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. | 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 | EUCTR2010-020061-24-GB (EUCTR) | 15/11/2010 | 18/06/2010 | 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 AG | NULL | Not 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): no | Ireland;Italy;United Kingdom | ||
| 2 | EUCTR2010-020061-24-IT (EUCTR) | 20/09/2010 | 05/07/2010 | An 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 | An 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 50 | Ireland;United Kingdom;Italy | |||
| 3 | EUCTR2010-020061-24-IE (EUCTR) | 24/08/2010 | 18/05/2010 | ?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 AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Ireland;Italy;United Kingdom | |||
| 4 | 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] | Trade Name: Ilaris INN or Proposed INN: CANAKINUMAB | Novartis pharma AG | NULL | NA | Female: yes Male: yes | 4 | Phase 3 | Japan |