A Study of LY3337641 in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY3337641; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in
      adults with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of childbearing potential test negative for pregnancy at screening and
             agree not to breastfeed

          -  Female subjects: agree to use a reliable method of birth control from the start of
             screening until 28 days after the last dose of study drug or be of nonchildbearing
             potential

          -  Male subjects: agree to use a reliable method of birth control from the start of
             screening until 2 weeks after the last dose of study drug or have undergone vasectomy

          -  Have a diagnosis of RA based on the 2010 American College of Rheumatology
             (ACR)/European League against Rheumatism criteria

          -  Have at least 1 of the following:

               -  rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR

               -  radiographs documenting bony erosions

          -  Have active RA, defined as:

               -  Part A: ≥3 swollen joints (based on 66-joint counts)

               -  Part B:

               -  ≥6 swollen joints (based on 66-joint counts)

               -  ≥6 tender joints (based on 68-joint counts)

               -  hsCRP levels greater than the upper limit of normal (ULN) OR positive for ACPA

          -  Part B only: Have had inadequate response, loss of response, or intolerance to at
             least 1 synthetic OR biologic disease-modifying antirheumatic drug (DMARD)

        Exclusion Criteria:

          -  Have received any of the following:

               -  Part B only: any prior treatment with a product directly targeting Bruton's
                  tyrosine kinase (BTK) (marketed or investigational)

               -  belimumab, natalizumab, or vedolizumab within 6 months prior to baseline

               -  B-cell-depleting agents (such as rituximab) or other cell-depleting biologics
                  (eg, anti-cluster of differentiation 3 (CD3) antibody) within 12 months prior to
                  screening for Part A or at any time prior to screening for Part B

          -  Have known hypogammaglobulinemia

          -  Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus

          -  Have active tuberculosis (TB)

          -  Are at high risk of infection or have recent evidence of clinically significant
             infection

          -  Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for
             treated basal cell or squamous epithelial carcinomas of the skin

          -  Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to
             receive one during the study