266. 家族性地中海熱 Familial mediterranean fever Clinical trials / Disease details
臨床試験数 : 28 / 薬物数 : 24 - (DrugBank : 6) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 59
Showing 1 to 7 of 7 diseases
| 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-NL (EUCTR) | 07/10/2014 | 24/07/2014 | 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 A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Peri ... | 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] Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 19.0;Level: PT;Classification cod ... | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United ... | ||
| 2 | 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 A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Peri ... | 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] Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 19.0;Level: PT;Classification cod ... | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885, 150mg/1.0ml INN or Proposed INN: CANAKINUMAB Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885, 150mg/1.0ml INN or Proposed INN: CAN ... | 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 United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom ... | ||
| 3 | EUCTR2013-004291-35-IT (EUCTR) | 16/05/2014 | 20/03/2014 | 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 A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Peri ... | Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;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] Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 16.1;Level: LLT;Classification co ... | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Farma SpA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Swi ... | ||
| 4 | EUCTR2013-004291-35-ES (EUCTR) | 14/05/2014 | 04/04/2014 | 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 A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Peri ... | Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;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] Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) MedDRA version: 16.1;Level: LLT;Classification co ... | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Swi ... | ||
| 5 | EUCTR2017-001678-40-Outside-EU/EEA (EUCTR) | 15/05/2017 | An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes | An 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] Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper ... | Trade Name: Ilaris INN or Proposed INN: CANAKINUMAB | Novartis pharma AG | NULL | NA | Female: yes Male: yes | 4 | Phase 3 | Japan | |||
| 6 | EUCTR2015-003522-13-Outside-EU/EEA (EUCTR) | 14/04/2016 | Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF) Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or ... | A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of ... | Colchicine Resistant/Intolerant Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Colchicine Resistant/Intolerant Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classifi ... | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharmaceuticals | NULL | NA | Female: yes Male: yes | 15 | Phase 2 | Israel | |||
| 7 | EUCTR2015-003527-57-Outside-EU/EEA (EUCTR) | 14/04/2016 | Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Feve ... | An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Can ... | Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Famil ... | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharmaceuticals | NULL | NA | Female: yes Male: yes | 9 | Turkey |