Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
NCT00714116
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus | |||
Official Title ICMJE | An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus. | |||
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). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Lupus Erythematosus, Systemic | |||
Intervention ICMJE | Drug: SBI-087
Single IV or SC dose of SBI-087 | |||
Study Arms ICMJE | Experimental: SBI-087
Intervention: Drug: SBI-087 | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 30 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Actual Study Completion Date ICMJE | September 2012 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | Canada | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00714116 | |||
Other Study ID Numbers ICMJE | 3227K2-1002 B2261004 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Emergent Product Development Seattle LLC | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |