Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis
2 other identifiers
interventional
60
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Mar 2008
Longer than P75 for phase_1 rheumatoid-arthritis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedStudy Start
First participant enrolled
March 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2011
CompletedSeptember 13, 2023
September 1, 2023
3 years
March 18, 2008
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.
12 months
Secondary Outcomes (1)
To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis.
12 months
Study Arms (1)
1
EXPERIMENTALSBI-087
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any significant health problems other than rheumatoid arthritis.
- Treatment of greater than 10 mg of prednisone per day.
- Treatment with cyclophosphamide.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Emergent Product Development Seattle LLCcollaborator
Study Sites (6)
Pfizer Investigational Site
Miami, Florida, 33143, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Dallas, Texas, 75231, United States
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7, Canada
Pfizer Investigational Site
Toronto, Ontario, M9L 3A2, Canada
Pfizer Investigational Site
Montreal, Quebec, H3P 3P1, Canada
Related Publications (1)
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.
PMID: 27112532DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
March 31, 2008
Primary Completion
March 31, 2011
Study Completion
March 31, 2011
Last Updated
September 13, 2023
Record last verified: 2023-09