PredniSONE Tablets USP, 1mg ( DrugBank: Prednisone )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
41巨細胞性動脈炎1

41. 巨細胞性動脈炎


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004809-31-BG
(EUCTR)
08/11/202126/08/2021Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA).A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx 300mg solution for injection in pre-filled syringe
INN or Proposed INN: SECUKINUMAB
Trade Name: PredniSONE Tablets USP, 1mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 20mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden