Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58.Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10.Remission was defined as having Grade 0 of 50% crypts involved) Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10.Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
The PGA score ranged from 0 to 3 with higher score indicating the severe disease. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease ), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA).
MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. Why Should I Register and Submit Results?.