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

  
1 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-002980-26-FR
(EUCTR)
07/06/200729/03/2007An 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 - A2102An 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 AGNULLNot RecruitingFemale: yes
Male: yes
34Phase 2France;Spain;Germany;United Kingdom