Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
NCT ID: NCT00714116
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-03-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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SBI-087
SBI-087
Single IV or SC dose of SBI-087
Interventions
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SBI-087
Single IV or SC dose of SBI-087
Eligibility Criteria
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Inclusion Criteria
* History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Emergent Product Development Seattle LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Arthritis & Rheumatology Care Center
South Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
MRA Clinical Research
South Miami, Florida, United States
Duke University Medical Center
Durham, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Countries
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References
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Cohen S, Clowse M, Pardo P, Bhattacharya I, Menon S, Gourley I, Diehl A. Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase 1 Dose Escalating Studies in Patients With Either Mild Rheumatoid Arthritis or Systemic Lupus. Clin Ther. 2016 Jun;38(6):1417-1434.e2. doi: 10.1016/j.clinthera.2016.03.028. Epub 2016 Apr 21.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2261004
Identifier Type: OTHER
Identifier Source: secondary_id
3227K2-1002
Identifier Type: -
Identifier Source: org_study_id
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