CNTO328 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
331特発性多中心性キャッスルマン病12

331. 特発性多中心性キャッスルマン病


臨床試験数 : 33 薬物数 : 41 - (DrugBank : 21) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-022837-27-GB
(EUCTR)
15/02/201301/08/2012A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseAn Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab 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) ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: CNTO328
Product Code: CNTO328
Other descriptive name: SILTUXIMAB
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hong Kong;Taiwan;Spain;Israel;United Kingdom;Egypt;France;Canada;Belgium;Brazil;Singapore;Germany;Norway;New Zealand;China;Korea, Republic of
2EUCTR2010-022837-27-BE
(EUCTR)
17/12/201223/07/2012A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseAn Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease Multicentric Castleman's Disease
MedDRA version: 17.0;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: CNTO328
Product Code: CNTO328
Other descriptive name: SILTUXIMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Taiwan;Hong Kong;Spain;Israel;United Kingdom;Egypt;France;Canada;Belgium;Brazil;Singapore;Norway;Germany;New Zealand;China;Korea, Republic of
3EUCTR2010-022837-27-ES
(EUCTR)
29/11/201226/09/2012A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseAn Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease Multicentric Castleman's Disease
MedDRA version: 15.0;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: CNTO328
Product Code: CNTO328
INN or Proposed INN: NA
Other descriptive name: SILTUXIMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Hong Kong;Taiwan;Spain;Israel;United Kingdom;Egypt;France;Canada;Belgium;Brazil;Singapore;Germany;Norway;New Zealand;China;Korea, Republic of
4EUCTR2010-022837-27-DE
(EUCTR)
21/11/201219/09/2012A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseAn Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease Multicentric Castleman's Disease
MedDRA version: 17.0;Level: PT;Classification code 10050251;Term: Castleman's disease;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: CNTO328
Product Code: CNTO328
Other descriptive name: SILTUXIMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Taiwan;Hong Kong;Spain;Israel;United Kingdom;Egypt;France;Canada;Belgium;Brazil;Singapore;Norway;Germany;New Zealand;China;Korea, Republic of
5EUCTR2009-012380-34-GB
(EUCTR)
18/05/201024/09/2009A 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 DiseaseA 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.NULLNot 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): noUnited 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
6EUCTR2009-012380-34-NL
(EUCTR)
23/03/201021/10/2009A 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’sDiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2France;Hungary;Spain;Belgium;Germany;Netherlands;United Kingdom
7EUCTR2009-012380-34-HU
(EUCTR)
18/03/201015/12/2009A 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’sDiseaseA 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 BVNULLNot RecruitingFemale: yes
Male: yes
78Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Spain
8NCT01024036
(ClinicalTrials.gov)
March 18, 201030/11/2009A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's DiseaseA 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 DiseaseMulticentric Castleman's DiseaseDrug: Siltuximab;Drug: Placebo;Drug: Best Supportive Care (BSC)Janssen Research & Development, LLCNULLCompleted18 YearsN/AAll79Phase 2United 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
9EUCTR2009-012380-34-DE
(EUCTR)
27/01/201015/10/2009A 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 DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
75United Kingdom;France;Hungary;Spain;Belgium;Netherlands;Germany
10EUCTR2009-012380-34-BE
(EUCTR)
26/01/201005/10/2009A 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 DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2Hong 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
11EUCTR2009-012380-34-FR
(EUCTR)
21/01/201016/10/2009A 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’sDiseaseA 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 BVNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;Hungary;Spain;Belgium;Netherlands;Germany;United Kingdom
12EUCTR2009-012380-34-ES
(EUCTR)
21/12/200908/10/2009Estudio 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?sDiseaseEstudio 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 BVNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;Hungary;Belgium;Spain;Netherlands;Germany;United Kingdom