Abatacept for therapy of IgG4-related disease
- Conditions
- IgG4-related diseaseTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-512863-30-00
- Lead Sponsor
- Ospedale San Raffaele S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
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.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method