A Rheumatoid Arthritis Study in Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1004.0
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 with or without background disease-modifying anti-rheumatic
      drug (DMARD) therapy.

      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 Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years

          -  Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal
             to 20/100 millimeters (mm)

          -  If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at
             randomization, must have been on a stable dose for at least 8 weeks prior to study
             start.

          -  Women 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 milligrams per day (mg/day) of oral steroids in the last 6 weeks

          -  Use of biologic DMARD concurrently or recently

          -  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 prior to study start, 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 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