A Study of LY3462817 in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; LY3462817
Intervention description: Given IV; Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3462817 is safe and effective in
      participants with moderately to severely active rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of adult onset RA as defined by the 2010 American College of
             Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
             for at least 3 months prior to screening

          -  Have moderately to severely active RA defined by the presence of ≥6 swollen joints
             (based on 66 joint count) and ≥6 tender joints (based on 68 joint count) at screening
             and baseline. The distal interphalangeal joint should be evaluated but not included in
             the total count to determine eligibility

          -  Have at least 1 of the following:

               -  positive test results for rheumatoid factor or anti-citrullinated peptide
                  antibodies at screening, OR

               -  previous radiographs documenting bony erosions in hands or feet consistent with
                  RA

          -  Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central
             laboratory at screening

          -  Demonstrated an inadequate response to, or loss of response or intolerance to:

               -  at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)
                  treatment OR

               -  at least 1 biologic DMARD/tsDMARD treatment

        Exclusion Criteria:

          -  Class IV RA according to ACR revised response criteria

          -  Have a diagnosis or history of malignant disease within 5 years prior to baseline,
             with the exceptions of:

               -  basal cell or squamous epithelial carcinomas of the skin that have been resected
                  with no evidence of metastatic disease for 3 years, or

               -  cervical carcinoma in situ, with no evidence of recurrence within the 5 years
                  prior to baseline

          -  Have presence of confirmed cervical dysplasia

          -  Have had various types of infection within 3 months of screening or develops any of
             these infections before the randomization visit.

          -  Have any of the following:

               -  Human immunodeficiency virus (HIV) infection

               -  Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B
                  surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA

               -  Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)

               -  Active tuberculosis (TB)

          -  Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have
             received 2 bDMARDs and 1 tsDMARD)