Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis
Phase 1
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: SBI-087
- Registration Number
- NCT00641225
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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
Read More
Exclusion Criteria
- Any significant health problems other than rheumatoid arthritis.
- Treatment of greater than 10 mg of prednisone per day.
- Treatment with cyclophosphamide.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 SBI-087 SBI-087
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis. 12 months
- Secondary Outcome Measures
Name Time Method To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis. 12 months
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇦Montreal, Quebec, Canada