ABT-494

Endoscopic remission was based on Simplified Endoscopic Score for Crohn's disease (SES-CD). The SES-CD assessed the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Endoscopic remission was defined as SES-CD ≤4 and at least two-point reduction versus Baseline of Study M13-740 and no subscore \>1 in any individual variable.

Clinical remission was defined as average daily stool frequency ≤1.5 and not worse than Baseline and average daily abdominal pain score ≤1.0 and not worse than baseline in Study M13-740. Abdominal pain was assessed using the CDAI component "abdominal pain" rated as none \[0\], mild \[1\], moderate \[2\], and severe \[3\]) (cumulative total over the past 7 days) as per the CDAI to calculate abdominal pain score; total score range from 0 to 105.

Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable.

Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).

Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.

Blood pressure, pulse rate and body temperature

Hematology, Chemistry, and Urinalysis

ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration

Cmax, Tmax, AUC, elimination rate constant and half-life