D.3.6.2.1 - valore: 45 / 0.45 mg/ml ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎1

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004496-31-IT
(EUCTR)
18/02/201917/06/2021A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Golimumab
Product Code: [CNTO148]
INN or Proposed INN: GOLIMUMAB
Trade Name: SIMPONI
Product Name: Golimumab
Product Code: [CNTO148]
INN or Proposed INN: GOLIMUMAB
Other descriptive name: D.3.6.2.1 - valore: 45 / 0.45 mg/ml
Trade Name: Simponi
Product Name: Golimumab
Product Code: [CNTO148]
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: [CNTO312]
INN or Proposed INN: INFLIXIMAB
Other descriptive name: D.3.6.2.1 - valore: 5 o 10 mg/kg
Janssen Biologics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 3France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of