JPRN-jRCTs071230067招募中4 期
Analysis of effectiveness of Ozoralizumab toward bone structure in rheumatoid arthritis - AOZORA study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)diagnosis of RA according to the American College of Rheumatology (ACR) RA Classification Criteria 1987 Revision or ACR/ European League Against Rheumatism (EULAR) 2010 RA Classification Criteria
- •2) age of 18 years or older
- •3) residual arthralgia during treatment with at least one csDMARD, including MTX
- •4) ability and willingness to provide written informed consent and comply with the requirements of the study protocol
- •5) Patients with a history of tuberculosis(TB) who have been confirmed free of active TB by a tuberculin reaction test or interferon gamma release assays in addition to a chest x-ray within the past year from the time of consent, or who are receiving appropriate antituberculosis drugs
- •6) Patients with moderate to high disease activity (DAS28-ESR>=3.2, DAS28-CRP>=2.7, SDAI>11, or CDAI>10) and joint destruction (joint space narrowing or bone erosion by either X-ray, MRI, or joint ultrasound)
排除标准
- •1)Pregnant women or patients who may be pregnant.
- •2)the concurrent use of a corticosteroid equivalent to >10 mg/day of prednisolone
- •3) intra-articular injection of steroids into the joint being evaluated (2, 3 metacarpophalangeal(MCP) joints of both fingers and both wrist joints) within the last 6 months of obtaining consent
- •4)current use of denosumab, parathyroid hormone agonist and anti-sclerostin antibody
- •5)severe infection
- •6)active tuberculosis
- •7)Current and history of demyelinating disease
- •8)Current congestive heart failure
- •9)History of hypersensitivity to components of ozoralizumab
- •10)History of ozoralizumab use
- •11) Patients under treatment with biological agents and JAK inhibitors for RA, except for denosumab.
- •12)Patients with a history of tuberculosis who have not been confirmed to be free of active tuberculosis by a tuberculin reaction test or interferon gamma release assays in addition to a chest x-ray within the past year from the time of obtaining consent
- •13)Defects in the evaluated joints (2,3 MCP joints of both fingers and both wrist joints) or deformities due to previous surgical operations
- •14)inappropriateness for inclusion in this study as determined by the investigators.
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