A Study in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399; Placebo Q4W; Placebo Q2W
Intervention description: Administered Subcutaneously (SC); Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 456.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The primary purpose of this study is to help answer if LY2127399 is safe and effective in the
      treatment of rheumatoid arthritis in participants with an inadequate response to one or more
      tumor necrosis factor-alpha (TNF-α) inhibitors.

      This study is comprised of 2 periods:

      Period 1: 24-week blinded treatment

      Period 2: 48-week post-treatment follow-up
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of 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 1 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 anti-inflammatory drugs (NSAIDS) in the past 6
             weeks

          -  Steroid injection or intravenous (IV) infusion in the last 6 weeks

          -  Use of more than 10 milligrams/day (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 (for example, 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