Takayasu arteritis
Conditions
Interventions
Subcutaneous injection of usutekinumab (45 mg/body, 0 and 4th week)
Sponsors
Department of Rheumatology and Clinical Immunology Graduate School of Medicine, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1) A case who is suspected of having active or latent tuberculosis or of type B hepatitis by the results of a tuberculin test, chest X-ray or laboratory tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactHajime Yoshifuji
Graduate School of Medicine, Kyoto University Department of Rheumatology and Clinical Immunology
Outcome results
None listed