Ulcerative Colitis
Conditions
Brief summary
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
Interventions
DRUGPlacebo
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosis of Ulcerative Colitis for 3 or more months. * Ulcerative colitis must be active beyond the rectum. * Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points
Exclusion criteria
* Pregnant or breast feeding. * Diagnosis of indeterminate colitis or Crohn's Disease * Subjects with history of colonic or small bowel obstruction or resection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Clinical Remission at Week 12 | Week 12 | Clinical remission was defined as a Total Mayo Score of less than or equal (\<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Mucosal Healing at Week 12 | Week 12 | Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. |
| Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12 | Weeks 4, 8, and 12 | An absolute Partial Mayo Score of \<=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of absolute Partial Mayo Score \<=2, it was stated as change from baseline in Partial Mayo Score \<=2. |
| Change From Baseline in Total Mayo Score at Week 12 | Baseline, Week 12 | The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. |
| Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Baseline; Weeks (W) 4, 8, and 12 | The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (\<) 0, 0, and \>0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore. |
| Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Baseline, Week 12 | The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of \<0, 0, and \>0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore. |
| Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Baseline, Weeks 4, 8, and 12 | Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study. |
| Percentage of Participants With Clinical Response at Week 12 | Week 12 | Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Baseline, Week 12 | IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Baseline (BL), Week 12 | IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain. |
| Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12 | Week 12 | IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. 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 indicating better QOL. Positive change in total score indicated improvement in QOL. A score of \>=170 corresponds to clinical remission. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | Screening through to end of treatment period, up to 12 weeks | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Maximum Serum PF-00547659 Concentration Achieved | Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal | — |
| Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Baseline; Weeks 4, 8, and 12 | hsCRP was one of the PD biomarkers of the study. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, United States
Participant flow
Pre-assignment details
Two (2) subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead and were counted under that group. The numbers Started reflect the number of participants who received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh. | 73 |
| PF-00547659 7.5 mg Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh. | 71 |
| PF-00547659 22.5 mg Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh. | 70 |
| PF-00547659 75 mg Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh. | 73 |
| PF-00547659 225 mg Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh. | 70 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 | 0 | 1 | 1 |
| Overall Study | Non-compliance | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Participant underwent fecal transplant | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 1 | 2 | 4 |
| Overall Study | Withdrawn at discretion of investigator | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | PF-00547659 7.5 mg | PF-00547659 22.5 mg | PF-00547659 75 mg | PF-00547659 225 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 12.7 | 41.3 years STANDARD_DEVIATION 12.5 | 42.1 years STANDARD_DEVIATION 14.7 | 37.7 years STANDARD_DEVIATION 12.4 | 41.3 years STANDARD_DEVIATION 13.2 | 40.2 years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 25 Participants | 35 Participants | 28 Participants | 149 Participants |
| Sex: Female, Male Male | 44 Participants | 39 Participants | 45 Participants | 38 Participants | 42 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 73 | 16 / 71 | 15 / 70 | 14 / 73 | 18 / 70 |
| serious Total, serious adverse events | 4 / 73 | 11 / 71 | 2 / 70 | 4 / 73 | 3 / 70 |
Outcome results
Primary
Percentage of Participants in Clinical Remission at Week 12
Clinical remission was defined as a Total Mayo Score of less than or equal (\<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time frame: Week 12
Population: The primary analysis population was based on a modified intent-to-treat (mITT) analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants in Clinical Remission at Week 12 | Centrally read | 2.7 percentage of participants |
| Placebo | Percentage of Participants in Clinical Remission at Week 12 | Locally read | 5.5 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants in Clinical Remission at Week 12 | Locally read | 14.1 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants in Clinical Remission at Week 12 | Centrally read | 11.3 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants in Clinical Remission at Week 12 | Locally read | 23.6 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants in Clinical Remission at Week 12 | Centrally read | 16.7 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants in Clinical Remission at Week 12 | Centrally read | 15.5 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants in Clinical Remission at Week 12 | Locally read | 18.3 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants in Clinical Remission at Week 12 | Locally read | 12.9 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants in Clinical Remission at Week 12 | Centrally read | 5.7 percentage of participants |
Comparison: PF-00547659 7.5 mg versus (vs) placebo, centrally readp-value: 0.021390% CI: [0.019, 0.14]Cochran-Mantel-Haenszel
Comparison: PF-00547659 22.5 mg vs placebo, centrally readp-value: 0.002590% CI: [0.056, 0.199]Cochran-Mantel-Haenszel
Comparison: PF-00547659 75 mg vs placebo, centrally readp-value: 0.00490% CI: [0.048, 0.188]Cochran-Mantel-Haenszel
Comparison: PF-00547659 225 mg vs placebo, centrally readp-value: 0.180390% CI: [-0.012, 0.064]Cochran-Mantel-Haenszel
Comparison: PF-00547659 7.5 mg vs placebo, locally readp-value: 0.058290% CI: [0.002, 0.159]Cochran-Mantel-Haenszel
Comparison: PF-00547659 22.5 mg vs placebo, locally readp-value: 0.001490% CI: [0.083, 0.272]Cochran-Mantel-Haenszel
Comparison: PF-00547659 75 mg vs placebo, locally readp-value: 0.012590% CI: [0.036, 0.208]Cochran-Mantel-Haenszel
Comparison: PF-00547659 225 mg vs placebo, locally readp-value: 0.092790% CI: [-0.009, 0.142]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12
IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.
Time frame: Baseline (BL), Week 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point for that specific domain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, bowel fx (n=62,55,61,64,54) | 7.4 units on a scale | Standard Deviation 11.93 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, emotional fx (n=69,68,65,71,66) | 50.4 units on a scale | Standard Deviation 12.6 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, bowel fx (n=69,68,65,71,66) | 38.9 units on a scale | Standard Deviation 9.96 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, emotional fx (n=62,55,61,64,54) | 5.9 units on a scale | Standard Deviation 11.91 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, SS (n=62,55,61,64,54) | 3.3 units on a scale | Standard Deviation 6.67 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, social fx (n=62,55,61,64,54) | 3.3 units on a scale | Standard Deviation 6.27 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, systemic symptoms (SS)(n=69,68,65,71,66) | 18.1 units on a scale | Standard Deviation 5.62 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, social fx (n=69,68,65,71,66) | 20.6 units on a scale | Standard Deviation 7.87 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, emotional fx (n=69,68,65,71,66) | 48.4 units on a scale | Standard Deviation 15.39 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, emotional fx (n=62,55,61,64,54) | 6.6 units on a scale | Standard Deviation 12.22 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, bowel fx (n=69,68,65,71,66) | 37.0 units on a scale | Standard Deviation 12.23 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, social fx (n=62,55,61,64,54) | 3.6 units on a scale | Standard Deviation 7.33 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, systemic symptoms (SS)(n=69,68,65,71,66) | 18.2 units on a scale | Standard Deviation 6.81 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, SS (n=62,55,61,64,54) | 3.1 units on a scale | Standard Deviation 5.95 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, social fx (n=69,68,65,71,66) | 18.5 units on a scale | Standard Deviation 8.07 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, bowel fx (n=62,55,61,64,54) | 6.9 units on a scale | Standard Deviation 12.51 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, social fx (n=62,55,61,64,54) | 5.9 units on a scale | Standard Deviation 6.51 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, SS (n=62,55,61,64,54) | 4.7 units on a scale | Standard Deviation 5.91 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, emotional fx (n=69,68,65,71,66) | 51.2 units on a scale | Standard Deviation 14.7 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, emotional fx (n=62,55,61,64,54) | 10.8 units on a scale | Standard Deviation 13.85 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, social fx (n=69,68,65,71,66) | 20.9 units on a scale | Standard Deviation 7.37 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, bowel fx (n=62,55,61,64,54) | 11.3 units on a scale | Standard Deviation 11.05 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, systemic symptoms (SS)(n=69,68,65,71,66) | 19.6 units on a scale | Standard Deviation 5.98 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, bowel fx (n=69,68,65,71,66) | 41.7 units on a scale | Standard Deviation 10.6 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, emotional fx (n=69,68,65,71,66) | 50.4 units on a scale | Standard Deviation 13.73 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, emotional fx (n=62,55,61,64,54) | 10.0 units on a scale | Standard Deviation 12.04 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, bowel fx (n=69,68,65,71,66) | 38.5 units on a scale | Standard Deviation 9.95 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, systemic symptoms (SS)(n=69,68,65,71,66) | 18.4 units on a scale | Standard Deviation 6.42 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, social fx (n=62,55,61,64,54) | 5.4 units on a scale | Standard Deviation 6.9 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, SS (n=62,55,61,64,54) | 4.9 units on a scale | Standard Deviation 5.49 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, social fx (n=69,68,65,71,66) | 20.7 units on a scale | Standard Deviation 6.99 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, bowel fx (n=62,55,61,64,54) | 11.8 units on a scale | Standard Deviation 12.07 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, social fx (n=69,68,65,71,66) | 20.9 units on a scale | Standard Deviation 7.73 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, social fx (n=62,55,61,64,54) | 6.6 units on a scale | Standard Deviation 6.58 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, emotional fx (n=69,68,65,71,66) | 51.3 units on a scale | Standard Deviation 15.92 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, SS (n=62,55,61,64,54) | 4.8 units on a scale | Standard Deviation 5.05 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, systemic symptoms (SS)(n=69,68,65,71,66) | 19.0 units on a scale | Standard Deviation 5.97 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, bowel fx (n=62,55,61,64,54) | 12.8 units on a scale | Standard Deviation 11.45 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | BL, bowel fx (n=69,68,65,71,66) | 41.0 units on a scale | Standard Deviation 11.37 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Change at W12, emotional fx (n=62,55,61,64,54) | 12.0 units on a scale | Standard Deviation 11.4 |
Comparison: PF-00547659 7.5 mg vs placebo, bowel fx change from BL at W12p-value: 0.686290% CI: [-3.689, 2.235]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, bowel fx change from BL at W12p-value: 0.013590% CI: [1.467, 7.28]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, bowel fx change from BL at W12p-value: 0.017190% CI: [1.293, 7.023]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, bowel fx change from BL at W12p-value: 0.004190% CI: [2.232, 8.172]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, emotional fx change from BL at W12p-value: 0.907290% CI: [-2.897, 3.339]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, emotional fx change from BL at W12p-value: 0.016190% CI: [1.42, 7.522]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, emotional fx change from BL at W12p-value: 0.00290% CI: [2.778, 9.026]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, emotional fx change from BL at W12p-value: 0.027190% CI: [1.042, 7.071]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, systemic symptoms change from BL at W12p-value: 0.771190% CI: [-1.756, 1.229]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, systemic symptoms change from BL at W12p-value: 0.058290% CI: [0.223, 3.147]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, systemic symptoms change from BL at W12p-value: 0.055890% CI: [0.235, 3.12]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, systemic symptoms change from BL at W12p-value: 0.068690% CI: [0.161, 3.153]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, social fx change from BL at W12p-value: 0.756190% CI: [-2.094, 1.429]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, social fx change from BL at W12p-value: 0.038490% CI: [0.447, 3.891]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, social fx change from BL at W12p-value: 0.072990% CI: [0.154, 3.557]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, social fx change from BL at W12p-value: 0.00690% CI: [1.19, 4.715]Mixed Models Analysis
Secondary
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.
Time frame: Baseline, Week 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Baseline (BL)(n=69,68,65,71,66) | 128.0 units on a scale | Standard Deviation 30.69 |
| Placebo | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Change at W12 (n=62,55,61,64,54) | 19.8 units on a scale | Standard Deviation 34.08 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Change at W12 (n=62,55,61,64,54) | 20.1 units on a scale | Standard Deviation 35.24 |
| PF-00547659 7.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Baseline (BL)(n=69,68,65,71,66) | 122.1 units on a scale | Standard Deviation 38.82 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Change at W12 (n=62,55,61,64,54) | 32.7 units on a scale | Standard Deviation 34.1 |
| PF-00547659 22.5 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Baseline (BL)(n=69,68,65,71,66) | 133.4 units on a scale | Standard Deviation 34.79 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Baseline (BL)(n=69,68,65,71,66) | 128.0 units on a scale | Standard Deviation 32.42 |
| PF-00547659 75 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Change at W12 (n=62,55,61,64,54) | 32.1 units on a scale | Standard Deviation 31.7 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Change at W12 (n=62,55,61,64,54) | 36.2 units on a scale | Standard Deviation 29.45 |
| PF-00547659 225 mg | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Baseline (BL)(n=69,68,65,71,66) | 132.3 units on a scale | Standard Deviation 36.84 |
Comparison: PF-00547659 7.5 mg vs placebo, change from BL at W12p-value: 0.830290% CI: [-9.507, 7.317]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, change from BL at W12p-value: 0.014190% CI: [4.084, 20.567]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, change from BL at W12p-value: 0.018290% CI: [3.564, 19.84]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, change from BL at W12p-value: 0.002690% CI: [7.056, 23.907]Mixed Models Analysis
Secondary
Change From Baseline in Total Mayo Score at Week 12
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time frame: Baseline, Week 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants in that specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Mayo Score at Week 12 | Centrally read change (n=67,63,69,67,63) | -1.5 units on a scale | Standard Deviation 2.42 |
| Placebo | Change From Baseline in Total Mayo Score at Week 12 | Locally read change (n=67,62,70,66,64) | -1.7 units on a scale | Standard Deviation 2.55 |
| Placebo | Change From Baseline in Total Mayo Score at Week 12 | Locally read baseline (n=73,70,72,70,70) | 8.4 units on a scale | Standard Deviation 1.72 |
| Placebo | Change From Baseline in Total Mayo Score at Week 12 | Centrally read baseline (n=73,71,72,71,70) | 8.4 units on a scale | Standard Deviation 1.71 |
| PF-00547659 7.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read change (n=67,62,70,66,64) | -2.7 units on a scale | Standard Deviation 3.05 |
| PF-00547659 7.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read change (n=67,63,69,67,63) | -2.4 units on a scale | Standard Deviation 2.78 |
| PF-00547659 7.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read baseline (n=73,71,72,71,70) | 8.7 units on a scale | Standard Deviation 1.65 |
| PF-00547659 7.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read baseline (n=73,70,72,70,70) | 8.8 units on a scale | Standard Deviation 1.59 |
| PF-00547659 22.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read change (n=67,63,69,67,63) | -2.9 units on a scale | Standard Deviation 2.49 |
| PF-00547659 22.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read baseline (n=73,71,72,71,70) | 8.1 units on a scale | Standard Deviation 1.63 |
| PF-00547659 22.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read change (n=67,62,70,66,64) | -3.1 units on a scale | Standard Deviation 2.7 |
| PF-00547659 22.5 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read baseline (n=73,70,72,70,70) | 8.1 units on a scale | Standard Deviation 1.72 |
| PF-00547659 75 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read baseline (n=73,71,72,71,70) | 8.4 units on a scale | Standard Deviation 1.94 |
| PF-00547659 75 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read change (n=67,63,69,67,63) | -2.5 units on a scale | Standard Deviation 2.74 |
| PF-00547659 75 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read baseline (n=73,70,72,70,70) | 8.3 units on a scale | Standard Deviation 1.99 |
| PF-00547659 75 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read change (n=67,62,70,66,64) | -2.7 units on a scale | Standard Deviation 2.92 |
| PF-00547659 225 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read change (n=67,62,70,66,64) | -3.1 units on a scale | Standard Deviation 3.07 |
| PF-00547659 225 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read baseline (n=73,71,72,71,70) | 8.7 units on a scale | Standard Deviation 1.6 |
| PF-00547659 225 mg | Change From Baseline in Total Mayo Score at Week 12 | Centrally read change (n=67,63,69,67,63) | -2.9 units on a scale | Standard Deviation 2.78 |
| PF-00547659 225 mg | Change From Baseline in Total Mayo Score at Week 12 | Locally read baseline (n=73,70,72,70,70) | 8.6 units on a scale | Standard Deviation 1.62 |
Comparison: PF-00547659 225 mg vs placebo, centrally read changep-value: 0.004990% CI: [-2.016, -0.533]ANCOVA
Comparison: PF-00547659 7.5 mg vs placebo, locally read changep-value: 0.054390% CI: [-1.737, -0.137]ANCOVA
Comparison: PF-00547659 22.5 mg vs placebo, locally read changep-value: 0.000890% CI: [-2.372, -0.819]ANCOVA
Comparison: PF-00547659 75 mg vs placebo, locally read changep-value: 0.025590% CI: [-1.858, -0.284]ANCOVA
Comparison: PF-00547659 225 mg vs placebo, locally read changep-value: 0.007990% CI: [-2.082, -0.493]ANCOVA
Comparison: PF-00547659 7.5 mg vs placebo, centrally read changep-value: 0.049490% CI: [-1.623, -0.145]ANCOVA
Comparison: PF-00547659 22.5 mg vs placebo, centrally read changep-value: 0.000590% CI: [-2.254, -0.809]ANCOVA
Comparison: PF-00547659 75 mg vs placebo, centrally read changep-value: 0.011790% CI: [-1.845, -0.39]ANCOVA
Secondary
Maximum Serum PF-00547659 Concentration Achieved
Time frame: Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal
Population: Participants who received active treatment (PF-00547659) were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-00547659 7.5 mg | Maximum Serum PF-00547659 Concentration Achieved | 929.4 nanograms (ng)/milliliter (mL) | Standard Deviation 1977.8 |
| PF-00547659 22.5 mg | Maximum Serum PF-00547659 Concentration Achieved | 2062 nanograms (ng)/milliliter (mL) | Standard Deviation 1395.5 |
| PF-00547659 75 mg | Maximum Serum PF-00547659 Concentration Achieved | 6576 nanograms (ng)/milliliter (mL) | Standard Deviation 2146 |
| PF-00547659 225 mg | Maximum Serum PF-00547659 Concentration Achieved | 21470 nanograms (ng)/milliliter (mL) | Standard Deviation 4788.4 |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening through to end of treatment period, up to 12 weeks
Population: All randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With SAEs | 4 participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With TEAEs | 39 participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | Withdrawals due to TEAEs | 2 participants |
| PF-00547659 7.5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With SAEs | 11 participants |
| PF-00547659 7.5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | Withdrawals due to TEAEs | 5 participants |
| PF-00547659 7.5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With TEAEs | 41 participants |
| PF-00547659 22.5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With TEAEs | 36 participants |
| PF-00547659 22.5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | Withdrawals due to TEAEs | 0 participants |
| PF-00547659 22.5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With SAEs | 1 participants |
| PF-00547659 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With TEAEs | 43 participants |
| PF-00547659 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | Withdrawals due to TEAEs | 3 participants |
| PF-00547659 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With SAEs | 3 participants |
| PF-00547659 225 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With SAEs | 3 participants |
| PF-00547659 225 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | With TEAEs | 43 participants |
| PF-00547659 225 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | Withdrawals due to TEAEs | 1 participants |
Secondary
Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12
An absolute Partial Mayo Score of \<=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of absolute Partial Mayo Score \<=2, it was stated as change from baseline in Partial Mayo Score \<=2.
Time frame: Weeks 4, 8, and 12
Population: As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented.
Secondary
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12
IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. 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 indicating better QOL. Positive change in total score indicated improvement in QOL. A score of \>=170 corresponds to clinical remission.
Time frame: Week 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12 | 36.9 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12 | 36.8 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12 | 55.6 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12 | 46.9 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12 | 48.1 percentage of participants |
Comparison: PF-00547659 7.5 mg vs placebop-value: 0.520190% CI: [-0.145, 0.142]Cochran-Mantel-Haenszel
Comparison: PF-00547659 22.5 mg vs placebop-value: 0.021790% CI: [0.039, 0.328]Cochran-Mantel-Haenszel
Comparison: PF-00547659 75 mg vs placebop-value: 0.147390% CI: [-0.045, 0.237]Cochran-Mantel-Haenszel
Comparison: PF-00547659 225 mg vs placebop-value: 0.123190% CI: [-0.038, 0.261]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of \<0, 0, and \>0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.
Time frame: Baseline, Week 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Imp (n=67,63,69,67,63) | 25.37 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | NC (n=67,63,69,67,63) | 61.19 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Wors (n=67,63,69,67,63) | 13.43 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Wors (n=67,63,69,67,63) | 11.11 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Imp (n=67,63,69,67,63) | 28.57 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | NC (n=67,63,69,67,63) | 60.32 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Wors (n=67,63,69,67,63) | 2.90 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | NC (n=67,63,69,67,63) | 49.28 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Imp (n=67,63,69,67,63) | 47.83 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | NC (n=67,63,69,67,63) | 46.27 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Wors (n=67,63,69,67,63) | 5.97 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Imp (n=67,63,69,67,63) | 47.76 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Wors (n=67,63,69,67,63) | 3.17 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | NC (n=67,63,69,67,63) | 57.14 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Imp (n=67,63,69,67,63) | 39.68 percentage of participants |
Comparison: PF-00547659 7.5 mg vs placebop-value: 0.540690% CI: [-0.286, 0.131]ANCOVA
Comparison: PF-00547659 22.5 mg vs placebop-value: 0.000790% CI: [-0.628, -0.221]ANCOVA
Comparison: PF-00547659 75 mg vs placebop-value: 0.006390% CI: [-0.549, -0.137]ANCOVA
Comparison: PF-00547659 225 mg vs placebop-value: 0.074890% CI: [-0.436, -0.018]ANCOVA
Secondary
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (\<) 0, 0, and \>0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.
Time frame: Baseline; Weeks (W) 4, 8, and 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point for that endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W4 (n=67,64,71,69,65) | 13.43 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W4 (n=67,64,71,69,65) | 59.70 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W4 (n=67,64,71,69,65) | 26.87 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W4 (n=67,64,71,69,65) | 2.99 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W12 (n=67,63,71,68,64) | 35.82 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W8 (n=71,63,71,69,68) | 7.04 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W12 (n=67,63,71,68,64) | 50.75 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W8 (n=71,63,71,69,68) | 60.56 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W8 (n=71,63,71,69,68) | 59.15 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W4 (n=67,64,71,69,65) | 49.25 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W4 (n=67,64,71,69,65) | 47.76 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W12 (n=67,63,71,68,64) | 11.94 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W4 (n=67,64,71,69,65) | 22.39 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W12 (n=67,63,71,68,64) | 5.97 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W12 (n=67,63,71,68,64) | 50.75 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W12 (n=67,63,71,68,64) | 37.31 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W8 (n=71,63,71,69,68) | 11.27 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W4 (n=67,64,71,69,65) | 62.69 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W12 (n=67,63,71,68,64) | 43.28 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W8 (n=71,63,71,69,68) | 54.93 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W8 (n=71,63,71,69,68) | 33.80 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W4 (n=67,64,71,69,65) | 14.93 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W8 (n=71,63,71,69,68) | 33.80 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W12 (n=67,63,71,68,64) | 11.94 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W12 (n=67,63,71,68,64) | 52.24 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W8 (n=71,63,71,69,68) | 11.27 percentage of participants |
| Placebo | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W8 (n=71,63,71,69,68) | 28.17 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W4 (n=67,64,71,69,65) | 10.94 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W8 (n=71,63,71,69,68) | 42.86 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W12 (n=67,63,71,68,64) | 49.21 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W4 (n=67,64,71,69,65) | 48.44 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W4 (n=67,64,71,69,65) | 42.19 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W4 (n=67,64,71,69,65) | 9.38 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W4 (n=67,64,71,69,65) | 7.81 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W12 (n=67,63,71,68,64) | 61.90 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W4 (n=67,64,71,69,65) | 46.88 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W4 (n=67,64,71,69,65) | 42.19 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W8 (n=71,63,71,69,68) | 49.21 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W8 (n=71,63,71,69,68) | 7.94 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W12 (n=67,63,71,68,64) | 41.27 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W12 (n=67,63,71,68,64) | 9.52 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W8 (n=71,63,71,69,68) | 50.79 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W8 (n=71,63,71,69,68) | 36.51 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W8 (n=71,63,71,69,68) | 12.70 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W12 (n=67,63,71,68,64) | 53.97 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W12 (n=67,63,71,68,64) | 34.92 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W12 (n=67,63,71,68,64) | 11.11 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W4 (n=67,64,71,69,65) | 57.81 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W4 (n=67,64,71,69,65) | 34.38 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W8 (n=71,63,71,69,68) | 61.90 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W8 (n=71,63,71,69,68) | 30.16 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W8 (n=71,63,71,69,68) | 7.94 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W12 (n=67,63,71,68,64) | 31.75 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W12 (n=67,63,71,68,64) | 6.35 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W8 (n=71,63,71,69,68) | 50.70 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W8 (n=71,63,71,69,68) | 53.52 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W12 (n=67,63,71,68,64) | 56.34 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W4 (n=67,64,71,69,65) | 4.23 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W4 (n=67,64,71,69,65) | 56.34 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W12 (n=67,63,71,68,64) | 7.04 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W12 (n=67,63,71,68,64) | 2.82 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W12 (n=67,63,71,68,64) | 38.03 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W8 (n=71,63,71,69,68) | 43.66 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W12 (n=67,63,71,68,64) | 32.39 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W4 (n=67,64,71,69,65) | 42.25 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W8 (n=71,63,71,69,68) | 8.45 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W12 (n=67,63,71,68,64) | 42.25 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W8 (n=71,63,71,69,68) | 2.82 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W12 (n=67,63,71,68,64) | 5.63 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W4 (n=67,64,71,69,65) | 39.44 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W4 (n=67,64,71,69,65) | 36.62 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W4 (n=67,64,71,69,65) | 0 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W12 (n=67,63,71,68,64) | 50.70 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W8 (n=71,63,71,69,68) | 66.20 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W4 (n=67,64,71,69,65) | 60.56 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W8 (n=71,63,71,69,68) | 2.82 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W8 (n=71,63,71,69,68) | 40.85 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W8 (n=71,63,71,69,68) | 30.99 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W4 (n=67,64,71,69,65) | 2.82 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W4 (n=67,64,71,69,65) | 57.75 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W12 (n=67,63,71,68,64) | 64.79 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W8 (n=71,63,71,69,68) | 49.28 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W8 (n=71,63,71,69,68) | 46.38 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W8 (n=71,63,71,69,68) | 8.70 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W12 (n=67,63,71,68,64) | 48.53 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W4 (n=67,64,71,69,65) | 4.35 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W4 (n=67,64,71,69,65) | 53.62 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W8 (n=71,63,71,69,68) | 0 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W8 (n=71,63,71,69,68) | 46.38 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W8 (n=71,63,71,69,68) | 44.93 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W4 (n=67,64,71,69,65) | 42.03 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W8 (n=71,63,71,69,68) | 4.35 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W12 (n=67,63,71,68,64) | 47.06 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W12 (n=67,63,71,68,64) | 4.41 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W12 (n=67,63,71,68,64) | 45.59 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W12 (n=67,63,71,68,64) | 5.88 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W12 (n=67,63,71,68,64) | 39.71 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W4 (n=67,64,71,69,65) | 56.52 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W12 (n=67,63,71,68,64) | 45.59 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W4 (n=67,64,71,69,65) | 1.45 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W8 (n=71,63,71,69,68) | 62.32 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W12 (n=67,63,71,68,64) | 55.88 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W4 (n=67,64,71,69,65) | 42.03 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W4 (n=67,64,71,69,65) | 30.43 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W4 (n=67,64,71,69,65) | 63.77 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W4 (n=67,64,71,69,65) | 5.80 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W12 (n=67,63,71,68,64) | 7.35 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W8 (n=71,63,71,69,68) | 37.68 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W8 (n=71,63,71,69,68) | 48.53 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W4 (n=67,64,71,69,65) | 4.62 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W8 (n=71,63,71,69,68) | 33.82 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W8 (n=71,63,71,69,68) | 64.71 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W4 (n=67,64,71,69,65) | 6.15 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W4 (n=67,64,71,69,65) | 52.31 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W8 (n=71,63,71,69,68) | 67.65 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W8 (n=71,63,71,69,68) | 1.47 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W8 (n=71,63,71,69,68) | 0 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W12 (n=67,63,71,68,64) | 3.13 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W8 (n=71,63,71,69,68) | 51.47 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in PGA, W12 (n=67,63,71,68,64) | 9.38 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W4 (n=67,64,71,69,65) | 44.62 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W4 (n=67,64,71,69,65) | 4.62 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Rectal Bleeding, W12 (n=67,63,71,68,64) | 35.94 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W4 (n=67,64,71,69,65) | 43.08 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W12 (n=67,63,71,68,64) | 60.94 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Rectal Bleeding, W8 (n=71,63,71,69,68) | 1.47 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in Stool frequency, W12 (n=67,63,71,68,64) | 37.50 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Wors in Stool frequency, W12 (n=67,63,71,68,64) | 6.25 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W12 (n=67,63,71,68,64) | 57.81 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Stool frequency, W12 (n=67,63,71,68,64) | 56.25 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in PGA, W4 (n=67,64,71,69,65) | 60.00 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W8 (n=71,63,71,69,68) | 30.88 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W12 (n=67,63,71,68,64) | 32.81 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | NC in PGA, W4 (n=67,64,71,69,65) | 35.38 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 | Imp in Rectal Bleeding, W4 (n=67,64,71,69,65) | 49.23 percentage of participants |
Comparison: PF-00547659 7.5 mg vs placebo, Stool Frequency, W4p-value: 0.101690% CI: [-0.511, 0.001]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Stool Frequency, W4p-value: 0.065490% CI: [-0.529, -0.03]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Stool Frequency, W4p-value: 0.1590% CI: [-0.472, 0.031]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Stool Frequency, W4p-value: 0.013290% CI: [-0.637, -0.129]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Stool Frequency, W8p-value: 0.052690% CI: [-0.555, -0.046]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Stool Frequency, W8p-value: 0.042290% CI: [-0.554, -0.058]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Stool Frequency, W8p-value: 0.01190% CI: [-0.637, -0.137]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Stool Frequency, W8p-value: 0.00190% CI: [-0.755, -0.254]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Stool Frequency, W12p-value: 0.161190% CI: [-0.475, 0.038]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Stool Frequency, W12p-value: 0.018690% CI: [-0.608, -0.108]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Stool Frequency, W12p-value: 0.164790% CI: [-0.465, 0.039]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Stool Frequency, W12p-value: 0.023190% CI: [-0.607, -0.097]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4p-value: 0.000290% CI: [-0.658, -0.26]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4p-value: <0.000190% CI: [-0.71, -0.322]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Rectal Bleeding, W4p-value: <0.000190% CI: [-0.686, -0.295]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Rectal Bleeding, W4p-value: 0.001290% CI: [-0.587, -0.192]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8p-value: 0.020790% CI: [-0.475, -0.081]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8p-value: 0.040290% CI: [-0.432, -0.048]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Rectal Bleeding, W8p-value: 0.007190% CI: [-0.511, -0.124]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Rectal Bleeding, W8p-value: <0.000190% CI: [-0.664, -0.275]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12p-value: 0.039590% CI: [-0.449, -0.05]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12p-value: 0.007390% CI: [-0.511, -0.123]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Rectal Bleeding, W12p-value: 0.041390% CI: [-0.439, -0.047]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Rectal Bleeding, W12p-value: 0.000890% CI: [-0.602, -0.206]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, PGA, W4p-value: 0.186290% CI: [-0.421, 0.046]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, PGA, W4p-value: 0.099890% CI: [-0.455, 0]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, PGA, W4p-value: 0.108590% CI: [-0.453, 0.006]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, PGA, W4p-value: 0.316190% CI: [-0.372, 0.09]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, PGA, W8p-value: 0.496290% CI: [-0.328, 0.136]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, PGA, W8p-value: 0.037190% CI: [-0.512, -0.06]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, PGA, W8p-value: 0.121290% CI: [-0.441, 0.013]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, PGA, W8p-value: 0.18790% CI: [-0.41, 0.045]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, PGA, W12p-value: 0.113390% CI: [-0.459, 0.009]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, PGA, W12p-value: 0.002290% CI: [-0.653, -0.198]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, PGA, W12p-value: 0.078890% CI: [-0.475, -0.016]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, PGA, W12p-value: 0.071790% CI: [-0.485, -0.022]Mixed Models Analysis
Secondary
Percentage of Participants With Clinical Response at Week 12
Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time frame: Week 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of participants evaluable for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Clinical Response at Week 12 | Centrally read (n=73,71,72,71,70) | 28.8 percentage of participants |
| Placebo | Percentage of Participants With Clinical Response at Week 12 | Locally read (n=73,70,72,70,70) | 32.9 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Clinical Response at Week 12 | Locally read (n=73,70,72,70,70) | 38.6 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Clinical Response at Week 12 | Centrally read (n=73,71,72,71,70) | 38.0 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Clinical Response at Week 12 | Centrally read (n=73,71,72,71,70) | 54.2 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Clinical Response at Week 12 | Locally read (n=73,70,72,70,70) | 54.2 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Clinical Response at Week 12 | Locally read (n=73,70,72,70,70) | 48.6 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Clinical Response at Week 12 | Centrally read (n=73,71,72,71,70) | 45.1 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Clinical Response at Week 12 | Locally read (n=73,70,72,70,70) | 51.4 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Clinical Response at Week 12 | Centrally read (n=73,71,72,71,70) | 50.0 percentage of participants |
Comparison: PF-00547659 7.5 mg vs placebo, centrally readp-value: 0.137990% CI: [-0.037, 0.214]Cochran-Mantel-Haenszel
Comparison: PF-00547659 22.5 mg vs placebo, centrally readp-value: 0.001190% CI: [0.121, 0.388]Cochran-Mantel-Haenszel
Comparison: PF-00547659 75 mg vs placebo, centrally readp-value: 0.023990% CI: [0.032, 0.293]Cochran-Mantel-Haenszel
Comparison: PF-00547659 225 mg vs placebo, centrally readp-value: 0.005290% CI: [0.08, 0.347]Cochran-Mantel-Haenszel
Comparison: PF-00547659 7.5 mg vs placebo, locally readp-value: 0.261790% CI: [-0.075, 0.186]Cochran-Mantel-Haenszel
Comparison: PF-00547659 22.5 mg vs placebo, locally readp-value: 0.005890% CI: [0.077, 0.347]Cochran-Mantel-Haenszel
Comparison: PF-00547659 75 mg vs placebo, locally readp-value: 0.032690% CI: [0.022, 0.29]Cochran-Mantel-Haenszel
Comparison: PF-00547659 225 mg vs placebo, locally readp-value: 0.014590% CI: [0.05, 0.32]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Mucosal Healing at Week 12
Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time frame: Week 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Mucosal Healing at Week 12 | Centrally read | 8.2 percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Week 12 | Locally read | 21.9 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Mucosal Healing at Week 12 | Centrally read | 15.5 percentage of participants |
| PF-00547659 7.5 mg | Percentage of Participants With Mucosal Healing at Week 12 | Locally read | 22.5 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Mucosal Healing at Week 12 | Centrally read | 27.8 percentage of participants |
| PF-00547659 22.5 mg | Percentage of Participants With Mucosal Healing at Week 12 | Locally read | 37.5 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Mucosal Healing at Week 12 | Locally read | 35.2 percentage of participants |
| PF-00547659 75 mg | Percentage of Participants With Mucosal Healing at Week 12 | Centrally read | 25.4 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Mucosal Healing at Week 12 | Centrally read | 14.3 percentage of participants |
| PF-00547659 225 mg | Percentage of Participants With Mucosal Healing at Week 12 | Locally read | 28.6 percentage of participants |
Comparison: PF-00547659 7.5 mg vs placebo, centrally readp-value: 0.061890% CI: [0, 0.162]Cochran-Mantel-Haenszel
Comparison: PF-00547659 22.5 mg vs placebo, centrally readp-value: 0.000990% CI: [0.091, 0.284]Cochran-Mantel-Haenszel
Comparison: PF-00547659 75 mg vs placebo, centrally readp-value: 0.002790% CI: [0.068, 0.25]Cochran-Mantel-Haenszel
Comparison: PF-00547659 225 mg vs placebo, centrally readp-value: 0.099990% CI: [-0.013, 0.151]Cochran-Mantel-Haenszel
Comparison: PF-00547659 7.5 mg vs placebo, locally readp-value: 0.522590% CI: [-0.111, 0.114]Cochran-Mantel-Haenszel
Comparison: PF-00547659 22.5 mg vs placebo, locally readp-value: 0.024690% CI: [0.03, 0.278]Cochran-Mantel-Haenszel
Comparison: PF-00547659 75 mg vs placebo, locally readp-value: 0.046490% CI: [0.008, 0.253]Cochran-Mantel-Haenszel
Comparison: PF-00547659 225 mg vs placebo, locally readp-value: 0.290% CI: [-0.053, 0.186]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12
Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.
Time frame: Baseline, Weeks 4, 8, and 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 4 (n=62,57,68,67,60) | -25.62 percent change |
| Placebo | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 12 (n=61,55,64,64,59) | -22.59 percent change |
| Placebo | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 8 (n=67,57,67,63,65) | -21.68 percent change |
| PF-00547659 7.5 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 8 (n=67,57,67,63,65) | -44.49 percent change |
| PF-00547659 7.5 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 4 (n=62,57,68,67,60) | -40.21 percent change |
| PF-00547659 7.5 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 12 (n=61,55,64,64,59) | -56.34 percent change |
| PF-00547659 22.5 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 8 (n=67,57,67,63,65) | -44.77 percent change |
| PF-00547659 22.5 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 4 (n=62,57,68,67,60) | -23.50 percent change |
| PF-00547659 22.5 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 12 (n=61,55,64,64,59) | -58.41 percent change |
| PF-00547659 75 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 4 (n=62,57,68,67,60) | -46.22 percent change |
| PF-00547659 75 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 12 (n=61,55,64,64,59) | -56.72 percent change |
| PF-00547659 75 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 8 (n=67,57,67,63,65) | -57.20 percent change |
| PF-00547659 225 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 8 (n=67,57,67,63,65) | -49.54 percent change |
| PF-00547659 225 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 4 (n=62,57,68,67,60) | -39.27 percent change |
| PF-00547659 225 mg | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Week 12 (n=61,55,64,64,59) | -64.52 percent change |
Comparison: PF-00547659 7.5 mg vs placebo, Week 4p-value: 0.974490% CI: [-101, 97.14]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Week 4p-value: 0.202390% CI: [-21.77, 171.66]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Week 4p-value: 0.580890% CI: [-65.09, 130.79]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Week 4p-value: 0.538890% CI: [-63.12, 138.34]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Week 8p-value: 0.890290% CI: [-106.24, 89.81]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Week 8p-value: 0.861690% CI: [-86.14, 106.54]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Week 8p-value: 0.568490% CI: [-133.49, 64.79]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Week 8p-value: 0.5790% CI: [-64.2, 131.86]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Week 12p-value: 0.623490% CI: [-130.56, 70.57]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Week 12p-value: 0.547490% CI: [-62.44, 134.38]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo,Week 12p-value: 0.191890% CI: [-20.48, 177.56]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Week 12p-value: 0.961590% CI: [-104.88, 98.91]Mixed Models Analysis
Secondary
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12
hsCRP was one of the PD biomarkers of the study.
Time frame: Baseline; Weeks 4, 8, and 12
Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 4 (n=67,64,69,71,65) | -11.60 percent change |
| Placebo | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 12 (n=67,62,68,71,64) | 14.85 percent change |
| Placebo | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 8 (n=71,63,69,71,68) | -2.42 percent change |
| PF-00547659 7.5 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 8 (n=71,63,69,71,68) | -6.00 percent change |
| PF-00547659 7.5 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 4 (n=67,64,69,71,65) | -19.17 percent change |
| PF-00547659 7.5 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 12 (n=67,62,68,71,64) | 4.51 percent change |
| PF-00547659 22.5 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 8 (n=71,63,69,71,68) | -31.43 percent change |
| PF-00547659 22.5 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 4 (n=67,64,69,71,65) | -26.90 percent change |
| PF-00547659 22.5 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 12 (n=67,62,68,71,64) | -20.40 percent change |
| PF-00547659 75 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 4 (n=67,64,69,71,65) | -35.21 percent change |
| PF-00547659 75 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 12 (n=67,62,68,71,64) | -15.96 percent change |
| PF-00547659 75 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 8 (n=71,63,69,71,68) | -43.15 percent change |
| PF-00547659 225 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 8 (n=71,63,69,71,68) | -22.70 percent change |
| PF-00547659 225 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 4 (n=67,64,69,71,65) | -17.70 percent change |
| PF-00547659 225 mg | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Week 12 (n=67,62,68,71,64) | 2.31 percent change |
Comparison: PF-00547659 7.5 mg vs placebo, Week 4p-value: 0.932890% CI: [-118.6, 131.41]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Week 4p-value: 0.896290% CI: [-132.91, 113.39]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Week 4p-value: 0.877590% CI: [-110.83, 133.74]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Week 4p-value: 0.822490% CI: [-142.02, 107.94]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Week 8p-value: 0.483190% CI: [-176.48, 71.02]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Week 8p-value: 0.118390% CI: [-236.63, 6.13]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo, Week 8p-value: 0.113990% CI: [-236.29, 4.69]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Week 8p-value: 0.193190% CI: [-218.17, 25.46]Mixed Models Analysis
Comparison: PF-00547659 7.5 mg vs placebo, Week 12p-value: 0.118290% CI: [-245.66, 6.32]Mixed Models Analysis
Comparison: PF-00547659 22.5 mg vs placebo, Week 12p-value: 0.578490% CI: [-165.34, 81.87]Mixed Models Analysis
Comparison: PF-00547659 75 mg vs placebo,Week 12p-value: 0.027990% CI: [-285.84, -41.29]Mixed Models Analysis
Comparison: PF-00547659 225 mg vs placebo, Week 12p-value: 0.105390% CI: [-249, 1.93]Mixed Models Analysis