DDrare: Database of Drug Development for Rare Diseases

266. 家族性地中海熱
［臨床試験数：27，薬物数：23（DrugBank：6），標的遺伝子数：14，標的パスウェイ数：57］

Searched query = "Familial mediterranean fever"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.9% physiological saline; ACZ885; ACZ885, 150mg/1.0ml; CANAKINUMAB; Canakinumab; Colchicine; Colchicine sprinkle capsules; Diagnostic Test: colchicine level measurement; IL-1 Trap; INN-Tocilizumab; Ilaris; Kineret; One additional blood sample during a planned blood test; Other: Colchicine Cessation; Other: Wheat flour; Probiotic; Rilonacept; RoActemra; RoActemra® 20mg/ml Konzentrat; TOCILIZUMAB; Tocilizumab; Tocilizumab Infusion RoAcemtra (EU); Wheat

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2013-004291-35-DE (EUCTR)	18/06/2014	14/04/2014	Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers	A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs	Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885, 150mg/1.0ml INN or Proposed INN: CANAKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan

No.

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Public_title

Scientific_title

Condition

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agemin

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EUCTR2013-004291-35-DE
(EUCTR)

18/06/2014

14/04/2014

Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs

Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885, 150mg/1.0ml
INN or Proposed INN: CANAKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan