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 | EUCTR2008-004852-62-IT (EUCTR) | 09/02/2009 | 27/01/2009 | Safety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITIS | Safety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITIS | MedDRA version: 9.1;Level: SOC;Classification code 10028395 MedDRA version: 9.1;Level: LLT;Classification code 10040970 | Product Name: ABETIMUS SODIUM Product Code: LJP394 INN or Proposed INN: RIQUENT | AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 2 | EUCTR2006-000674-73-BG (EUCTR) | 14/08/2008 | 14/08/2008 | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus Sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium Other descriptive name: RIQUENT | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 3 | EUCTR2006-000674-73-IT (EUCTR) | 12/05/2008 | 20/03/2008 | A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND | A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND | Systemic lupus erithematosus (SLE) patients with a history of renal disease. MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus | LA JOLLA PHARMACEUTICAL COMPANY | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 4 | EUCTR2006-000674-73-ES (EUCTR) | 21/02/2008 | 03/12/2007 | ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA | ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 5 | EUCTR2006-000674-73-DE (EUCTR) | 23/01/2008 | 16/10/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 850 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 6 | EUCTR2006-000674-73-PT (EUCTR) | 11/01/2008 | 17/09/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Czech Republic;Hungary;Spain;Bulgaria;Germany;Italy | |||
| 7 | EUCTR2006-000674-73-CZ (EUCTR) | 07/01/2008 | 25/10/2007 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 730 | Portugal;Hungary;Germany;Czech Republic;Bulgaria;Spain;Italy | |||
| 8 | EUCTR2006-000674-73-SK (EUCTR) | 09/10/2006 | 09/08/2006 | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Not Recruiting | Female: yes Male: yes | 588 | Phase 3 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Bulgaria;Germany;Italy | ||
| 9 | NCT00390091 (ClinicalTrials.gov) | September 2006 | 17/10/2006 | Study of LJP 394 (Abetimus Sodium) in Lupus Patients | A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: abetimus sodium (LJP 394) | La Jolla Pharmaceutical Company | NULL | Withdrawn | 12 Years | 70 Years | Both | 0 | Phase 2 | United States |
| 10 | EUCTR2006-000674-73-HU (EUCTR) | 11/08/2006 | 15/06/2006 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium | La Jolla Pharmaceutical Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | |||
| 11 | NCT00089804 (ClinicalTrials.gov) | October 2004 | 13/8/2004 | Study of LJP 394 in Lupus Patients With History of Renal Disease | A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease | Lupus Erythematosus, Systemic;Lupus Nephritis | Drug: abetimus sodium (LJP 394) and/or placebo solution;Drug: abetimus sodium (LJP 394);Drug: Phosphate-buffered saline | La Jolla Pharmaceutical Company | NULL | Terminated | 12 Years | 70 Years | Both | 943 | Phase 3 | United States;Argentina;Australia;Belarus;Brazil;Bulgaria;Czech Republic;Georgia;Germany;Hong Kong;Hungary;India;Indonesia;Italy;Korea, Republic of;Lebanon;Malaysia;Mexico;Philippines;Poland;Portugal;Puerto Rico;Romania;Serbia;Slovakia;Spain;Sri Lanka;Taiwan;Thailand;Ukraine;Former Serbia and Montenegro |
| 12 | NCT00035308 (ClinicalTrials.gov) | November 2001 | 2/5/2002 | Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease | Immunologic Diseases;Autoimmune Diseases;Systemic Lupus Erythematosus;Lupus Nephritis;Lupus Glomerulonephritis | Drug: Abetimus sodium (LJP 394) | La Jolla Pharmaceutical Company | NULL | Completed | 12 Years | 70 Years | Both | 330 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Mexico;Spain;Sweden;United Kingdom |