Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Sponsor

UCB Pharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00113971

Collaborator

(none)

Enrollment

Locations

Duration (Months)

6.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic	Drug: epratuzumab	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia Presbyterian Medical Center	New York	New York	United States	10032
2	Lupus Center of Excellence	Pittsburgh	Pennsylvania	United States	15261
3	Rheumatology Associates	Charleston	South Carolina	United States	29407