CLINICAL TRIALS PROFILE FOR BENLYSTA
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All Clinical Trials for BENLYSTA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01160666 ↗ | Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome | Completed | Human Genome Sciences Inc. | Phase 2 | 2010-03-01 | 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. |
| NCT01160666 ↗ | Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome | Completed | Assistance Publique - Hôpitaux de Paris | Phase 2 | 2010-03-01 | 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. |
| NCT01532310 ↗ | Belimumab (BENLYSTA®) Pregnancy Registry | Recruiting | PPD | 2012-07-16 | This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization. | |
| NCT01532310 ↗ | Belimumab (BENLYSTA®) Pregnancy Registry | Recruiting | GlaxoSmithKline | 2012-07-16 | This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization. | |
| NCT01670565 ↗ | Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis | Completed | Human Genome Sciences Inc. | Phase 2 | 2012-08-01 | This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity measured by an improvement in skin thickening and stability of pulmonary function test measurements when compared to patients treated with placebo/MMF. |
| NCT01670565 ↗ | Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis | Completed | Hospital for Special Surgery, New York | Phase 2 | 2012-08-01 | This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity measured by an improvement in skin thickening and stability of pulmonary function test measurements when compared to patients treated with placebo/MMF. |
| NCT02260934 ↗ | Rituximab and Belimumab for Lupus Nephritis | Completed | Immune Tolerance Network (ITN) | Phase 2 | 2015-07-09 | In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks. |
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