | 21/06/2011 | 21/01/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 12 | EUCTR2010-018565-26-DE (EUCTR) | 21/06/2011 | 21/01/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India | ||
| 13 | EUCTR2010-020859-30-BE (EUCTR) | 25/05/2011 | 19/11/2010 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Estonia;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 14 | EUCTR2010-018563-41-BE (EUCTR) | 25/05/2011 | 19/11/2010 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Belgium;Brazil;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 15 | EUCTR2010-020859-30-GB (EUCTR) | 17/05/2011 | 09/02/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 16 | EUCTR2010-018565-26-GB (EUCTR) | 13/05/2011 | 09/02/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;Italy;United Kingdom;India | ||
| 17 | EUCTR2010-018563-41-GB (EUCTR) | 13/05/2011 | 09/02/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 18 | EUCTR2010-020859-30-CZ (EUCTR) | 25/02/2011 | 26/01/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 19 | EUCTR2010-018563-41-CZ (EUCTR) | 25/02/2011 | 26/01/2011 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 20 | EUCTR2010-018565-26-ES (EUCTR) | 22/02/2011 | 23/12/2010 | Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2 | Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2 | Lupus Sistémico Eritematoso MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Hungary;Spain;Germany;Italy;United Kingdom | |||
| 21 | EUCTR2010-020859-30-ES (EUCTR) | 22/02/2011 | 22/12/2010 | ESTUDIO EN FASE 3, MULTICÉNTRICO, ABIERTO Y DEEXTENSIÓN, PARA EVALUAR LA EFICACIA Y LATOLERABILIDAD DEL TRATAMIENTO CONEPRATUZUMAB EN PACIENTES CON LUPUSERITEMATOSO SISTÉMICO (EMBODY 4) - EMBODY 4 | ESTUDIO EN FASE 3, MULTICÉNTRICO, ABIERTO Y DEEXTENSIÓN, PARA EVALUAR LA EFICACIA Y LATOLERABILIDAD DEL TRATAMIENTO CONEPRATUZUMAB EN PACIENTES CON LUPUSERITEMATOSO SISTÉMICO (EMBODY 4) - EMBODY 4 | Lupus eritematoso sistémico MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Hungary;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | |||
| 22 | EUCTR2010-018563-41-ES (EUCTR) | 21/02/2011 | 22/12/2010 | Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1 | Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1 | Lupus eritematoso sistémico MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | ||
| 23 | EUCTR2010-020859-30-HU (EUCTR) | 08/02/2011 | 10/02/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 24 | EUCTR2010-018565-26-HU (EUCTR) | 16/01/2011 | 22/11/2010 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India | ||
| 25 | EUCTR2007-002589-37-GB (EUCTR) | 17/07/2008 | 04/01/2008 | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Spain;Belgium;Lithuania;United Kingdom | ||
| 26 | EUCTR2007-002566-35-HU (EUCTR) | 09/06/2008 | 28/01/2008 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 27 | EUCTR2007-002589-37-HU (EUCTR) | 09/06/2008 | 29/01/2008 | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 28 | EUCTR2007-002589-37-BE (EUCTR) | 10/04/2008 | 30/01/2008 | Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated inStudy SL0007. | Systemic Lupus Erythematosus MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 203 | Phase 2 | Hungary;Hong Kong;Brazil;Spain;Poland;Belgium;Ukraine;Lithuania;United Kingdom;India | ||
| 29 | EUCTR2007-002589-37-LT (EUCTR) | 02/04/2008 | 08/01/2008 | Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | Systemic Lupus Erythematosus MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | India;Hungary;United Kingdom;Ukraine;Belgium;Spain;Hong Kong;Poland;Brazil;Lithuania | ||
| 30 | EUCTR2007-002589-37-ES (EUCTR) | 26/03/2008 | 07/02/2008 | Estudio en fase IIb de seguimiento abierto, multicéntrico para evaluar la seguridad y la eficacia del epratuzumab en pacientes con lupus eritematoso sistémico activo con serología positiva que participaron en el estudio SL0007A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | Estudio en fase IIb de seguimiento abierto, multicéntrico para evaluar la seguridad y la eficacia del epratuzumab en pacientes con lupus eritematoso sistémico activo con serología positiva que participaron en el estudio SL0007A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | Lupus eritematoso sistémicosystemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | Hungary;Belgium;Spain;Lithuania;United Kingdom | ||
| 31 | EUCTR2007-002566-35-GB (EUCTR) | 19/03/2008 | 29/11/2007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 32 | EUCTR2007-002566-35-BE (EUCTR) | 25/02/2008 | 03/12/2007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania | ||
| 33 | EUCTR2007-002566-35-ES (EUCTR) | 14/02/2008 | 20/12/2007 | Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | Lupus eritematoso sistémicosystemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;Belgium;Spain;Lithuania;United Kingdom | ||
| 34 | EUCTR2007-002566-35-LT (EUCTR) | 11/02/2008 | 04/12/2007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2 | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Hungary;United Kingdom;Belgium;Spain;Lithuania |