Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Monoclonal antibody, B-Cell immunotherapy
Brief summary
The primary objective of the study is to assess the dose response and the dose frequency 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 Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.
OTHERPlacebo
Phosphate-buffered Saline (PBS) infusion.
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Positive ANA result at visit 1 * Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met * Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present * If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.
Exclusion criteria
* Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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 | Description |
|---|---|---|
| Response at Week 12 according to a combined response index | Week 12 | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12 | Baseline, Week 12 | — |
| Response at Week 4 according to a combined response index | Week 4 | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status. |
| Response at Week 8 according to a combined response index | Week 8 | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status. |
| Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response | Week 4 | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response. |
| Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response | Week 8 | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response. |
| Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response | Week 12 | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response. |
| Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4 | Baseline, Week 4 | — |
| Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8 | Baseline, Week 8 | — |
| Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12 | Baseline, Week 12 | — |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2 | Baseline, Week 2 | — |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4 | Baseline, Week 4 | — |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8 | Baseline, Week 8 | — |
| Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12 | Baseline, Week 12 | — |
| Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24 | Baseline, Week 24 | — |
| Change from baseline in patient global assessment at Week 12 | Baseline, Week 12 | — |
| Short Form-36 (SF-36) response at Week 2 | Baseline, Week 2 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores. |
| Short Form-36 (SF-36) response at Week 4 | Baseline, Week 4 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores |
| Short Form-36 (SF-36) response at Week 8 | Baseline, Week 8 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores |
| Short Form-36 (SF-36) response at Week 12 | Baseline, Week 12 | SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores |
| European Quality of Life-5 Dimensions (EQ-5D) score at Week 12 | Week 12 | — |
| Time to first sustained British Isles Lupus Assessment Group (BILAG) response | From Baseline to Week 12 | — |
| Time to enhanced British Isles Lupus Assessment Group (BILAG) response | From Baseline to Week 12 | — |
| Treatment failure up to Week 12 | From Baseline to Week 12 | Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids. |
| Cumulative steroid dose at Week 12 | From Baseline to Week 12 | — |
| Human anti-human antibodies (HAHA) levels at Week 12 | Week 12 | — |
| Change from baseline in levels of circulating B cells at Week 12 | Baseline, Week 12 | — |
| Change from baseline in levels of circulating T cells at Week 12 | Baseline, Week 12 | — |
| Change from baseline in physician global assessment at Week 12 | Baseline, Week 12 | — |
Countries
Belgium, Brazil, Hong Kong, Hungary, India, Lithuania, Poland, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed