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 | EUCTR2004-002980-26-FR (EUCTR) | 07/06/2007 | 29/03/2007 | An open-label, phase II dose titration study of ACZ885 (human anti-IL-1beta monoclonal antibody) to assess the clinical efficacy, safety, pharmacokinetics and pharmacodynamics in patients with NALP3 mutations - A2102 | An open-label, phase II dose titration study of ACZ885 (human anti-IL-1beta monoclonal antibody) to assess the clinical efficacy, safety, pharmacokinetics and pharmacodynamics in patients with NALP3 mutations - A2102 | Muckle-Wells Syndrome: rare hereditary, autosomal dominant, systemic inflammatory disease, characterized by recurrent episodes of fever, arthralgia, myalgia, urticarial rash, and conjunctivitis. Laboratory findings show an elevation of acute phase proteins such as CRP and SAA, a high ESR, together with leukocytosis, and hypergammaglobulinemia. Severe long term complications include progressive sensorineural deafness, and systemic AA amyloidosis. MedDRA version: 9.1;Level: LLT;Classification code 10064573;Term: Neonatal-onset multisystemic inflammatory disease MedDRA version: 9.1;Classification code 10064570;Term: Familial cold autoinflammatory syndrome | Product Code: ACZ885 Other descriptive name: ACZ885 drug substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;Spain;Germany;United Kingdom |