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

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

Official Title
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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

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: 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.

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: EMAB<br>1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles. | Biological: Epratuzumab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-Cell immunotherapy, Lupus, Monoclonal antibody