A pilot evaluation of safety and efficacy of usutekinumab in Takayasu arteritis

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: Subcutaneous injection of usutekinumab (45 mg/body, 0 and 4th week) CONDITION: Takayasu arteritis PRIMARY OUTCOME: 1. Safety; a) Serious adverse events (anaphylaxis, hypotension, angioedema and serious viral/bacterial/fungal infections such as tuberculosis, cellulitis, diverticulitis, osteomyelitis, gastroenteritis, pneumonia and urinary tract infection); b) Symptoms related with adverse events (skin rash, sore throat, cough, sputum, dyspnea on efforts, chest pain, chest tightness, nausea, abdominal pain, diarrhea and frequent urination); c) Abnormal data in general laboratory tests (Complete blood count, biochemical examination); 2. Efficacy; a) Improved visual analogue scales (headache, neck pain, easy fatigability of arms, easy fatigability of body, muscle pain); b) Improved biomarkers (CRP, ESR, matrix metalloproteinase‐9); c) Improved findings in images (MR angiography, carotid artery US) INCLUSION CRITERIA: 1) A case who was diagnosed as having Takayasu arteritis using the classification criteria (2006‐2007) of Ministry of Health, Labour and Welfare, Japan and who is attending to Department of Rheumatology and Clinical Immunology, Kyoto University Hospital 2) A case who has either an HLA‐B*52:01 allele or a risk allele of IL‐12B SNPs 3) A case with uncontrolled or recurrent symptoms such as fever, neck pain, headache and easy fatigability even after use of glucocorticoids and immunosuppressive agents
Epistemonikos ID: bb47c758cd2dfc394f4d212d6eee049093914658
First added on: Aug 22, 2024