49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | |||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 |