Status:
COMPLETED
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Emergent Product Development Seattle LLC
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
Eligibility Criteria
Inclusion
- Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology \[ACR\] Revised Criteria) greater than 6 months before study day 1.
- History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.
Exclusion
- Treatment with more than 20 mg of prednisone per day.
- Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE.
- History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00714116
Start Date
March 1 2009
End Date
September 1 2012
Last Update
December 7 2018
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Arthritis & Rheumatology Care Center
South Miami, Florida, United States, 33143
2
Miami Research Associates
South Miami, Florida, United States, 33143
3
MRA Clinical Research
South Miami, Florida, United States, 33143
4
Duke University Medical Center
Durham, North Carolina, United States, 27710