drugset / Trial / NCT01160666
Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome
Phase 2
Completed
20 enrolled
Assistance Publique - Hôpitaux de Paris
Human Genome Sciences Inc. · collab
NaSingle-groupOpen-labelTreatment
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 systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-12
- Completion
- 2012-06
Publications
- Bowman SJ, Fisher BA. Stratifying primary Sjogren's syndrome: killers in the balance? Arthritis Res Ther. 2015 Dec 7;17:351. doi: 10.1186/s13075-015-0878-9.
- Seror R, Nocturne G, Lazure T, Hendel-Chavez H, Desmoulins F, Belkhir R, Ravaud P, Benbijja M, Poirier-Colame V, Taoufik Y, Mariette X. Low numbers of blood and salivary natural killer cells are associated with a better response to belimumab in primary Sjogren's syndrome: results of the BELISS study. Arthritis Res Ther. 2015 Sep 4;17(1):241. doi: 10.1186/s13075-015-0750-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belimumab | Monoclonal antibody | 10 mg/kg | — |