Humira 40mg/0.4ml 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1

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
1EUCTR2016-000522-18-GB
(EUCTR)
28/03/201805/12/2017Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISKinCD-PIBD -TRIAL Paediatric Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40mg/0.4ml pre-filled syringe
Product Name: Humira 40mg/0.4ml pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SUB20016
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: Azathioprine
INN or Proposed INN: Azathioprine
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
INN or Proposed INN: Methotrexate
Product Name: Mercaptopurine
INN or Proposed INN: Mercaptopurine
Other descriptive name: 6-Mercaptopurine
PIBD netNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
312 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom