Systemic Lupus Erythematosus
Conditions
Brief summary
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
Interventions
Intravenous injection
Sponsors
Baxalta now part of Shire
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
* Signed and dated written informed consent obtained from the subject * Males and females of age 18 years and older at the time of screening * Established diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria * Documented renal biopsy evidence of proliferative glomerulonephritis prior to screening * Urine protein-to-creatinine ratio \> 0.5 (mg/mg)
Exclusion criteria
* Any significant health problem other than lupus or lupus nephritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality | Week 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma pharmacokinetic parameters | Week 21 | Maximum concentration (Cmax), minimum concentration (Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL) , mean residence time (MRT), volume of distribution at steady state (Vdss) |
Countries
Australia, Canada, Mexico, New Zealand, United States
Outcome results
None listed