Anti-Interleukin-6 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2
96クローン病7

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
1EUCTR2010-023956-99-NL
(EUCTR)
28/07/201130/05/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Protocol Amendment 03 (v1.0, dated 08-Mar-2011) RHEUMATOID ARTHRITIS,NOS
MedDRA version: 13.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: BMS-945429
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
677Phase 2United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of
2EUCTR2010-023956-99-ES
(EUCTR)
20/07/201103/11/2011Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to MethotrexateA Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011) - RHEUMATOID ARTHRITIS,NOS
MedDRA version: 14.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: BMS-945429
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
677Phase 2Hungary;Germany;Netherlands;France;Italy;South Africa;Brazil;Russian Federation;Czech Republic;Canada;Peru;Taiwan;Argentina;Belgium;Mexico;Korea, Republic of;Spain;Japan;United States

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004763-72-NL
(EUCTR)
04/10/201230/05/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Germany;Netherlands;Korea, Republic of
2EUCTR2011-004763-72-GB
(EUCTR)
13/09/201225/06/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01+ UK-specific Amendment 04 (dated 23-Apr-12) Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Hong Kong;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
3EUCTR2011-004763-72-IT
(EUCTR)
16/07/201203/09/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12) Crohn’s Disease
MedDRA version: 15.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
Other descriptive name: anti-IL-6 mAb
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;India;Czech Republic;Hungary;European Union;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
4EUCTR2011-004763-72-CZ
(EUCTR)
11/07/201221/05/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of;United States
5EUCTR2011-004763-72-DE
(EUCTR)
04/07/201227/04/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12);Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
6EUCTR2011-004763-72-HU
(EUCTR)
26/06/201226/04/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
7EUCTR2011-004763-72-AT
(EUCTR)
25/05/201227/04/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of