Efficacy and Safety of Belimumab in Primary Sjögren's Syndrome
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ClinicalTrials.gov Identifier: NCT01008982 |
Recruitment Status :
Completed
First Posted : November 6, 2009
Last Update Posted : September 5, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sjögren's Syndrome | Drug: LimphoStat-B | Phase 2 |
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 Sjögren's Syndrome (pSS)
Clinical Development Phase: 2
A total of 15 patients will be recruited
Objectives
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
This is a Phase 2, proof of concept, 52-week open study to evaluate the efficacy and safety of belimumab in subjects with active SS. In addition to receiving standard stable therapy, subjects will receive 10 mg/kg belimumab. At week 28, if worsening any patient will exit the study band considered as a treatment failure.
If the disease is stable at week 28, and if both the referent clinician and the patient agree in continuing the study, the study will continue up to week 52 in that patient, since a delayed response may occur (as shown in systemic lupus erythematosus patients treated with belimumab: Chathman et al. Arthritis Rheumatism 2008 ).
Inclusion criteria
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
c) SS of more recent onset, i.e., less than 5 years of duration of symptoms, associated with: i) oral or ocular dryness and ii) fatigue and iii) 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: single arm |
Drug: LimphoStat-B
subjects will receive 10 mg/kg belimumab, in solution for infusion, monthly
Other Name: Belimumab |
- 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 [ Time Frame: week 28 and week 52 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Are at least 18 years of age.
- Have a diagnosis of primary SS according to the updated American European Consensus Group Criteria -
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008982
Italy | |
Salvatore De Vita | |
Udine, Italy, 33100 |
Principal Investigator: | Salvatore De Vita, MD | Rheumatology Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Salvatore De Vita, prof, MD, University of Udine |
ClinicalTrials.gov Identifier: | NCT01008982 History of Changes |
Other Study ID Numbers: |
SS-BEL-01-1.0 |
First Posted: | November 6, 2009 Key Record Dates |
Last Update Posted: | September 5, 2012 |
Last Verified: | September 2012 |
Belimumab,Sjögren's Syndrome. Have a diagnosis of primary SS according to the updated American European Consensus Group Criteria |
Sjogren's Syndrome Syndrome Disease Pathologic Processes 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 Autoimmune Diseases Immune System Diseases Belimumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |