Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Phase 2

Terminated

• Conditions: Lupus Erythematosus, Systemic

• Registration Number: NCT00113971
• Lead Sponsor: UCB Pharma

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 Description

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-06-10
• Study First Submitted QC: 2005-06-10
• Study First Posted: 2005-06-13
• Primary Completion: 2007-03
• Study Completion: 2007-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
• Has had SLE for at least 6 months prior to study entry
• Has at least one elevated autoantibody level at study entry
• Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)

Exclusion criteria:

• Active Severe Lupus as defined by BILAG Index Level A in any body system or organ
• Allergy to human antibodies or Murine
• Prior therapy with other anti-B cell antibodies

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.

Secondary Outcome Measures

Name	Time	Method
Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.

Trial Locations

Locations (3)

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States

Lupus Center of Excellence; 🇺🇸 Pittsburgh, Pennsylvania, United States

Rheumatology Associates; 🇺🇸 Charleston, South Carolina, United States