drugset / Trial / NCT00724867
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.
Timeline
- Start
- 2008-08
- Primary completion
- 2015-03
- Completion
- 2015-03
Publications
- Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment. Arthritis Care Res (Hoboken). 2019 Jun;71(6):829-838. doi: 10.1002/acr.23788. Epub 2019 Apr 29.
- Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Belimumab | Monoclonal antibody | 10 mg/kg | Intravenous |