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

Phase 2

• Conditions: Takayasu arteritis

• Registration Number: JPRN-UMIN000011587
• Lead Sponsor: Department of Rheumatology and Clinical Immunology Graduate School of Medicine, Kyoto University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-01
• Study Completion: 2014-06-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)