This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
Response as measured by American College of Rheumatology criteria (ACR 20 response)
Time frame: 16 weeks
ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response
Time frame: up to 24 weeks
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200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Pfizer Investigational Site
Paradise Valley, Arizona, United States
Pfizer Investigational Site
Palm Desert, California, United States
Pfizer Investigational Site
Santa Monica, California, United States
Pfizer Investigational Site
Westlake Village, California, United States
Pfizer Investigational Site
Newark, Delaware, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Palm Harbor, Florida, United States
Pfizer Investigational Site
Springfield, Illinois, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Grand Rapids, Michigan, United States
...and 45 more locations