Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis
NCT00641225
ABOUT THIS STUDY
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- Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
- Must meet criteria for rheumatoid arthritis with functional class I to III.
- Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age
- Any significant health problems other than rheumatoid arthritis.
- Treatment of greater than 10 mg of prednisone per day.
- Treatment with cyclophosphamide.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis | |||
Official Title ICMJE | An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis | |||
Brief Summary | The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Rheumatoid Arthritis | |||
Intervention ICMJE | Drug: SBI-087
Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg. | |||
Study Arms ICMJE | Experimental: 1
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 | 62 | |||
Original Estimated Enrollment ICMJE | 46 | |||
Actual Study Completion Date ICMJE | March 2011 | |||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00641225 | |||
Other Study ID Numbers ICMJE | 3227K1-1000 B2261001 | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |