A Study in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2439821; Placebo
Intervention description: Subcutaneous; Subcutaneous
Intervention MeSH terms: Ixekizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 448.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis; RA

Summary:

      The primary purpose of the study is to help answer the following research questions, and not
      to provide treatment for Rheumatoid Arthritis (RA):

        -  The safety of LY2439821 and any side effects that might be associated with it.

        -  Whether LY2439821 can help participants with active RA.

        -  How much LY2439821 should be given to participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You must be between the ages of 18 and 75

          -  You must have active RA

        Qualifications Specific to the bDMARD-naive Population:

        You must be regularly using methotrexate (MTX) for at least 12 weeks before your
        participation in this study

        Qualifications Specific to the TNFα-IR Population:

          -  You must have been treated with at least 1 biologic TNFα inhibitor therapy and either
             had an insufficient response to at least 3 months of treatment OR have been intolerant
             of such treatment

          -  You must be regularly using at least 1 conventional DMARD in a stable treatment
             regimen

        Exclusion Criteria:

          -  You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you
             are on a stable dose within the last 2 weeks

          -  You are a woman who is lactating or breast feeding

          -  You have donated more than 300 milliliters (mL) of blood within the last month

          -  You have received glucocorticoid administered by intra-articular, intramuscular, or
             intravenous injection or oral corticosteroids at an average daily dose of greater than
             10 mg per day of prednisone or its equivalent within the last 4 weeks

          -  You had surgery on a joint that is to be assessed in the study within 2 months of
             study enrollment, or will require such during the study

          -  You have another serious disorder or illness

          -  You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or
             bone or joint infections) within the last 3 months

          -  You have a history of uncontrolled high blood pressure

          -  You have clinical laboratory test results at entry that are outside the normal
             reference range

          -  You are an employee of the clinic or you are an immediate family member of an employee
             of the clinic. Immediate family member is defined as a spouse, parent, child, or
             sibling, whether biological or legally adopted

          -  You are currently participating in or were discontinued within the last 30 days from
             another clinical trial involving an investigational drug

          -  If you are a woman and you could become pregnant during this study, you must talk to
             the study doctor about the birth control that you will use to avoid getting pregnant
             during the study.

          -  If you are a post-menopausal woman, you must be at least 45 years of age and have not
             menstruated for the last 12 months

          -  If you are a post-menopausal woman between 40 and 45 years of age, test negative for
             pregnancy, and have not menstruated during the last 12 months only, you must have an
             additional blood test to see if you can participate.

          -  If you are male, you must agree to reduce the risk of your female partner becoming
             pregnant during the study.

        Exclusions Specific to the bDMARD-naive Population:

          -  You have received any prior bDMARD therapy such as TNFα, Interleukin (IL)-1, IL-6,
             T-cell, or B-cell targeted therapies

          -  You have had an inadequate response to a minimum of 3 months of treatment with 5 or
             more conventional DMARDs [such as leflunomide, azathioprine, cyclosporine, etcetera
             (etc.)]

          -  You have used DMARDs other than MTX, hydroxychloroquine, or sulfasalazine within the
             last 8 weeks

          -  You have used leflunomide within the last 12 weeks and have not received
             cholestyramine to speed up the elimination of leflunomide from your body.

        Exclusions Specific to the TNFα-IR Population:

          -  You are currently using or recently used a bDMARD or a biologic TNFα inhibitor therapy
             within specified periods

          -  You have had a serious reaction to other biologic DMARDs that, in the study doctor's
             opinion, puts you at serious risk

          -  You have used cyclosporine or any other immunosuppressive in the 8 weeks before your
             participation in this study