Clinical trial NCT01649999 (phase 2, status: completed)
Conditions: arthritis, rheumatoid
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: peficitinib, placebo
SMILES: NC(=O)C1=CN=C2NC=CC2=C1N[C@H]1[C@H]2CC3C[C@@H]1C[C@@](O)(C3)C2, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject has received a full explanation of the study drug and this study in advance,
             and written informed consent to participate in the study has been obtained from the
             subject himself/herself

          -  Outpatient has RA that was diagnosed according to the 1987 revised criteria of the ACR
             at least 6 months prior to screening

          -  At screening subject has active RA as evidenced by all of the following:

               -  ≥ 6 tender/painful joints;

               -  ≥ 6 swollen joints;

               -  CRP of ≥ 0.5 mg/dL or ESR of ≥ 28 mm/h.C-Reactive Protein (CRP) of ≥ 0.8 mg/dL or
                  Erythrocyte Sedimentation Rate (ESR) of ≥ 28 mm/hr

          -  Subject meets the ACR 1991 Revised Criteria for the Classification of Global
             Functional Status in RA, Class I, II or, III at screening

        Exclusion Criteria:

          -  Positive tuberculin (TB) test within 90 days of Screening

          -  Abnormal chest x-ray indicative of an acute or chronic infectious process or
             malignancy

          -  Receipt of live or live attenuated virus vaccination within 30 days prior to the first
             dose of study drug

          -  Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for
             human immunodeficiency virus (HIV) infection

          -  Any other autoimmune rheumatic disease, other than Sjogren's syndrome

          -  Previous history of clinically significant infections or illness (requiring
             hospitalization or requiring parenteral therapy) within 90 days of the Screening
             visit, or a history of any illness that would preclude participation in the study

          -  History of any malignancy, except for successfully treated basal or squamous cell
             carcinoma of the skin or in-situ carcinoma of the cervix

          -  Does not meet specified washout criteria for the following RA medications: etanercept,
             certolizumab, adalimumab, golimumab, infliximab and tocilizumab, rituximab, abatacept,
             anakinra, methotrexate, sulfasalazine, hydroxychloroquine, gold, penicillamine or
             leflunomide

          -  Previous intolerance to Janus kinase (JAK) inhibitors

          -  Receipt of intra-articular or parenteral corticosteroid within 28 days prior to the
             first dose of study drug

          -  Receipt of plasma exchange therapy within 60 days prior to the start of study drug

          -  Receipt of any investigational agent within 30 days or 5 half-lives, whichever is
             longer, prior to first dose of study drug

          -  Receipt of medications that are CYP3A substrates with narrow therapeutic range within
             14 days prior to first dose of study drug

          -  History of heart failure, defined as New York Heart Association (NYHA) grade 3 or
             greater