2024-512863-30-00招募中2 期
Deciphering B and T cell Co-stimulation for the Targeted Treatment of IgG4-Related Disease
Ospedale San Raffaele S.r.l., Ospedale San Raffaele S.r.l.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Reduction of disease recurrence in patients with IgG4-related disease treated with abatacept compared with placebo-treated pazineti
研究概览
简要总结
To demonstrate the efficacy of abatacept in reducing the risk of disease recurrence at 48 weeks
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of legal age and able to provide informed consent
- •Patients with active IgG4-related disease naive to therapy or relapsing with an IgG4- RD RI > 2
- •Achievement of the 2019 ACR/EULAR Classification Criteria of IgG4-related disease.
排除标准
- •Malignancy within 5 years
- •Serum creatinine > 2.0 mg/dL at the time of randomisation.
- •Positive pregnancy test at screening or during the study, or breast feeding
- •Subjects who do not agree to use methods of contraception.
- •Chronic or history of recurrent infections over 6 months prior to screening
- •Evidence of severe active liver disease unrelated to IgG4RD
- •Concomitant uncontrolled disease that would interfere with the study procedures
- •Positive HIV, HBV, HCV serology
- •Positive quantiferon test
- •Inability to be tapered of glucocorticoid therapy by 8 weeks post randomisation
- •Prior use of B cell depleting agents within 6 months of enrolment
- •Leukopenia, neutropenia, thrombocytopenia, or anemia
结局指标
主要结局
Reduction of disease recurrence in patients with IgG4-related disease treated with abatacept compared with placebo-treated pazineti
Reduction of disease recurrence in patients with IgG4-related disease treated with abatacept compared with placebo-treated pazineti
次要结局
未报告次要终点
研究者
Emanuel Della Torre
Scientific
Ospedale San Raffaele S.r.l.
研究点 (1)
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