Abatacept for IgG4-related disease

Inclusion criteria

• {"criterion_text":"- Male or female subjects of legal age and able to provide informed consent"}
• {"criterion_text":"- Patients with active IgG4-related disease naive to therapy or relapsing with an IgG4- RD RI > 2"}
• {"criterion_text":"- Achievement of the 2019 ACR/EULAR Classification Criteria of IgG4-related disease."}

Exclusion criteria

• {"criterion_text":"- Malignancy within 5 years"}
• {"criterion_text":"- Chronic or history of recurrent infections over 6 months prior to screening"}
• {"criterion_text":"- Evidence of severe active liver disease unrelated to IgG4RD"}
• {"criterion_text":"- Concomitant uncontrolled disease that would interfere with the study procedures"}
• {"criterion_text":"- Positive HIV, HBV, HCV serology"}
• {"criterion_text":"- Positive quantiferon test"}
• {"criterion_text":"- Inability to be tapered of glucocorticoid therapy by 8 weeks post randomisation"}
• {"criterion_text":"- Prior use of B cell depleting agents within 6 months of enrolment"}
• {"criterion_text":"- Leukopenia, neutropenia, thrombocytopenia, or anemia"}
• {"criterion_text":"- Serum creatinine > 2.0 mg/dL at the time of randomisation."}
• {"criterion_text":"- Positive pregnancy test at screening or during the study, or breast feeding"}
• {"criterion_text":"- Subjects who do not agree to use methods of contraception."}

Primary endpoints

• {"endpoint_text":"- Reduction of disease recurrence in patients with IgG4-related disease treated with abatacept compared with placebo-treated pazineti","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

21-03-2024

Latest Decision Or Authorization Date

16-04-2024

Processing Time Days

26

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy