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 | NCT02306629 (ClinicalTrials.gov) | November 2014 | 29/11/2014 | Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood | An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects | Systemic Lupus Erythematosus | Biological: Epratuzumab sc;Biological: Epratuzumab iv | UCB Biopharma S.P.R.L. | Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors Laboratory | Completed | 18 Years | 50 Years | Both | 42 | Phase 1 | United Kingdom |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | NCT01534403 (ClinicalTrials.gov) | January 2012 | 13/2/2012 | Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects | A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | 65 Years | Both | 17 | Phase 2 | Japan |
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | NCT01449071 (ClinicalTrials.gov) | October 2011 | 3/10/2011 | Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) | A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease | Systemic Lupus Erythematosus | Biological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mg | UCB Pharma | NULL | Completed | 18 Years | 64 Years | Both | 20 | Phase 1/Phase 2 | Japan |
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | NCT01408576 (ClinicalTrials.gov) | July 2011 | 1/8/2011 | Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus | A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects | Systemic Lupus Erythematosus | Drug: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 1250 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic |
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | |||
| 25 | 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 | |||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | NCT01262365 (ClinicalTrials.gov) | December 2010 | 14/12/2010 | Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus | 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 | Systemic Lupus Erythematosus | Drug: Epratuzumab;Drug: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 793 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Czechia;Estonia;France;Germany;India;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;United Kingdom;Czech Republic |
| 30 | NCT01261793 (ClinicalTrials.gov) | December 2010 | 14/12/2010 | 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 | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 791 | Phase 3 | United States;Brazil;Canada;France;Germany;Hungary;India;Italy;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Netherlands |
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | NCT00660881 (ClinicalTrials.gov) | May 2008 | 15/4/2008 | 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 Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007 | Systemic Lupus Erythematosus | Biological: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 210 | Phase 2 | United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom |
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | 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 | ||
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | NCT00624351 (ClinicalTrials.gov) | January 2008 | 15/2/2008 | Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease | 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 (SLE) Patients With Active Disease | Systemic Lupus Erythematosus | Biological: Epratuzumab;Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 227 | Phase 2 | United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom |
| 43 | NCT00382837 (ClinicalTrials.gov) | January 2007 | 29/9/2006 | Study of Epratuzumab in Systemic Lupus Erythematosus | A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems | Systemic Lupus Erythematosus | Drug: Epratuzumab | UCB Pharma | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Italy;Netherlands;Slovakia;Spain;United Kingdom |
| 44 | NCT00383513 (ClinicalTrials.gov) | June 2006 | 29/9/2006 | Study of Epratuzumab in Systemic Lupus Erythematosus | An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 29 | Phase 2 | United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 45 | EUCTR2005-000705-59-DE (EUCTR) | 11/04/2006 | 07/06/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | UCB Pharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;United Kingdom;Germany;Spain;Italy | ||
| 46 | EUCTR2005-000705-59-HU (EUCTR) | 09/01/2006 | 12/10/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;Slovakia;Spain;Germany;Italy;United Kingdom | ||
| 47 | EUCTR2005-000706-31-DE (EUCTR) | 05/01/2006 | 28/06/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | UCB Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United Kingdom;Germany;Spain;Italy | ||
| 48 | EUCTR2005-000705-59-SK (EUCTR) | 14/10/2005 | 29/07/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;Slovakia;Spain;Germany;Italy;United Kingdom | ||
| 49 | EUCTR2005-000706-31-IT (EUCTR) | 15/09/2005 | 30/09/2005 | A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosus | A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosus | improvement of signs and symptoms of Active Systemic Lupus Erythematosus MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Epatuzumab Product Code: hLL2,IMMU-103 | IMMUNOMEDICS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany;United Kingdom;Spain;Italy | |||
| 50 | EUCTR2005-000706-31-ES (EUCTR) | 25/07/2005 | 23/05/2006 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 INN or Proposed INN: Epratuzumab Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Belgium;Spain;Germany;Italy;United Kingdom | ||
| 51 | EUCTR2005-000706-31-BE (EUCTR) | 29/06/2005 | 26/07/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | UCB Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Spain;Belgium;Germany;Italy;United Kingdom | ||
| 52 | EUCTR2005-000705-59-GB (EUCTR) | 07/06/2005 | 19/04/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy | ||
| 53 | NCT00111306 (ClinicalTrials.gov) | June 2005 | 19/5/2005 | Study of Epratuzumab in Systemic Lupus Erythematosus | A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems | Systemic Lupus Erythematosus | Drug: epratuzumab | UCB Pharma | NULL | Terminated | 18 Years | N/A | Both | 510 | Phase 3 | United States;Belgium;Hungary;Netherlands;Spain;United Kingdom |
| 54 | EUCTR2005-000706-31-GB (EUCTR) | 13/05/2005 | 19/04/2005 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) | Immunomedics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Germany;United Kingdom;Spain;Italy | ||
| 55 | NCT00383214 (ClinicalTrials.gov) | May 2005 | 29/9/2006 | Study of Epratuzumab in Systemic Lupus Erythematosus (SLE) | A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Drug: Epratuzumab;Other: Placebo | UCB Pharma | NULL | Terminated | 18 Years | N/A | Both | 54 | Phase 3 | United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 56 | NCT00113971 (ClinicalTrials.gov) | April 2005 | 10/6/2005 | Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE) | A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: epratuzumab | UCB Pharma | NULL | Terminated | 18 Years | N/A | Both | 20 | Phase 2 | United States |
| 57 | NCT00011908 (ClinicalTrials.gov) | February 2001 | 3/3/2001 | Humanized LL2IGG to Treat Systemic Lupus Erythematosus | A Phase I Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: hLL2 (Epratuzumab) | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Completed | N/A | N/A | Both | 20 | Phase 1 | United States |