A Phase 2, proof of concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with primary Sjögren?s Syndrome. - ND

• Conditions: Subjects with have a diagnosis of primary SS according to the updated American European Consensus Group Criteria (8). In addition, patients must be always positive for anti-SSA or anti-SSB antibodies (of note, the quasi totality of patients positive for anti-SSB are also positive for anti-SSA); MedDRA version: 9.1Level: SOCClassification code 10021428

• Registration Number: EUCTR2008-008045-38-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. MARIA DELLA MISERICORDIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Are at least 18 years of age - Have a diagnosis of primary SS. In addition, patients must be always positive for anti-SSA or anti-SSB antibodies. Have the presence, at screening, of a)Systemic involvement or persistent (= 2 months) parotid, submandibular or lacrymal gland swelling of more than 2 cm OR b) 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 (>15g/L) - 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

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Have received treatment with any BLyS-targeted - Have received any of the following within 364 days of Day 0: B-cell targeted therapy Abatacept A biologic investigational agent other than B cell targeted therapy - Have required 3 or more courses of systemic corticosteroids for concomitant conditions within 364 days of Day 0. Have received intravenous (IV) or oral cyclophosphamide within 180 days of Day 0 - Have received any of the following within 90 days of Day 0: Anti-TNF therapy, Anakira, Intravenous immunoglobulin (IVIG), prednisone > 100 mg/day, Plasmapheresis. Have received any sperimental new drug. Have received any of the following within 30 days of Day 0: A change in dose of a corticosteroid, other immunosuppressive/immunomodulatory agent, anti-malarial, NSAID) Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. 10. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SS. Have a 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. 13. Have required management of acute or chronic infections Hospitalization for treatment of infection within 60 days of Day 0. Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0. Positive Pregnancy Test Not informed consens

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified