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

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00660881
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Study Start: 2008-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-07
• Disposition First Submitted: 2012-07-03
• Disposition First Submitted QC: 2012-07-03
• Last Update Submitted: 2012-07-03
• Disposition First Posted: 2012-07-12
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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