The purpose of this study of this study is to assess the responsiveness and validity of CIMS (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis) clinical disease activity by measuring:

The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of a treatment of known efficacy in UC.

This study will evaluate the responsiveness central reader based EIs for assessing clinical disease activity. Endoscopic images will be obtained from recent large multicenter randomized clinical trial and assessed using utilizing CIMS readers using EIs (MMCS, UCEIS, MBS) and a VAS (visual analog scale). The primary efficacy endpoint of this trial was clinical and endoscopic remission at week 6, with a secondary endpoint of endoscopic and clinical remission at week 10. For the same subjects, clinical data will be obtained including a modified UCDAI (Ulcerative Colitis Disease Activity Index). Central readers are blinded to clinical scores.

Inclusion Criteria:

• Active ulcerative colitis disease defined by the presence of a modified UCDAI score between 4 and 10
• Only patients who had an MMCS endoscopy subscale score according to a single reader
• Endoscopic videos recorded for CIMS based central reader assessment

Exclusion Criteria:

• UCDAI score less than 4 and greater than 10

The study population contained a broad spectrum of endoscopic and clinical activity. At entry patients had active disease defined by the presence of a modified UCDAI score between 4 and 10.