A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)

Inclusion Criteria:

- Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years

- At least 8 tender and swollen joints

- An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate
(ESR)

- Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP)
antibody

- Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab,
golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy
or intolerance

- Regular use of at least one conventional disease-modifying anti-rheumatic drug
(DMARD), with a stable dose for at least 8 weeks prior to study start

- Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

- Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6
weeks

- Steroid injection or intravenous (IV) infusion in the last 6 weeks

- Use of more than 10 mg/day of oral steroids in the last 6 weeks

- History of a serious reaction to other biological DMARDs

- Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8
weeks

- Surgery on a joint or other major surgery less than 2 months ago, or plans to have
joint surgery or major surgery during the study

- Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's
disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory
condition except RA

- Cervical cancer or squamous skin cancer within the past 3 years, or other cancer
within the past 5 years

- Received a live vaccine received within the past 12 weeks (for example, vaccines for
measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)

- Hepatitis or human immunodeficiency virus (HIV)

- A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months
or a serious bone or joint infection within 6 months

- Symptoms of herpes zoster or herpes simplex within the last month

- Active or latent tuberculosis (TB)

- Current symptoms of a serious disorder or illness

- Use of an investigational drug within the last month