Efficacy and Safety of Belimumab in Primary Sjögren's Syndrome

NCT01008982 | Completed Phase 2 DMC

• 1 other identifier: SS-BEL-01-1.0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Background and rationale Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by chronic inflammation of salivary and lachrymal glands, frequently accompanied by systemic symptoms. The presence of various autoantibodies such as rheumatoid factor (RF) and anti-SSA/SSB antibodies, as well as hypergammaglobulinemia, reflect B cell hyperactivity. About five percent of patients with SS develop malignant B cell lymphoma, usually of the mucosa-associated lymphoid tissue (MALT) type and most frequently located in the major salivary glands. Currently, there is a lack of evidence-based intervention therapy which may influence SS-related chronic inflammation and lymphoproliferation. B cells are involved in the pathogenesis of SS, and B cell downregulation may lead to a decrease of disease activity. Patients with more residual exocrine gland function, e.g., those with SS of shorter duration, might better benefit from systemic therapy, as reported in a preliminary study on the efficacy of B-cell depletion in SS.This study will examine the effect of the drug Belimumab in patients with SS. Patients aged more than 18 years with SS may be eligible for this study. Candidates will be screened with complete history and physical examination, chest x-rays, and oral and eye examinations.

Conditions

Sjögren's Syndrome

Keywords

Belimumab,Sjögren's Syndrome.; Have a diagnosis of primary SS according to the updated American European Consensus Group Criteria

Outcome Measures

Primary Outcomes (1)

• 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

  week 28 and week 52

Study Arms (1)

single arm

EXPERIMENTAL

Drug: LimphoStat-B

Interventions

LimphoStat-B DRUG

subjects will receive 10 mg/kg belimumab, in solution for infusion, monthly

Also known as: Belimumab

single arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years of age.
• Have a diagnosis of primary SS according to the updated American European Consensus Group Criteria -

You may not qualify if:

• Have received treatment with any BLyS-targeted (BLyS-receptor fusion protein \[BR3\], TACI Fc, or belimumab) at any time.
• Have a 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).
• Stable Grade 3 neutropenia or stable Grade 3 white blood cell count

Sponsors & Collaborators

• University of Udine: lead
• Azienda Ospedaliera S. Maria della Misericordia: collaborator

Study Sites (1)

Salvatore De Vita

Udine, Italy, 33100, Italy

Location

Related Publications (1)

• Pontarini E, Fabris M, Quartuccio L, Cappeletti M, Calcaterra F, Roberto A, Curcio F, Mavilio D, Della Bella S, De Vita S. Treatment with belimumab restores B cell subsets and their expression of B cell activating factor receptor in patients with primary Sjogren's syndrome. Rheumatology (Oxford). 2015 Aug;54(8):1429-34. doi: 10.1093/rheumatology/kev005. Epub 2015 Mar 3.

  PMID: 25740829 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

belimumab

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Salvatore De Vita, MD

  Rheumatology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof, MD

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

IT (1)