Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00660881

Collaborator

(none)

210

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Biological: Epratuzumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMAB 1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.	Biological: Epratuzumab Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.

Arm

Intervention/Treatment

Experimental: EMAB

1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.

Biological: Epratuzumab

Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.

Outcome Measures

Primary Outcome Measures

Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits) [12 Week treatment cycles]

Secondary Outcome Measures

The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status [Every 4 weeks through week 48, then every 12 weeks through completion]
The combined response index including an additional criteria involving the SF-36 response [Every 12 weeks]
BILAG score assessment [Every 4 weeks through week 48, then every 12 weeks through completion]
SLEDAI scores assessment [Every 4 weeks through week 48, then every 12 weeks through completion]
Patient and physician VAS [Every 4 weeks through week 48, then every 12 weeks through completion]
Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline [Every 12 weeks]
SF-36 PCS, MCS [Every 12 weeks]
EQ-5D results [Every 12 weeks]
Proportion of patients meeting treatment failure [Every 12 weeks]
Total daily steroid dose [Every 4 weeks for the first 48 weeks and then every 12 weeks]
Time to flare for patients who entered the study without flare as defined by the BILAG [over the entire course of the trial]
SLEDAI responder [Every 4 weeks for the first 48 weeks and then every 12 weeks]
Time to sustained response for patients entering SL0008 with flare as defined by the BILAG. [over the entire course of the trial]
Immunogenicity as measured by human anti-human antibodies [at each dosing visit and 4 weeks post first dose of each treatment cycle]
Assessment of changes in baseline in levels of circulating B and T cells [The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
Patients must have maintained eligibility requirements throughout their participation in SL0007
Written informed consent signed prior to initiation of any study-specific assessments at visit 1

Exclusion Criteria:

Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine

2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day

Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Tucson	Arizona	United States
3	La Jolla	California	United States
4	Los Angeles	California	United States
5	San Leandro	California	United States
6	Denver	Colorado	United States
7	Farmington	Connecticut	United States
8	Tampa	Florida	United States
9	Chapel Hill	North Carolina	United States
10	Charlotte	North Carolina	United States
11	Durham	North Carolina	United States
12	Wilmington	North Carolina	United States
13	Oklahoma City	Oklahoma	United States
14	Arlington	Virginia	United States
15	Brussels		Belgium
16	Leuven		Belgium
17	Goiania	GO	Brazil
18	Porto Alegre		Brazil
19	Sao Paulo		Brazil
20	Shatin		Hong Kong
21	Debrecen		Hungary
22	Zalaegerszeg		Hungary
23	Madurai	Tamilnadu	India
24	Bangalore		India
25	Hyderabad		India
26	Manipal		India
27	Nagpur		India
28	Kaunas		Lithuania
29	Klaipeda		Lithuania
30	Vilnius		Lithuania
31	Elblag		Poland
32	Konskie		Poland
33	Lublin		Poland
34	Poznan		Poland
35	Torun		Poland
36	Barcelona		Spain
37	Santander		Spain
38	Donetsk		Ukraine
39	Ivano-Frankivsk		Ukraine
40	Kiev		Ukraine
41	Lviv		Ukraine
42	Birmingham		United Kingdom