Status:
COMPLETED
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Emergent Product Development Seattle LLC
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
Eligibility Criteria
Inclusion
- Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
- Rheumatoid arthritis disease onset at \>16 years of age and duration of disease at least 6 months.
- Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.
Exclusion
- Any significant health problems other than rheumatoid arthritis.
- Treatment of greater than 10 mg of prednisone per day.
- Therapy with immunosuppressants within 6 months before study day 1
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00815906
Start Date
December 1 2008
End Date
May 1 2012
Last Update
August 14 2024
Active Locations (7)
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1
Pfizer Investigational Site
Ehime, Japan
2
Pfizer Investigational Site
Fukui, Japan
3
Pfizer Investigational Site
Kanagawa, Japan
4
Pfizer Investigational Site
Miyagi, Japan