Trials / Completed
CompletedNCT01632241
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 503 (actual)
- Sponsor
- Human Genome Sciences Inc., a GSK Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).
Detailed description
Study participants receive stable standard therapy for lupus in addition to receiving either placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks. The random assignment in this study is "2 to 1" which means that for every 3 participants, 2 will receive belimumab and 1 will receive placebo. Participants who successfully complete the 52-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab plus standard therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo plus standard therapy | Placebo plus standard therapy |
| BIOLOGICAL | Belimumab 10 mg/kg plus standard therapy | Belimumab 10mg/kg plus standard therapy |
| DRUG | Standard therapy | Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted. |
Timeline
- Start date
- 2013-02-19
- Primary completion
- 2018-06-18
- Completion
- 2019-01-28
- First posted
- 2012-07-02
- Last updated
- 2021-09-08
- Results posted
- 2019-07-05
Locations
96 sites across 6 countries: United States, Brazil, Colombia, France, South Africa, United Kingdom
Source: ClinicalTrials.gov record NCT01632241. Inclusion in this directory is not an endorsement.