Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus|
- Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
- Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.
|Study Start Date:||April 2005|
|Study Completion Date:||June 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|Lupus Center of Excellence|
|Pittsburgh, Pennsylvania, United States, 15261|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29407|
|Study Director:||Anna Barry||UCB, Inc.|