106. クリオピリン関連周期熱症候群 Cryopyrin-associated periodic syndrome Clinical trials / Disease details
臨床試験数 : 42 / 薬物数 : 24 - (DrugBank : 4) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 48
| 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 | EUCTR2007-004367-22-BE (EUCTR) | 16/10/2009 | 21/08/2009 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 | The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab (WHO approval pending) 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 | 80 | France;Spain;Belgium;Germany;Italy;United Kingdom | |||
| 2 | EUCTR2007-004367-22-FR (EUCTR) | 18/06/2008 | 03/04/2008 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease. - D2306 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease. - D2306 | The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab (WHO approval pending) 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 | 80 | France;Belgium;Spain;Germany;Italy;United Kingdom | |||
| 3 | EUCTR2007-004367-22-DE (EUCTR) | 02/06/2008 | 13/03/2008 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 | The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome | Product Code: ACZ885 INN or Proposed INN: Canakinumab (WHO approval pending) 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 | 80 | United Kingdom;Germany;France;Spain;Italy | |||
| 4 | EUCTR2007-004367-22-GB (EUCTR) | 01/05/2008 | 07/03/2008 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease - D2306 | An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease - D2306 | The following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab (WHO approval pending) 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 | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Germany;Italy;United Kingdom |