A Phase 2 interventional study of Belimumab in Sjögren's Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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.
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:
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 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:
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:
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:
Drug: Belimumab
Belimumab will be administered at 10 mg/kg at Days 0, 14, 28 and then every 28 days until week 24 for all patients and week 48 for those considered responders at week 28.
Also known as: HGS1006, LymphoStat-B™,, Human Monoclonal Anti-BLyS (BAFF) Antibody, Benlysta
response rate
A response is defined as the fulfilment of any 2 of the 5 following response criteria(values are compared to that of baseline \[Day0\]): * ≥ 30% reduction of the patient's dryness VAS * ≥ 30% reduction of the patient's fatigue VAS * ≥ 30% reduction of the patient's musculoskeletal pain VAS * ≥ 30% reduction of the physician's systemic activity VAS * ≥ 25% reduction of serum levels of any of the following B cell activation biomarkers (free light chains of immunoglobulin, beta2-microglobulin, monoclonal component, cryoglobulinemia, IgG) or ≥ 25% C4 increase
Time frame: week 28
safety and tolerability of belimumab
Evaluate the safety and tolerability of belimumab in subjects with SS
Time frame: 52 weeks
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris