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: 9.1 Level: SOC Classification code 10021428
Conditions
Interventions
Product Name: LYMPHOSTAT-B
Product Code: HGS1006
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Lymphostat-B - Belimumab
Concentration unit: mg/kg milligram(s)/
Sponsors
AZIENDA OSPEDALIERA S. MARIA DELLA MISERICORDIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the proof of concept of efficacy of belimumab in subjects with SS To evaluate the safety and tolerability of belimumab in subjects with SS;Secondary Objective: 1. = 30% reduction of patient’s dryness VAS 2. = 30% reduction of patient’s fatigue VAS 3. = 30% reduction of patient’s musculoskeletal pain VAS 4. = 30% reduction of physician’s systemic activity VAS 5. = 25% reduction of serum levels of any of the following B cell activation biomarkers (IgG, free light chain of immunogobulins, beta2-microglobulin, monoclonal component, cryoglobulinemia) or = 25% C4 increase 6. = 30% reduction of Physician’s Global Assessment (PGA) ;Primary end point(s): • A response is defined as: • Fulfillment of any 2 of the 5 following response criteria: o = 30% reduction of patient’s dryness VAS o = 30% reduction of patient’s fatigue VAS o = 30% reduction of patient’s musculoskeletal pain VAS o = 30% reduction of physician’s systemic activity VAS o = 25% reduction of serum levels of any of the following B cell activation biomarkers (free light chains of immunogobulins, beta2-microglobulin, monoclonal component, cryoglobulinemia, IgG) or = 25% C4 increase The choice of improvement of 2 of the 5 criteria is justified by the fact that some patients could be improved only on systemic signs, and thus could be improved on the 2 last items (physician VAS and B-cell biomarkers). Conversely, a patient with no systemic sign could be included in case of increase of B-cell biomarkers. If his B-cell markers do not change, he could benefit from the drug if 2 out of his 3 VAS (dryness, fatigue, pain) improve. | — |
Countries
Italy
Outcome results
None listed