Trial · NCT01620255
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
NCT01620255, Phase 2, Completed, Shire; results first posted 2017-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis. Trials, record NCT01620255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01620255
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
- NCT number
- NCT01620255
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 357 participants, actual
- Lead sponsor
- Shire
- Conditions
- Ulcerative Colitis
- Interventions
- Placebo, PF-00547659 SC Injection, PF-00547659 SC Injection, PF-00547659 SC Injection, PF-00547659 SC Injection
- First posted
- 2012-06-15
- Last updated
- 2021-06-11
- Other registries' IDs
- eudract:2012-002030-37
- Results first posted
- 2017-03-27
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| 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 | 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". |
| Secondary | 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. |
| 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Clinical Remission at Week 12 | Week 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Week 12 | Week 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Mucosal Healing at Week 12 | Week 12 | 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. | percentage of participants | NUMBER |
| 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 | Weeks 4, 8, and 12 | As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented. | ||
| SECONDARY | Change From Baseline in Total Mayo Score at Week 12 | Baseline, Week 12 | 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. | units on a scale | MEAN |
| 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 | Baseline; Weeks (W) 4, 8, and 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 | Baseline, Week 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 | Baseline, Weeks 4, 8, and 12 | 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. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 | Baseline; Weeks 4, 8, and 12 | 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. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 | Baseline, Week 12 | 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. | units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group304
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Clinical Remission at Week 12 | Placebo | Centrally read | 2.7 | 90% Confidence Interval 0.7 to 7.6 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 7.5 mg | Centrally read | 11.3 | 90% Confidence Interval 5.7 to 18.8 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 22.5 mg | Centrally read | 16.7 | 90% Confidence Interval 9.9 to 25.4 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 75 mg | Centrally read | 15.5 | 90% Confidence Interval 9.5 to 23.6 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 225 mg | Centrally read | 5.7 | 90% Confidence Interval 2.5 to 12.5 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | Placebo | Locally read | 5.5 | 90% Confidence Interval 2.4 to 12.0 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 7.5 mg | Locally read | 14.1 | 90% Confidence Interval 7.8 to 22.0 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 22.5 mg | Locally read | 23.6 | 90% Confidence Interval 15.6 to 33.1 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 75 mg | Locally read | 18.3 | 90% Confidence Interval 11.9 to 27.1 | percentage of participants |
| Percentage of Participants in Clinical Remission at Week 12 | PF-00547659 225 mg | Locally read | 12.9 | 90% Confidence Interval 7.3 to 21.1 | percentage of participants |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 73 | |
| Overall Study | STARTED | PF-00547659 7.5 mg | 71 | |
| Overall Study | STARTED | PF-00547659 22.5 mg | 70 | |
| Overall Study | STARTED | PF-00547659 75 mg | 73 | |
| Overall Study | STARTED | PF-00547659 225 mg | 70 | |
| Overall Study | Treated | Placebo | 73 | |
| Overall Study | Treated | PF-00547659 7.5 mg | 71 | |
| Overall Study | Treated | PF-00547659 22.5 mg | 70 | |
| Overall Study | Treated | PF-00547659 75 mg | 73 | |
| Overall Study | Treated | PF-00547659 225 mg | 70 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events145
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00547659 7.5 mg | 0 | 71 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00547659 22.5 mg | 2 | 70 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00547659 75 mg | 4 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00547659 225 mg | 2 | 70 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 73 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-00547659 7.5 mg | 6 | 71 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-00547659 22.5 mg | 3 | 70 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-00547659 75 mg | 2 | 73 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-00547659 225 mg | 1 | 70 |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PF-00547659 7.5 mg | ||
| Total, all-cause mortality | PF-00547659 22.5 mg | ||
| Total, all-cause mortality | PF-00547659 75 mg | ||
| Total, all-cause mortality | PF-00547659 225 mg | ||
| Total, other adverse events | Placebo | 17 | 73 |
| Total, other adverse events | PF-00547659 7.5 mg | 16 | 71 |
| Total, other adverse events | PF-00547659 22.5 mg | 15 | 70 |
| Total, other adverse events | PF-00547659 75 mg | 14 | 73 |
| Total, other adverse events | PF-00547659 225 mg | 18 | 70 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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