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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antibodies, Monoclonal; Methotrexate

Criteria

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