Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Monoclonal antibody, B-Cell immunotherapy
Brief summary
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
Interventions
BIOLOGICALEpratuzumab
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.
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Proportion of patients meeting treatment failure | Every 12 weeks |
Countries
Belgium, Brazil, Hong Kong, Hungary, India, Lithuania, Poland, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed