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

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).

Inclusion Criteria:

• Have given written informed consent approval
• Women must not be at risk to become pregnant during study participation
• Diagnosis of Rheumatoid Arthritis
• Active Rheumatoid Arthritis
• Current, regular use of Methotrexate, at a stable dose
• Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
• Other criteria to be reviewed by study doctor

Exclusion Criteria:

• Use of excluded medications (reviewed by study doctor)
• Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
• Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
• Evidence of tuberculosis
• Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
• Other criteria to be reviewed by study doctor