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Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

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NCT00714116

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33143 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00714116
Pfizer
Completed
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

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[email protected]

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Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
NCT00714116
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Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Systemic Lupus Erythematosus
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).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lupus Erythematosus, Systemic
Drug: SBI-087
Single IV or SC dose of SBI-087
Experimental: SBI-087
Intervention: Drug: SBI-087
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.
 
Completed
30
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT00714116
3227K2-1002
B2261004
No
Not Provided
Not Provided
Pfizer
Pfizer
Emergent Product Development Seattle LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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