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Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.
Full description
Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.
This phase II open-label study has 2 mains objectives:
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Inclusion criteria
Objective sicca (positive oral and/or ocular tests reported in the American European Consensus Group Criteria) with at least one among the following biological features of serum B lymphocyte activation :
increased IgG levels increased free light chain levels of immunoglobulins (according to central laboratory ranges) increased serum beta2-microglobulin levels decreased C4 levels (C4 levels inferior to central laboratory ranges) monoclonal gammapathy cryoglobulinemia OR
SS of more recent onset, i.e., less than 5 years of duration of symptoms, associated with:
Exclusion criteria
Any BLyS-targeted (BLyS-receptor fusion protein [BR3], TACI Fc, or belimumab) at any time.
Any of the following within 364 days of Day 0:
4- Intravenous or oral cyclophosphamide within 180 days of Day 0.
5- Any of the following within 90 days of Day 0:
Anti-TNF therapy
Interleukin-1 receptor antagonist
Abatacept
Interleukin-6 receptor antagonist
Intravenous immunoglobulin
Prednisone > 100 mg/day
Plasmapheresis.
9- Very severe SS disease.
10- Major organ or hematopoietic stem cell/marrow transplant.
11- Unstable or uncontrolled acute or chronic diseases not due to SS
13- History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
14- Required management of acute or chronic infections, as follows:
Currently on any suppressive therapy for a chronic infection
Hospitalization for treatment of infection within 60 days of Day 0.
Use of parenteral (IV or IM) antibiotics
16- Historically or at screening positive test for HIV antibody, hepatitis C virus antibodies, or, hepatitis B surface antigen (HbsAg) (with or without positive serum HBV DNA), or antiHBcAg positivity (without anti-HbsAg positivity).
17- Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
Stable Grade 3/4 proteinuria (≤ 6 g/24 hour equivalent by spot urine protein to creatinine ratio allowed). (mentioned earlier in Exclusion #8)
Stable Grade 3 neutropenia or stable Grade 3 white blood cell count.
Primary purpose
Allocation
Interventional model
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20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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