Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
- Registration Number
- NCT00815906
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SBI-087 0.5 mg IV SBI-087 - SBI-087 100 mg SC SBI-087 - SBI-087 0.15 mg IV SBI-087 - SBI-087 200 mg SC SBI-087 -
- Primary Outcome Measures
Name Time Method Safety and tolerability as determined by the number and severity of adverse events at the different dose levels 12 months
- Secondary Outcome Measures
Name Time Method To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087 12 month To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA 12 months To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087 12 month
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Tokyo, Japan