331. 特発性多中心性キャッスルマン病 Idiopathic multicentric castleman disease Clinical trials / Disease details
臨床試験数 : 33 / 薬物数 : 46 - (DrugBank : 25) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 155
| 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 | EUCTR2009-012380-34-GB (EUCTR) | 18/05/2010 | 24/09/2009 | A study of the safety and efficacy of CNTO328 in combination with best supportive care compared to best supportive care in patients with Multicentric Castleman's Disease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman’s Disease | Multicentric Castleman's disease MedDRA version: 14.1;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hong Kong;Taiwan;Spain;Israel;Russian Federation;United Kingdom;India;France;Egypt;Hungary;Canada;Malaysia;Belgium;Brazil;Singapore;Australia;Netherlands;Germany;Norway;New Zealand;China;Korea, Republic of | ||
| 2 | EUCTR2009-012380-34-NL (EUCTR) | 23/03/2010 | 21/10/2009 | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive CareCompared With Best Supportive Care in Subjects With Multicentric Castleman’sDisease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive CareCompared With Best Supportive Care in Subjects With Multicentric Castleman’sDisease | Multicentric Castleman's disease MedDRA version: 13.1;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | France;Hungary;Spain;Belgium;Germany;Netherlands;United Kingdom | ||
| 3 | EUCTR2009-012380-34-HU (EUCTR) | 18/03/2010 | 15/12/2009 | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive CareCompared With Best Supportive Care in Subjects With Multicentric Castleman’sDisease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive CareCompared With Best Supportive Care in Subjects With Multicentric Castleman’sDisease | Multicentric Castleman's disease MedDRA version: 13.1;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 78 | Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Spain | |||
| 4 | NCT01024036 (ClinicalTrials.gov) | March 18, 2010 | 30/11/2009 | A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease | A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti IL 6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease | Multicentric Castleman's Disease | Drug: Siltuximab;Drug: Placebo;Drug: Best Supportive Care (BSC) | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 79 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;China;Egypt;France;Germany;Hong Kong;Hungary;India;Israel;Korea, Republic of;Malaysia;Netherlands;New Zealand;Norway;Russian Federation;Singapore;Spain;Taiwan;United Kingdom;Jordan;Poland |
| 5 | EUCTR2009-012380-34-DE (EUCTR) | 27/01/2010 | 15/10/2009 | A study of the safety and efficacy of CNTO 328 in combination with best supportive care compared to best supportive care in patients with Multicentric Castleman's Disease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman’s Disease | Multicentric Castleman's disease MedDRA version: 14.1;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 75 | United Kingdom;France;Hungary;Spain;Belgium;Netherlands;Germany | |||
| 6 | EUCTR2009-012380-34-BE (EUCTR) | 26/01/2010 | 05/10/2009 | A study of the safety and efficacy of CNTO 328 in combination with best supportive care compared to best supportive care in patients with Multicentric Castleman's Disease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman’s Disease | Multicentric Castleman's disease MedDRA version: 14.1;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Hong Kong;United States;Taiwan;Israel;Russian Federation;United Kingdom;India;France;Egypt;Hungary;Canada;Malaysia;Belgium;Brazil;Singapore;Australia;Netherlands;Germany;Norway;New Zealand;China;Korea, Republic of;Spain | ||
| 7 | EUCTR2009-012380-34-FR (EUCTR) | 21/01/2010 | 16/10/2009 | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive CareCompared With Best Supportive Care in Subjects With Multicentric Castleman’sDisease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive CareCompared With Best Supportive Care in Subjects With Multicentric Castleman’sDisease | Multicentric Castleman's disease MedDRA version: 12.0;Level: LLT;Classification code 10050251;Term: Castleman's disease | Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;Hungary;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 8 | EUCTR2009-012380-34-ES (EUCTR) | 21/12/2009 | 08/10/2009 | Estudio aleatorizado, doble ciego, controlado con placebo para valorar la eficacia y seguridad de CNTO 328 (anticuerpo monoclonal anti-IL-6) junto con la mejor terapia de soporte comparado con la mejor terapia de soporte, en sujetos con enfermedad de Castleman multicéntrica.A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman?sDisease | Estudio aleatorizado, doble ciego, controlado con placebo para valorar la eficacia y seguridad de CNTO 328 (anticuerpo monoclonal anti-IL-6) junto con la mejor terapia de soporte comparado con la mejor terapia de soporte, en sujetos con enfermedad de Castleman multicéntrica.A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy andSafety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman?sDisease | enfermedad de Castleman multicéntrica MedDRA version: 12.0;Level: LLT;Classification code 10050251;Term: Castleman's disease | Product Name: CNTO328 Product Code: CNTO328 INN or Proposed INN: NA Other descriptive name: Chimeric murine human anti-IL-6 monoclonal antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;Hungary;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 9 | NCT00412321 (ClinicalTrials.gov) | May 2005 | 15/12/2006 | A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease | A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease | Lymphoma, Non-Hodgkin;Multiple Myeloma;Giant Lymph Node Hyperplasia | Drug: CNTO 328 | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 67 | Phase 1 | United States |