Status:
COMPLETED
Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Human Genome Sciences Inc.
Conditions:
Sjögren's Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- Have a diagnosis of primary SS according to the updated American European Consensus Group Criteria. In addition, patients must be always positive for anti-SSA or anti-SSB antibodies
- Have the presence, at screening, of Systemic involvement (polysynovitis, skin, renal, lung, CNS involvement, peripheral neuropathy, vasculitis, autoimmune cytopenia, defined in Annex 1) or persistent (up to 2 months) parotid, submandibular or lachrymal gland swelling of more than 2 cm OR
- 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:
- oral or ocular dryness
- fatigue
- musculoskeletal pain (i.e, 3 criteria for response as reported at page (ix-x), characterized by VAS score more than 50/100 in all the 3 fields.
Exclusion
- 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:
- B-cell targeted therapy (eg, rituximab, other anti-CD20 agents, anti-CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\]
- A biologic investigational agent other than B cell targeted therapy (eg, abetimus sodium, anti CD40L antibody \[BG9588/ IDEC 131\]).
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01160666
Start Date
March 1 2010
End Date
June 1 2012
Last Update
July 3 2012
Active Locations (1)
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1
Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
Le Kremlin-Bicêtre, France, 94275