IgG4-related disease MedDRA version: 21.1 Level: LLT Classification code 10071569 Term: Immunoglobulin G4 related sclerosing disease System Organ Class: 100000004859 MedDRA version: 21.1 Level: LLT Classification code 10071569 Term: Immunoglobulin G4 related sclerosing disease System Organ Class: 100000004859
Conditions
Interventions
Trade Name: ORENCIA
Product Name: Abatacept
Product Code: [Abatacept]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Current S
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - time to recurrence - complete remission rate - clinical response rate - impact on 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.;Timepoint(s) of evaluation of this end point: Monthly, up to 12 months | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
IRCSS Ospedale San Raffaele
Outcome results
None listed