Humira 20 mg solution for injection in pre-filled syringe ( 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3

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-006494-90-CZ
(EUCTR)
11/02/200907/11/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study 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]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Canada;Belgium;Poland;United Kingdom
2EUCTR2007-006494-90-BE
(EUCTR)
24/11/200818/08/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study 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
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
Abbvie Deutschland GmbH & Co. K.G.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United Kingdom;Belgium;United States;Czech Republic;Canada;Poland
3EUCTR2007-006494-90-Outside-EU/EEA
(EUCTR)
07/02/2012Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study 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]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
Abbott GmbH & Co. K.G.NULLNAFemale: yes
Male: yes
100Belgium;Canada;Czech Republic;Poland;United Kingdom;United States