A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Baricitinib; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 290.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as baricitinib in participants with moderately to severely active rheumatoid arthritis
      who have had an inadequate response to methotrexate therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of adult-onset RA as defined by the ACR/European League Against
             Rheumatism (EULAR) 2010 Criteria for the Classification of RA.

          -  Have moderately to severely active RA defined as the presence of at least 6/68 tender
             joints and at least 6/66 swollen joints.

          -  Have a CRP (or hsCRP) measurement ≥ 6 mg/liter (L) based on the most recent data (if
             available).

          -  Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose
             that, in accordance with local clinical practice, is considered acceptable to
             adequately assess clinical response. The dose of MTX must have been a stable,
             unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at
             least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable
             throughout the study and may be adjusted only for safety reasons.

        Exclusion Criteria:

          -  Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or
             equivalent) or have been receiving an unstable dosing regimen of corticosteroids
             within 2 weeks of study entry or within 6 weeks of planned randomization.

          -  Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of
             planned randomization or have been receiving an unstable dosing regimen of NSAIDs
             within 2 weeks of study entry or within 6 weeks of planned randomization.

          -  Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and
             sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic
             drugs (cDMARDs).

          -  Are currently receiving or have received cDMARDs (for example, gold salts,
             cyclosporine, azathioprine, or any other immunosuppressives) other than MTX,
             hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8
             weeks prior to study entry.

          -  Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks
             prior to study entry if the standard 11 days of cholestyramine is used to washout
             leflunomide).

          -  Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry.

          -  Have ever received any biologic DMARD (such as tumor necrosis factor (TNF),
             interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies).

          -  Have received any parenteral corticosteroid administered by intramuscular or
             intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to
             planned randomization or are anticipated to require parenteral injection of
             corticosteroids during the study.

          -  Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic
             acid within 2 weeks prior to study entry or within 6 weeks prior to planned
             randomization.

          -  Have a diagnosis of any systemic inflammatory condition other than RA such as, but not
             limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,
             ulcerative colitis, psoriatic arthritis, active vasculitis or gout.

          -  Have an estimated glomerular filtration rate (eGFR) based on the most recent available
             serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of <40
             milliliters/minute/1.73 meters squared (m^2).

          -  Have a history of chronic liver disease with the most recent available aspartate
             aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of
             normal (ULN) or the most recent available total bilirubin 1.5 times the ULN.

          -  Have a current or recent (<30 days prior to study entry) clinically serious viral,
             bacterial, fungal, or parasitic infection.

          -  Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human
             immunodeficiency virus (HIV).

          -  Have had household contact with a person with active tuberculosis (TB) and did not
             receive appropriate and documented prophylaxis for TB.

          -  Have evidence of active TB or have previously had evidence of active TB and did not
             receive appropriate and documented treatment.

          -  Are pregnant or nursing at the time of study entry.

          -  Are females of childbearing potential who do not agree to use 2 forms of highly
             effective birth control when engaging in intercourse while enrolled in the study and
             for at least 28 days following the last dose of orally administered investigational
             product.

          -  Are males who do not agree to use 2 forms of highly effective birth control while
             engaging in sexual intercourse with female partners of childbearing potential while
             enrolled in the study and for at least 28 days following the last dose of orally
             administered investigational product.

          -  Have previously been randomized in this study or any other study investigating
             baricitinib.

          -  Have received prior treatment with an oral janus kinase inhibitor.