Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Antibody, B-cell immunotherapy
Brief summary
The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE.
Interventions
DRUGepratuzumab
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has SLE by ACR revised criteria (meets \<4 criteria); * Has SLE with at least one elevated lupus antibody; * Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic
Exclusion criteria
* Active severe CNS or Renal disease defined by BILAG as Level A * Allergy to murine or human antibodies * Antiphospholid antibodies AND a history of thrombocytopenic events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual BILAG assessments; | — |
| Physician and patient assessment scores; | — |
| Time-to treatment failure; | — |
| Proportion of patients with complete response or partial response; | — |
| Maintenance of steroid reduction at 24 and 48 weeks; | — |
| Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; | — |
| Assess epratuzumab on Health-related quality of life. | — |
| Successful steroid reduction by weeks 20 and 24; | — |
Countries
Belgium, Hungary, Netherlands, Spain, United Kingdom, United States
Outcome results
None listed