Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Withdrawal Due to Relapse of UC

Relapse is defined as withdrawal from the study due to lack of efficacy.

Time frame: Over 6 Months

Endoscopic Remission of UC With No or Mild Symptoms at 6 Months

Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Time frame: 6 Months

Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months

The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.

Time frame: Baseline and 6 months

Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score

Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.