Study of Epratuzumab in Systemic Lupus Erythematosus

Sponsor

UCB Pharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00111306

Collaborator

(none)

510

Enrollment

Locations

Duration (Months)

28.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: epratuzumab	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks. []

Secondary Outcome Measures

Proportion of patients with complete response or partial response; []
Individual BILAG assessments; []
Physician and patient assessment scores; []
Time-to treatment failure; []
Successful steroid reduction by weeks 20 and 24; []
Maintenance of steroid reduction at 24 and 48 weeks; []
Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; []
Assess epratuzumab on Health-related quality of life. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has SLE by ACR revised criteria (meets <4 criteria);
Has SLE with at least one elevated lupus antibody;
Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic

Exclusion Criteria:

Active severe CNS or Renal disease defined by BILAG as Level A
Allergy to murine or human antibodies
Antiphospholid antibodies AND a history of thrombocytopenic events

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Tucson	Arizona	United States
3	Los Angeles	California	United States
4	Upland	California	United States
5	Denver	Colorado	United States
6	Washington	District of Columbia	United States
7	Baltimore	Maryland	United States
8	Bronx	New York	United States
9	New York	New York	United States
10	Durham	North Carolina	United States
11	Winston-Salem	North Carolina	United States
12	Tulsa	Oklahoma	United States
13	Charleston	South Carolina	United States
14	Brussels		Belgium
15	Debrecen		Hungary
16	Amsterdam		Netherlands
17	Santander		Spain
18	Birmingham		United Kingdom