Abatacept for therapy of IgG4-related disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 32

Inclusion Criteria

1. Male or female subjects of legal age and able to provide informed consent
2. Patients with active IgG4-related disease naive to therapy or relapsing with an IgG4-RD RI > 2
3. Achievement of the 2019 ACR/EULAR Classification Criteria of IgG4-related disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

- Malignancy within 5 years
- 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
- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of abatacept in reducing the risk of disease recurrence at 48 weeks;Secondary Objective: - To evaluate the safety and tolerability of abatacept in patients with IgG4-related disease<br>- To study the effects of abatacept on the following measures of disease activity: time to relapse, complete remission, clinical response, IgG4-related disease responder index (IgG4RD-RI), Physician Global Assessment, cumulative steroid dose, soluble biomarkers of B- and T cell activation, transcriptome, selective efficacy in one of the 4 disease phenotypes.;Primary end point(s): Reduction of disease recurrence in patients with IgG4-related disease treated with abatacept compared with placebo-treated pazineti;Timepoint(s) of evaluation of this end point: Monthly, up to 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - time to recurrence<br>- complete remission rate<br>- clinical response rate<br>- impact on IgG4-related disease responder index (IgG4RD-RI)<br>- Physician Global Assessment<br>- cumulative steroid dose,<br>- soluble biomarkers of B and T cell activation, transcriptome<br>- selective efficacy in one of the 4 disease phenotypes.;Timepoint(s) of evaluation of this end point: Monthly, up to 12 months

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