跳至主要内容
临床试验/CTIS2024-512863-30-00
CTIS2024-512863-30-00进行中(未招募)1 期

Deciphering B and T cell Co-stimulation for the Targeted Treatment of IgG4-Related Disease

Ospedale San Raffaele S.r.l.0 个研究点目标入组 32 人开始时间: 2024年3月29日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
32

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

年龄范围
18 至 65+(—)
性别
All

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

研究者

发起方
Ospedale San Raffaele S.r.l.

相似试验