Arthritis, Rheumatoid
Conditions
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.
Interventions
DRUGSBI-087
IV, Single dose
Sponsors
Emergent Product Development Seattle LLC
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as determined by the number and severity of adverse events at the different dose levels | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed