A Study in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2439821; Placebo
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of multiple doses of
      LY2439821 in Japanese patients with rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory male or female patients between the ages of 20 and 75 years

          -  Male patients: Agree to use a reliable method of birth control during the study
             including barrier contraceptives or a monogamous relationship with a partner who is
             not child bearing. Female patients: Are women who test negative for pregnancy at the
             time of entry based on a pregnancy test and are not breast feeding. Women of child
             bearing potential must agree to use a reliable method of birth control during the
             study.

          -  Patients who are between the body weight of 40 and 105 kilogram (kg)

          -  Patients who have an established diagnosis of Rheumatoid Arthritis (RA)

          -  Patients who have C reactive protein (CRP) measurement greater than the upper limit of
             normal or erythrocyte sedimentation rate of at least 28 millimeters per hour (mm/hr)

          -  Patients who have been treated with regular use of Methotrexate (MTX) for at least 12
             weeks, and stable treatment (at least 7.5 milligrams per week (mg/week)) for at least
             8 weeks

          -  Patients who have given written informed consent approved by the Sponsor and the
             Institutional Review Board (IRB) governing the investigational site

          -  Patients who have reliable and willing to make themselves available for the duration
             of the study and are willing to follow study procedures

        Exclusion Criteria:

          -  Patients who use oral corticosteroids at average daily doses of >10 mg/day of
             prednisone or its equivalent or use of variable doses of oral corticosteroids within
             the last 4 weeks

          -  Patients who have had a live vaccination within the last 12 weeks, or intend to have a
             live vaccination during the course of the study, or have participated in a vaccine
             clinical study within the last 12 weeks

          -  Patients who have a diagnosis of any systemic inflammatory condition other than RA

          -  Patients who have evidence of active vasculitis or uveitis

          -  Patients who have a diagnosis of Felty's syndrome

          -  Patients who have had surgical treatment of a joint within the last 8 weeks, or will
             require it during the study

          -  Patients who have had lymphoma, leukemia, or any malignancy within the last 5 years
             except for basal cell or squamous epithelial carcinomas of the skin that have been
             resected with no evidence of metastatic disease

          -  Patients who have suffered a serious bacterial infection within the last 12 weeks, or
             a recent or ongoing infection

          -  Patients who have an evidence or suspicion of active tuberculosis (TB) by medical
             history, physical examination, and/or chest radiograph or documentation of TB by a
             positive purified protein derivative (PPD) test

          -  Patients who have uncontrolled arterial hypertension characterized by a systolic blood
             pressure >160 mmHg or diastolic blood pressure >100 mmHg

          -  Patients who have an evidence of positive hepatitis B (HBV) surface antigen, positive
             hepatitis B surface antibody, positive hepatitis B core antibody, or hepatitis B DNA
             (HBV DNA); an evidence of human immunodeficiency virus (HIV), evidence of hepatitis B;
             or an evidence of hepatitis C

          -  Patients who have clinical laboratory test results at entry that are outside the
             normal reference range, or results with unacceptable deviations that are considered
             clinically significant by the investigator

          -  Patients who have a serum creatinine >2.0 milligrams per deciliter (mg/dL)

          -  Patients who have known hypogammaglobulinemia or a serum immunoglobulin (Ig) G (IgG),
             IgM, or IgA concentration less than the lower limit of normal

          -  Patients who have an abnormality in the 12 lead electrocardiogram (ECG).

          -  Patients who have donated of blood more than 200 mL within the past 30 days, or more
             than 400 milliliters (mL) within the past 90 days

          -  Patients who are currently enrolled in, or discontinued within the last 30 days from,
             a clinical trial involving an off label use of an investigational drug or device, or
             are concurrently enrolled in any other type of medical research judged not to be
             scientifically or medically compatible with this study. For unapproved
             Disease-Modifying Anti-Rheumatic Drug (DMARDs), have received 30 days or 5 fold of the
             half life prior to inclusion whichever is longer

          -  Patients who previously completed or withdrawn from this study or any other study
             investigating LY2439821

          -  Patients who have been treated with any biologic DMARD currently or previously for 5
             half lives

          -  Patients who have had serious reaction to other biologic Disease-Modifying
             Anti-Rheumatic Drug (DMARDs)

          -  Patients who have received non biologics DMARDs (other than MTX, sulfasalazine,
             bucillamine or hydroxychloroquine)