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Abatacept for therapy of IgG4-related disease
EU CTIS ID: 2024-512863-30-00
What this study is testing
To demonstrate the efficacy of abatacept in reducing the risk of disease recurrence at 48 weeks
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.