108. TNF受容体関連周期性症候群 TNF receptor-associated periodic syndrome Clinical trials / Disease details


臨床試験数 : 4 薬物数 : 7 - (DrugBank : 1) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 44

  
No.TrialIDDate_
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PhaseCountries
1EUCTR2010-020061-24-GB
(EUCTR)
15/11/201018/06/2010 An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long term treatment period in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - D2203 An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long term treatment period in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - D2203 TNF-receptor associated periodic syndrome (TRAPS)
MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 100000004850
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noIreland;Italy;United Kingdom
2EUCTR2010-020061-24-IT
(EUCTR)
20/09/201005/07/2010An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 6-month follow-up in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - NDAn open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 6-month follow-up in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - ND Active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10034533;Term: Periodic fever
Product Name: canakinumab
Product Code: ACZ885D
INN or Proposed INN: Canakinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
50Ireland;United Kingdom;Italy
3EUCTR2010-020061-24-IE
(EUCTR)
24/08/201018/05/2010?A study to check how beneficial and safe the drug canakinumab is for patients with TNF-receptor associated periodic syndrome (TRAPS)An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long-term treatment period in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - D2203 TNF-receptor associated periodic syndrome (TRAPS)
MedDRA version: 14.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic 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
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
20Ireland;Italy;United Kingdom
4EUCTR2017-001678-40-Outside-EU/EEA
(EUCTR)
15/05/2017An extension study of safety of canakinumab in Japanese patients with periodic fever syndromesAn extension study of safety of canakinumab in Japanese patients with periodic fever syndromes Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ilaris
INN or Proposed INN: CANAKINUMAB
Novartis pharma AGNULLNAFemale: yes
Male: yes
4Phase 3Japan