Trial · NCT01276509
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
NCT01276509, Phase 2, Completed, Shire; results first posted 2017-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease. Trials, record NCT01276509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01276509
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
- NCT number
- NCT01276509
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 265 participants, actual
- Lead sponsor
- Shire
- Conditions
- Crohn's Disease
- Interventions
- PF-00547659 SC injection, PF-00547659 SC injection, PF-00547659 SC injection, PF-00547659 SC injection
- First posted
- 2011-01-13
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2010-023437-30
- Results first posted
- 2017-04-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | Week 8 and week 12 | Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group. |
| Secondary | Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo | Week 0-12 | Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported. |
| Secondary | Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo | Week 0-12 | Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group. |
| Secondary | Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission | Weeks 8 and week 12 | Percentage of participants with a CDAI remission (defined as a CDAI reduction to \<150 points). |
| Secondary | Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time | Week 2, 4, 6, 8, 10 and 12 | Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported. |
| Secondary | Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer | Week 2, 4, 6, 8, 10 and 12 | Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported. |
| Secondary | Immunogenicity Assessment of Anti-drug Antibodies (ADAs) | Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36 | Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659 |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time. |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau) | Day 1, 14, and 28 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks) |
| Secondary | The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax) | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | Week 8 and week 12 | The full analysis set included all randomized participants who received at least one dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo | Week 0-12 | The safety analysis set included all participants who received at least 1 dose of study medication. | Number of participants | NUMBER |
| SECONDARY | Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo | Week 0-12 | The safety analysis set included all participants who received at least 1 dose of study medication. | events | NUMBER |
| SECONDARY | Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission | Weeks 8 and week 12 | The full analysis set included all randomized participants who received at least one dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time | Week 2, 4, 6, 8, 10 and 12 | The full analysis set included all randomized participants who received at least one dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer | Week 2, 4, 6, 8, 10 and 12 | The full analysis set included all randomized participants who received at least one dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Immunogenicity Assessment of Anti-drug Antibodies (ADAs) | Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36 | The safety analysis set included all participants who receive at least 1 dose of PF-00547659. Participants in placebo arm were not included in this analysis. | events | NUMBER |
| SECONDARY | The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis. | µg•hr/mL | GEOMETRIC_MEAN |
| SECONDARY | The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau) | Day 1, 14, and 28 | All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis. | µg•hr/mL | GEOMETRIC_MEAN |
| SECONDARY | The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax) | Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 | All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis. | µg/mL | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | PF-00547659 22.5 mg | Week 8 (n =50, 55, 62, 56) | 52.7 | Percentage of Participants | |
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | PF-00547659 75 mg | Week 8 (n =50, 55, 62, 56) | 60.1 | Percentage of Participants | |
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | PF-00547659 225 mg | Week 8 (n =50, 55, 62, 56) | 62.7 | Percentage of Participants | |
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | Placebo | Week 8 (n =50, 55, 62, 56) | 47.7 | Percentage of Participants | |
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | PF-00547659 22.5 mg | Week 12 (n = 51, 49, 61, 54) | 62.0 | Percentage of Participants | |
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | PF-00547659 75 mg | Week 12 (n = 51, 49, 61, 54) | 64.7 | Percentage of Participants | |
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | PF-00547659 225 mg | Week 12 (n = 51, 49, 61, 54) | 57.5 | Percentage of Participants | |
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | Placebo | Week 12 (n = 51, 49, 61, 54) | 58.6 | Percentage of Participants | |
| Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo | PF-00547659 22.5 mg | Participants with AEs (all causalities) | 57 | Number of participants | |
| Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo | PF-00547659 75 mg | Participants with AEs (all causalities) | 51 | Number of participants |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-00547659 22.5 mg | 66 | |
| Overall Study | STARTED | PF-00547659 75 mg | 65 | |
| Overall Study | STARTED | PF-00547659 225 mg | 68 | |
| Overall Study | STARTED | Placebo | 63 | |
| Overall Study | COMPLETED | PF-00547659 22.5 mg | 53 | |
| Overall Study | COMPLETED | PF-00547659 75 mg | 53 | |
| Overall Study | COMPLETED | PF-00547659 225 mg | 63 | |
| Overall Study | COMPLETED | Placebo | 58 | |
| Overall Study | NOT COMPLETED | PF-00547659 22.5 mg | 13 | |
| Overall Study | NOT COMPLETED | PF-00547659 75 mg | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events192
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 | Abdominal pain | Gastrointestinal disorders | PF-00547659 22.5 mg | 7 | 66 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-00547659 75 mg | 1 | 65 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-00547659 225 mg | 4 | 68 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 63 | |
| other | Crohn's disease | Gastrointestinal disorders | PF-00547659 22.5 mg | 5 | 66 | |
| other | Crohn's disease | Gastrointestinal disorders | PF-00547659 75 mg | 7 | 65 | |
| other | Crohn's disease | Gastrointestinal disorders | PF-00547659 225 mg | 1 | 68 | |
| other | Crohn's disease | Gastrointestinal disorders | Placebo | 5 | 63 | |
| other | Diarrhoea | Gastrointestinal disorders | PF-00547659 22.5 mg | 1 | 66 | |
| other | Diarrhoea | Gastrointestinal disorders | PF-00547659 75 mg | 4 | 65 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| 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, all-cause mortality | Placebo | ||
| Total, other adverse events | PF-00547659 22.5 mg | 36 | 66 |
| Total, other adverse events | PF-00547659 75 mg | 32 | 65 |
| Total, other adverse events | PF-00547659 225 mg | 42 | 68 |
| Total, other adverse events | Placebo | 35 | 63 |
| Total, serious adverse events | PF-00547659 22.5 mg | 12 | 66 |
| Total, serious adverse events | PF-00547659 75 mg | 11 | 65 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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