Study of Epratuzumab in Systemic Lupus Erythematosus

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: Epratuzumab

• Registration Number: NCT00383513
• Lead Sponsor: UCB Pharma

Brief Summary

Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.

Detailed Description

Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-10-02
• Study First Posted: 2006-10-03
• Primary Completion: 2012-01
• Study Completion: 2012-01
• 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: 29

Inclusion Criteria

• Must have participated in SL0003 or SL0004 and benefitted from participation in those studies

Exclusion Criteria

• Development of toxicity to epratuzumab
• Significant protocol deviations during the SL0003 or SL0004 studies
• Evidence of significant infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epratuzumab	Epratuzumab	-

Primary Outcome Measures

Name	Time	Method
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)	From Entry Visit 1 through end of treatment (approximately 6 years)
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)	From Entry Visit 1 through end of treatment (approximately 6 years)

Secondary Outcome Measures

Name	Time	Method
Time to treatment failure from First Visit through end of treatment (approximately 6 years)	From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)	Treatment failure is defined as initiation of a protocol specified prohibited medication.
Epratuzumab plasma concentration levels at Week 0	Week 0
Epratuzumab plasma concentration levels at Week 48	Week 48
Epratuzumab plasma concentration levels at Week 96	Week 96
Epratuzumab plasma concentration levels at Week 144	Week 144
Epratuzumab plasma concentration levels at Week 192	Week 192
Number of subjects with anti-epratuzumab antibody in plasma at Week 48	Week 48
Number of subjects with anti-epratuzumab antibody in plasma at Week 96	Week 96
Epratuzumab plasma concentration levels at Week 240	Week 240
Subject Epratuzumab plasma concentration levels at Week 288	Week 288
Number of subjects with anti-epratuzumab antibody in plasma at Week 0	Week 0
Number of subjects with anti-epratuzumab antibody in plasma at Week 144	Week 144
Number of subjects with anti-epratuzumab antibody in plasma at Week 192	Week 192
Number of subjects with anti-epratuzumab antibody in plasma at Week 240	Week 240
Number of subjects with anti-epratuzumab antibody in plasma at Week 288	Week 288
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score	Baseline, Last Visit
Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score	Baseline, Last Visit
Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)	Baseline, Last Visit	Five point scale where 1 = very poor and 5 = very good.
Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)	Baseline, Last Visit	Five point scale where 1 = very poor and 5 = very good.