Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
• Signs and/or symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to or more than prednisone 1 mg/kg daily orally for 2 weeks or intravenous (IV) for 1 week.
• Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally on 2 separate occasions.
• History of significant intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
• Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (AZA) (≥1.5 mg/kg/day) or 6-mercaptopurine (6-MP) mg/kg (≥1.0 mg/kg/day) or methotrexate (MTX) (≥10 mg/m^2 once a week).
• History of intolerance of at least 1 immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function test (LFT) abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, infection).
Tumor necrosis factor-alpha (TNF-α) antagonists:
• Signs and symptoms of persistently active disease despite a history of at least 1 induction regimen of infliximab 5 mg/kg IV at Week 0 and Weeks 2 and 6 or adalimumab 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15 if ≥40 kg or 80 mg on Day 1 and 40 mg on Day 15 if <40 kg. For any other TNF-α antagonist, the participant must demonstrate signs and symptoms of persistently active disease despite a history of at least 1 induction regimen, as determined by the investigator.
• Recurrence of symptoms during maintenance dosing following prior clinical benefit, i.e., fitting clinically with secondary loss of response (discontinuation despite clinical benefit does not qualify).
• History of intolerance of infliximab or adalimumab (including, but not limited to, infusion-related reaction, demyelination, congestive heart failure, infection).