Study of Epratuzumab in Systemic Lupus Erythematosus

Sponsor

UCB Pharma (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00382837

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

Study Start Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE. []

Secondary Outcome Measures

To continue to assess the efficacy and tolerability of epratuzumab; []
To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; []
To continue to assess epratuzumab on Health-related quality of life in lupus patients; []
To continue to assess disease status as reported by the patient and physician. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria:

Development of toxicity to Epratuzumab
Significant protocol deviations from SL0003 Study.

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	Farmington	Connecticut	United States
6	Washington	District of Columbia	United States
7	Aventura	Florida	United States
8	Chicago	Illinois	United States
9	Baltimore	Maryland	United States
10	Bronx	New York	United States
11	New York	New York	United States
12	Syracuse	New York	United States
13	Durham	North Carolina	United States
14	Winston-Salem	North Carolina	United States
15	Gallipolis	Ohio	United States
16	Tulsa	Oklahoma	United States
17	Charleston	South Carolina	United States
18	Dallas	Texas	United States
19	Arlington	Virginia	United States
20	Edmonds	Washington	United States
21	Brussels		Belgium
22	Liege		Belgium
23	Rio De Janeiro	RJ	Brazil
24	Goiania		Brazil
25	Rio De Janeiro		Brazil
26	Sao Paulo		Brazil
27	Winnipeg	Manitoba	Canada
28	Hradec Kralove		Czech Republic
29	Olomouc		Czech Republic
30	Praha 2		Czech Republic
31	Paris		France
32	Toulouse Cedex 9		France
33	Erlangen		Germany
34	Heidelberg		Germany
35	Mannheim		Germany
36	München		Germany
37	Debrecen		Hungary
38	Pecs		Hungary
39	Ancona		Italy
40	Brescia		Italy
41	Amsterdam		Netherlands
42	Groningen		Netherlands
43	Leiden		Netherlands
44	Piestany		Slovakia
45	Barcelona		Spain
46	Madrid		Spain
47	Santander		Spain
48	Sevilla		Spain
49	Leeds	West Yorkshire	United Kingdom
50	Birmingham		United Kingdom
51	London		United Kingdom
52	Manchester		United Kingdom
53	Newcastle Upon Tyne		United Kingdom
54	Sheffield		United Kingdom