Clinical trial NCT01597739 (phase 2, status: completed)
Conditions: arthritis, rheumatoid
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: jnj-40346527, placebo
SMILES: CC1(C)CCC(=CC1)C1=C(NC(=O)C2=NC=C(N2)C#N)C=CC(=N1)C1CC(C)(C)OC(C)(C)C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis (RA) for at least 6 months prior to screening

          -  Have been positive for, or are positive at screening for, either anti-cyclic
             citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum

          -  Have active RA with at least 6 swollen and 6 tender joints, using a 66/68 joint count
             at the time of screening and at baseline, and serum C-reactive protein (CRP) >= 0.80
             mg/dL at screening

          -  Have been treated with and tolerated at least one of the following medications for a
             minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8
             weeks prior to screening: methotrexate (MTX) treatment at dosages of 7.5 to 25
             mg/week, inclusive; sulfasalazine not exceeding 3 g/d; hydroxychloroquine not
             exceeding 400 mg/d

          -  If using nonsteroidal antiinflammatory drugs (NSAIDs), or other analgesics regularly
             for RA, patients must have been on a stable dose for at least 2 weeks prior to the
             first administration of study agent. If not using NSAIDs or other analgesics for RA,
             the patient must have not received NSAIDs or other analgesics for at least 2 weeks
             prior to the first administration of study agent

          -  If using oral corticosteroids, must be on a stable dose of <= 10 mg/day of prednisone
             or an equipotent dose of another oral corticosteroid for at least 2 weeks prior to the
             first administration of study agent. If not using corticosteroids, the patient must
             have not received oral corticosteroids for at least 2 weeks prior to the first
             administration of study agent

        Exclusion Criteria:

          -  Has inflammatory diseases other than RA, including but not limited to adult onset
             Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus
             erythematosus, and Lyme disease that might confound the evaluation of the benefit of
             study agent therapy

          -  Has a history of juvenile idiopathic arthritis (JIA)

          -  Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular,
             pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or
             metabolic disturbances that are severe, progressive, or uncontrolled

          -  Has been treated in the time frames specified with any nonbiologic disease-modifying
             antirheumatic drugs (DMARDs), except for MTX, sulfasazine, and hydroxychloroquine,
             including, but not limited to: D-penicillamine, oral or parenteral gold salts,
             azathioprine, cyclosporine, tacrolimus, and mycophenolate mofetil within 4 weeks prior
             to the first administration of study agent; leflunomide within 12 weeks prior to the
             first administration of study agent unless the subject has undergone a drug
             elimination procedure at least 4 weeks prior to the first administration of study
             agent; any investigational nonbiologic DMARD within 4 weeks prior to the first
             administration of study agent or 5 half-lives of the DMARD, whichever is longer

          -  Has ever received any approved or investigational biologic antirheumatic agent. These
             agents include, but are not limited to, infliximab, golimumab, certolizumab pegol,
             etanercept, adalimumab, abatacept, rituximab, tocilizumab, or anakinra.

          -  Has received drugs that potently inhibit or induce cytochrome P450 (CYP450) 3A4,
             CYP2C8, or CYP2C19 isoforms within 2 weeks or within 5 half-lives of the drug,
             whichever is longer, prior to the first dose of study medication

          -  Has received intra-articular, epidural, intravertebral, intramuscular, or intravenous
             corticosteroids, including adrenocorticotropic hormone, within 4 weeks prior to the
             first dose of study medication