A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399; Placebo Q2W; Placebo Q4W; Methotrexate
Intervention description: Administered Subcutaneously (SC); Administered SC; Administered SC; Methotrexate is a background therapy.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1041.0
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 while on a background treatment of methotrexate.

      This study is comprised of 3 periods:

      Period 1: 52-week blinded treatment

      Period 2: additional 48-week unblinded treatment

      Period 3: 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

          -  Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable
             during the past 8 weeks

          -  At least 8 tender and swollen joints

          -  At least one erosion of a hand or foot joint observed on an X-ray

          -  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

          -  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 an inadequate response to a biologic disease-modifying anti-rheumatic drug
             (DMARD)

          -  History of a serious reaction to other biological DMARDs

          -  History of the use of rituximab or other B cell therapy

          -  Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8
             weeks

          -  Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed
             up the elimination of leflunomide)

          -  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

          -  History of the use of rituximab, any other B cell targeted biotherapy, or denosumab