jRCTs071230067进行中（未招募）不适用
Analysis of effectiveness of Ozoralizumab toward bone structure in rheumatoid arthritis (AOZORA study)
未提供0 个研究点目标入组 40 人开始时间: 2023年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 主要终点
- Volumetric change in bone erosions
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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
- •age of 18 years or older
- •residual arthralgia during treatment with at least one csDMARD, including MTX
- •ability and willingness to provide written informed consent and comply with the requirements of the study protocol
- •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
- •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
- •Pregnant women or patients who may be pregnant.
- •the concurrent use of a corticosteroid equivalent to >10 mg/day of prednisolone
- •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
- •current use of denosumab, parathyroid hormone agonist and anti-sclerostin antibody
- •severe infection
- •active tuberculosis
- •Current and history of demyelinating disease
- •Current congestive heart failure
- •History of hypersensitivity to components of ozoralizumab
- •History of ozoralizumab use
- •Patients under treatment with biological agents and JAK inhibitors for RA, except for denosumab.
- •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
- •Defects in the evaluated joints (2,3 MCP joints of both fingers and both wrist joints) or deformities due to previous surgical operations
- •inappropriateness for inclusion in this study as determined by the investigators.
结局指标
主要结局
Volumetric change in bone erosions
时间窗: 52 weeks
Detected by HR-pQCT at 52 weeks in the ozoralizumab group and the historical control group per evaluated joint compared to baseline (screening period)
次要结局
- Evaluate each parameter and other imaging studies
- Disease activity
研究者
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