The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Valerious Medical Group Research Center
Long Beach, California, United States
Tampa Medical Group, PA
Tampa, Florida, United States
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.
SEE ALSO ADVERSE EVENTS RESULTS SECTION
Time frame: Up to 24 weeks
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24
Time frame: Baseline, 24 weeks
Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.
Time frame: Baseline, 24 Weeks
Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24
Time frame: Baseline, 24 weeks
Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24
Time frame: Baseline, 24 weeks
Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time frame: Baseline, 24 Weeks
Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.
Time frame: Baseline, 24 weeks
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Fiechtner Research, Inc.
Lansing, Michigan, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
Lake Success, New York, United States
Rheumatology Associates
Smithtown, New York, United States
STAT Research, Inc.
Dayton, Ohio, United States
Oklahoma Center for Arthritis Therapy & Research
Tulsa, Oklahoma, United States
Houston Institute for Clinical Research
Houston, Texas, United States
...and 1 more locations
Absolute Change From Baseline in IgA at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in IgA at Week 24
Time frame: Baseline, 24 weeks
Absolute Change From Baseline in IgG at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in IgG at Week 24
Time frame: Baseline, 24 Weeks
Absolute Change From Baseline in IgM at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in IgM at Week 24
Time frame: Baseline, 24 weeks
Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Time frame: Baseline, 24 Weeks
Mean Percent Change From Baseline in PGA Score at Week 24.
The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Time frame: Baseline, 24 weeks
Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.
Time frame: Baseline, 24 Weeks
Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24
Time frame: Baseline, 24 weeks
Absolute Change From Baseline in Complement C3 at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in Compliment C3 at Week 24
Time frame: Baseline, 24 Weeks
Absolute Change From Baseline in Complement C4 at Week 24
Time frame: Baseline, 24 weeks
Median Percent Change From Baseline in Complement C4 at Week 24
Time frame: Baseline, 24 Weeks
Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in Anti-dsDNA at Week 24
Time frame: Baseline, 24 weeks
Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in HDL at Week 24
Time frame: Baseline, 24 week
Absolute Change From Baseline in Total Cholesterol at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in Total Cholesterol at Week 24
Time frame: Baseline, 24 Weeks
Median Percent Change From Baseline in Triglycerides at Week 24
Time frame: Baseline, 24 weeks
Absolute Change From Baseline in Triglycerides at Week 24
Time frame: Baseline, 24 Weeks