Lupus Erythematosus, Systemic
Conditions
Keywords
study of epratuzumab in systemic lupus erythematosus, systemic lupus erythematosus, SLE
Brief summary
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.
Detailed description
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.
Interventions
DRUGepratuzumab
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has SLE by American College of Rheumatology revised criteria (meets \>/= 4 criteria) * Has had SLE for at least 6 months prior to study entry * Has at least one elevated autoantibody level at study entry * Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)
Exclusion criteria
* Active Severe Lupus as defined by BILAG Index Level A in any body system or organ * Allergy to human antibodies or Murine * Prior therapy with other anti-B cell antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability. | — |
Countries
United States
Outcome results
None listed