Human anti TNF-alpha monoclonal antibody ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ4
84サルコイドーシス6

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-010582-23-BE
(EUCTR)
10/02/201023/09/2009Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
2EUCTR2009-010582-23-DE
(EUCTR)
04/01/201022/09/2009A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
3EUCTR2009-010582-23-GB
(EUCTR)
31/12/200928/06/2010Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab prefilled pen or prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGreece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden
4EUCTR2009-010582-23-SE
(EUCTR)
16/12/200923/10/2009A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-010714-30-NL
(EUCTR)
22/12/200903/02/2011A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis - Chronic sarcoidosis
MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: human anti TNF-alpha monoclonal antibody
Product Name: ustekinumab liquid in prefilled syringe
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: human anti-IL 12/23 monoclonal antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Italy
2EUCTR2009-010714-30-FR
(EUCTR)
10/11/200915/10/2009A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic SarcoidosisA Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis Chronic sarcoidosis
MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: human anti TNF-alpha monoclonal antibody
Product Name: ustekinumab liquid in prefilled syringe
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: human anti-IL 12/23 monoclonal antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom
3EUCTR2009-010714-30-DE
(EUCTR)
23/10/200908/07/2009A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic SarcoidosisA Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis Chronic sarcoidosis
MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: human anti TNF-alpha monoclonal antibody
Product Name: ustekinumab liquid in prefilled syringe
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: human anti-IL 12/23 monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom
4EUCTR2009-010714-30-DK
(EUCTR)
12/10/200917/08/2009A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with SarcoidosisA Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis Chronic sarcoidosis
MedDRA version: 14.0;Level: PT;Classification code 10039486;Term: Sarcoidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: human anti TNF-alpha monoclonal antibody
Product Name: ustekinumab liquid in prefilled syringe
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: human anti-IL 12/23 monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Belgium;Romania;Denmark;Netherlands;Germany;Italy;United Kingdom
5EUCTR2009-010714-30-BE
(EUCTR)
28/09/200908/07/2009A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with SarcoidosisA Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis Chronic sarcoidosis
MedDRA version: 13.1;Level: PT;Classification code 10039486;Term: Sarcoidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: ustekinumab liquid in prefilled syringe
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: Human anti-IL 12/23 monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Belgium;Denmark;Germany;Norway;Netherlands;Italy;United Kingdom
6EUCTR2009-010714-30-GB
(EUCTR)
14/09/200920/07/2009A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic SarcoidosisA Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis Chronic sarcoidosis
MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: human anti TNF-alpha monoclonal antibody
Product Name: ustekinumab liquid in prefilled syringe
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: human anti-IL 12/23 monoclonal antibody
Janssen Biologics B.V.NULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom