NCT00689728

A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy

A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFα Inhibitor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	LY2127399	LY2127399 will be administered as a single IV infusion over 30 minutes.
DRUG	Placebo	Placebo will be administered as a single IV infusion over 30 minutes.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-02-01
• Completion: 2010-05-01
• First posted: 2008-06-04
• Last updated: 2018-12-06
• Results posted: 2018-12-06

Locations

45 sites across 10 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Germany, Mexico, Poland, Puerto Rico