Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Baricitinib; Baricitinib; Baricitinib; Methotrexate
Intervention description: Administered orally as background therapy
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension),
      placebo-controlled, dose-ranging, parallel-group study of baricitinib (LY3009104) in Japanese
      participants with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.
      Baricitinib will be orally administered once a day with background methotrexate [6 to 16
      milligrams (mg)/week] therapy for 12 weeks in the double-blind treatment period (1, 2, 4 or 8
      mg/day, or placebo), and for 52 weeks in the single-blind extension period (4 or 8 mg/day).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory males or females between the ages of 20 and 75 years, inclusive, at time of
             study entry

          -  Diagnosis of adult-onset RA (of at least 6 months duration but not longer than 15
             years prior to screening) according to the 2010 American College of Rheumatology
             (ACR)/European League Against Rheumatism (EULAR) Responder Index classification
             criteria for RA

          -  Have active RA defined as at least 6 swollen and at least 6 tender joints based on the
             66/68 joint count

          -  Regular use of MTX for at least 12 weeks, and treatment at a stable dose of 6 to 16
             mg/week (2 or 3 times a week) for at least 8 weeks prior to the treatment period. The
             dose of MTX should remain stable throughout the study, but may be adjusted for safety
             reasons.

          -  For participants receiving corticosteroids, they must be on a dose not to exceed 10 mg
             of prednisone daily (or equivalent) and have been on the same dosing regimen for at
             least 6 weeks prior to the treatment period

          -  Have C-Reactive Protein (CRP) measurement > 0.5 milligrams/deciliter (mg/dL) or
             Erythrocyte Sedimentation Rate (ESR) > 28 millimeters/hour (mm/hr). The CRP and ESR
             may be repeated once during the screening period at the discretion of the
             investigator, and the repeat results may be accepted for study eligibility purposes

        Exclusion Criteria:

          -  Use of nonsteroidal anti-inflammatories (NSAIDs) for less than 4 weeks prior to the
             treatment period. If on NSAIDs, must be on a stable dose of the drug for at least 4
             weeks prior to the treatment period and must remain on a stable dose throughout the
             study

          -  Received prior treatment with an oral Janus Kinase (JAK) inhibitor regardless of when
             they received it

          -  Have a diagnosis of Felty's syndrome

          -  Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV
             antibodies

          -  Have hepatitis C virus (HCV; positive for anti-hepatitis C antibody with confirmed
             presence of HCV)

          -  Positive for hepatitis B surface antigen (HBsAg+), OR negative for hepatitis B surface
             antigen (HBsAg-), but positive for hepatitis B core antibody (HBcAb+) and/or positive
             for hepatitis B surface antibody (HBsAb+) with positive Hepatitis B virus
             (HBV)-deoxyribonucleic acid (DNA) [≥2.1 Log copy/mL by Polymerase Chain Reaction (PCR)
             method] detected in the serum

          -  Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test (QFT-G) or a
             purified protein derivative (PPD) test

          -  Have estimated Glomerular Filtration Rate (GFR) from serum creatinine using the
             Modification of Diet in Renal Disease (MDRD) method of <50 milliliter/minute (mL/min)