A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

Time frame: Week 8

Population: Full analysis set (FAS): all participants who withdrew as treatment failure (TF) or completed \>=1 week dosing, had \>=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF=non-responders. Missing data due to reason other than TF were excluded. N (number of participants analyzed)=evaluable participants for the measure.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 4, 8

Population: FAS: all participants who either withdrew as TF or completed \>=1 week of dosing, had \>=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.

Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.

Time frame: Baseline, Week 2, 4, 8, 12

Population: FAS: all participants who either withdrew as TF or completed \>=1 week of dosing, had \>=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.

Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

Time frame: Baseline, Week 2, 4, 8, 12

Population: FAS: all participants who either withdrew as TF or completed \>=1 week of dosing, had \>=1 valid Mayo score during active double-blind phase. Baseline-observation-carried-forward (BOCF) was used for participants who withdrew as TF. Missing data due to reasons other than treatment failure were excluded. N=evaluable participants for the measure.

IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.

Time frame: Baseline, Week 8

Population: FAS: all participants who either withdrew as TF or completed \>=1 week of dosing, had \>=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.

Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

Time frame: Week 8

Population: FAS: all participants who either withdrew as treatment failure TF or completed \>=1 week dosing, had \>=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.

Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

Time frame: Week 8

Population: FAS: all participants who either withdrew as treatment failure TF or completed \>=1 week dosing, had \>=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.

Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

Time frame: Week 8

Population: FAS: all participants who either withdrew as treatment failure TF or completed \>=1 week dosing, had \>=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.

Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter \[ng/mL\]) to zero.

Time frame: 0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8

Population: Analysis population included all participants who had at least 1 plasma concentration. N=evaluable participants for this measure.