Clinical Trial: Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: UCB Pharma

Current Primary Outcome: Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.

Original Primary Outcome:

Current Secondary Outcome: Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.

Original Secondary Outcome:

Information By: UCB Pharma

Dates:
Date Received: June 10, 2005
Date Started: April 2005
Date Completion:
Last Updated: March 30, 2012
Last Verified: March 2012