Study of Epratuzumab in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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
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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).

Official Title
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An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Biological: Epratuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epratuzumab<br> | Biological: Epratuzumab<br>* 360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure from First Visit through end of treatment (approximately 6 years) | Treatment failure is defined as initiation of a protocol specified prohibited medication. | From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years) | 
| 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 | 
| 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 48 |  | Week 48 | 
| Number of subjects with anti-epratuzumab antibody in plasma at Week 96 |  | Week 96 | 
| 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) | Five point scale where 1 = very poor and 5 = very good. | Baseline, Last Visit | 
| Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA) | Five point scale where 1 = very poor and 5 = very good. | Baseline, Last Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, Antibody, B-Cell Immunotherapy