Clinical trial NCT01313520 (phase 2, status: completed)
Conditions: arthritis, rheumatoid
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: infliximab, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Must have a clinical diagnosis of rheumatoid arthritis for at least 6 months

          -  Must have at least 6 tender joints AND 6 swollen joints

          -  Has a C-reactive protein ≥ 1.0 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr

          -  Baseline MRI must show evidence of synovitis in the wrist

          -  Must have screening laboratory tests within acceptable levels

          -  Women of childbearing potential and all men must agree to use a medically accepted
             method of contraception prior to entering the study and continue throughout study up
             to 6 weeks after study completion

          -  Must meet tuberculosis (TB) screening criteria

          -  Have received methotrexate therapy for ≥ 3 months; dose must be stable for at least 8
             weeks

          -  If taking the a disease modifying anti-rheumatic drug (DMARD) in combination with
             methotrexate must be on a stable dose

          -  Must have a clinically acceptable 12 lead electrocardiogram (ECG)

          -  If taking oral corticosteroids must be on a stable dose equivalent to ≤10 mg of
             prednisone (or prednisolone) per day for ≥2 weeks

          -  If taking daily non-steroidal anti-inflammatory drug (NSAID) must be on a stable dose
             for ≥2 weeks; if taking NSAID on an as-needed basis must agree to discontinue use for
             at least 3 days and use only acetaminophen for breakthrough pain for 3 days before
             each MRI and clinic visit

          -  If received biological therapies, the last dose of these drugs was to be received ≥ 3
             months prior to the baseline visit AND the reason for discontinuations was not for
             safety considerations OR lack of efficacy

        Exclusion Criteria:

          -  Are pregnant, intend to become pregnant, or are breastfeeding

          -  Has inflammatory arthritis other than RA

          -  Has uncontrolled hypertension

          -  Has moderate or severe congestive heart failure

          -  Has a history of or current signs and/or symptoms of severe, progressive, or
             uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
             cardiac, neurological, cerebral, or psychiatric disease

          -  Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis or
             optic neuritis

          -  Is currently participating in another clinical study or have participated in a
             clinical study (e.g., laboratory or clinical evaluation) within 4 weeks

          -  Has history of any tumor with the exception of adequately treated basal cell carcinoma
             or carcinoma in situ of the cervix

          -  Has a history of any latent or active granulomatous infection including
             histoplasmosis, or coccidiomycosis

          -  Had a non-tuberculous mycobacterial infection or opportunistic infection (e.g.
             cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months

          -  Has a history of an infected joint prosthesis which has not been removed or replaced

          -  Has a known hypersensitivity to human immunoglobulin proteins or other components of
             infliximab

          -  Has received rituximab or natalizumab

          -  Has known claustrophobia or other contraindication to MRI

          -  Does not meet washout period guidelines for previous
             treatments/injections/vaccinations