Trials / Completed
CompletedNCT00624351
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 227 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Epratuzumab | Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure. |
| OTHER | Placebo | Phosphate-buffered Saline (PBS) infusion. |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2009-08-01
- Completion
- 2009-08-01
- First posted
- 2008-02-27
- Last updated
- 2011-09-12
Locations
53 sites across 11 countries: United States, Belgium, Brazil, Hong Kong, Hungary, India, Lithuania, Poland, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00624351. Inclusion in this directory is not an endorsement.