Decortin 5 mg ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病6

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
1EUCTR2010-020137-10-LT
(EUCTR)
13/05/201512/03/2015Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
2EUCTR2010-020137-10-HU
(EUCTR)
12/01/201222/11/2011Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden
3EUCTR2010-020137-10-BE
(EUCTR)
23/03/201104/10/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
4EUCTR2010-020137-10-CZ
(EUCTR)
08/11/201004/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
5EUCTR2010-020137-10-IT
(EUCTR)
07/11/201008/11/2010An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALMAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM Crohn`s disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401
Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Trade Name: Azathioprin-ratiopharm 25 mg
INN or Proposed INN: Azathioprine
Trade Name: Azathioprine - ratiopharm 50 mg
INN or Proposed INN: Azathioprine
Trade Name: Decortin 5 mg
INN or Proposed INN: Prednisone
Trade Name: Decortin 20 mg
INN or Proposed INN: Prednisone
Abbott GmBH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
6EUCTR2010-020137-10-AT
(EUCTR)
16/09/201011/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden