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Methods – Study Design<br />
• These were Phase 2b, randomised, double-blind, placebo-controlled, parallel-group,<br />
multicentre studies<br />
• Eligible patients were randomised 1:1:1:1:1 to receive either placebo BID or<br />
immediate-release oral doses of ABT-494 at 3 mg, 6 mg, 12 mg or 18 mg BID for 12<br />
weeks<br />
– Study 1 included an additional dose of 24 mg once daily<br />
• Patients continued stable-dose MTX (7.5–25 mg/week) and were to take oral folic<br />
acid (or equivalent) from 4 weeks before baseline and throughout the study<br />
• Concurrent treatment was permitted with stable doses of other, non-DMARD<br />
background RA therapy<br />
• Patients who completed the 12-week randomised controlled study completed a<br />
30-day follow-up visit or had the option to enter an open-label extension study<br />
1. <strong>Genovese</strong> MC, et al. Arthritis Rheum 2016;68:2857–66.<br />
2. <strong>Kremer</strong> JM, et al. Arthritis Rheum 2016;68:2867–77.
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