Patient selection: ulcerative colitis
Agent being evaluated: infliximab
Measure: Mayo score (see 10.17.06)
Parameters:
(1) individual components and the total Mayo score prior to therapy
(2) individual components and the total Mayo score after therapy
Criteria for clinical response:
(1) decrease in total score (pretreatment score minus posttreatment) after therapy >= 3
(2) decrease as a decimal fraction >= 0.3
(3) (decrease in rectal bleeding score >= 1) OR (rectal bleeding score after therapy <= 1)
decrease in the total score as a decimal fraction =
= ((pretreatment score) - (posttreatment score)) / (pretreatment score)
Criteria for clinical remission:
(1) total score after therapy <= 2
(2) all of the component scores (stool frequency, rectal bleeding, endoscopy, global assessment) <= 1
Criteria for mucosal healing:
(1) baseline endoscopy score >= 2
(2) endoscopy after therapy <= 1
