Dataset from A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

This study was designed to evaluate if subjects who achieve complete remission after 8 weeks
of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term
outcomes and remain in remission longer compared with subjects who demonstrate only partial
remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore,
subjects who achieve either complete or partial remission will enter into a 12-month
maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given
QD. Remission status for the 2 groups will be evaluated and compared at the end of this
12-month maintenance period. The data obtained from this study will provide scientifically
meaningful information to demonstrate that achieving complete remission (clinical and
endoscopic remission) is important for a better long-term prognosis, or that the current
paradigm of symptomatic treatment is appropriate.