NCT01008852

Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Active Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SBI-087	200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
DRUG	SBI-087	200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
DRUG	SBI-087	200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
DRUG	SBI-087	200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
DRUG	Placebo	Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2013-07-01
• First posted: 2009-11-06
• Last updated: 2013-12-03

Locations

55 sites across 10 countries: United States, Argentina, Canada, Chile, Hungary, Japan, Mexico, Poland, Serbia, Spain