Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

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www.BMSStudyConnect.com

Inclusion Criteria:

- Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American
Rheumatism association (ARA) [1987] or American College of Rheumatology/European
League Against Rheumatism (ACR/EULAR) [2010]) at least 16 weeks prior to screening

- ACR global functional status class of 1 to 3

- Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors

- All subjects must have been receiving treatment with a minimum dose of 15 mg per week
of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to
screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be
reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per
week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is
permitted, if it is at a dose approved for the treatment of RA and the dose has been
stable for at least 28 days prior to screening

- Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at
baseline (Day 1)

- Elevated High-sensitivity (hs) CRP and/or ESR

Exclusion Criteria:

- Active serious infection

- History of or active tuberculosis (TB)

- Elevated liver function tests (LFTs)