Trial · NCT01298492
A Study To Monitor Long-Term Treatment With PF-00547659
NCT01298492, Phase 2, Completed, Shire; results first posted 2017-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study To Monitor Long-Term Treatment With PF-00547659. Trials, record NCT01298492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01298492
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Monitor Long-Term Treatment With PF-00547659
- NCT number
- NCT01298492
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 268 participants, actual
- Lead sponsor
- Shire
- Conditions
- Crohn's Disease
- Interventions
- PF-00547659
- First posted
- 2011-02-17
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2010-024638-48
- Results first posted
- 2017-08-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) | From start of study treatment up to Week 72 (Treatment Period) | AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect. |
| Secondary | Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies | Baseline up to Week 96 | Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (\>=) 4.64 at at least one of the time points. |
| Secondary | Serum Trough Concentrations of PF-00547659 Versus Time | Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96 | Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) | From start of study treatment up to Week 72 (Treatment Period) | The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies | Baseline up to Week 96 | The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Trough Concentrations of PF-00547659 Versus Time | Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96 | PK population included all enrolled participants who received at least 1 dose of investigational product and had data on at least 1 PK concentration. | nanogram per milliliter (ng/mL) | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) | PF-00547659 75 mg | Participants With AEs | 249 | Participants | |
| Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) | PF-00547659 75 mg | Participants With AEs Led to Withdrawal | 53 | Participants | |
| Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) | PF-00547659 75 mg | Participants With SAEs | 80 | Participants | |
| Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies | PF-00547659 75 mg | 63 | Participants | ||
| Serum Trough Concentrations of PF-00547659 Versus Time | PF-00547659 75 mg | Week 4 | 6673 | Standard Deviation 6634.2 | nanogram per milliliter (ng/mL) |
| Serum Trough Concentrations of PF-00547659 Versus Time | PF-00547659 75 mg | Week 8 | 6064 | Standard Deviation 4455.3 | nanogram per milliliter (ng/mL) |
| Serum Trough Concentrations of PF-00547659 Versus Time | PF-00547659 75 mg | Week 12 | 8040 | Standard Deviation 6293.1 | nanogram per milliliter (ng/mL) |
| Serum Trough Concentrations of PF-00547659 Versus Time | PF-00547659 75 mg | Week 16 | 9563 | Standard Deviation 7285.4 | nanogram per milliliter (ng/mL) |
| Serum Trough Concentrations of PF-00547659 Versus Time | PF-00547659 75 mg | Week 20 | 10400 | Standard Deviation 8438.6 | nanogram per milliliter (ng/mL) |
| Serum Trough Concentrations of PF-00547659 Versus Time | PF-00547659 75 mg | Week 24 | 10450 | Standard Deviation 7934.6 | nanogram per milliliter (ng/mL) |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-00547659 75 mg | 268 | |
| Overall Study | COMPLETED | PF-00547659 75 mg | 149 | |
| Overall Study | NOT COMPLETED | PF-00547659 75 mg | 119 |
Source ClinicalTrials.gov
Adverse events108
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 | Arthralgia | Musculoskeletal and connective tissue disorders | PF-00547659 75 mg | 83 | 268 | 113 |
| other | Back pain | Musculoskeletal and connective tissue disorders | PF-00547659 75 mg | 28 | 268 | 30 |
| other | Abdominal pain | Gastrointestinal disorders | PF-00547659 75 mg | 49 | 268 | 59 |
| other | Anal fissure | Gastrointestinal disorders | PF-00547659 75 mg | 14 | 268 | 14 |
| other | Aphthous ulcer | Gastrointestinal disorders | PF-00547659 75 mg | 14 | 268 | 18 |
| other | Crohn's disease | Gastrointestinal disorders | PF-00547659 75 mg | 79 | 268 | 111 |
| other | Diarrhoea | Gastrointestinal disorders | PF-00547659 75 mg | 24 | 268 | 38 |
| other | Nausea | Gastrointestinal disorders | PF-00547659 75 mg | 32 | 268 | 44 |
| other | Vomiting | Gastrointestinal disorders | PF-00547659 75 mg | 23 | 268 | 34 |
| other | Asthenia | General disorders | PF-00547659 75 mg | 15 | 268 | 20 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-00547659 75 mg | 2 | 268 |
| Total, other adverse events | PF-00547659 75 mg | 206 | 268 |
| Total, serious adverse events | PF-00547659 75 mg | 118 | 268 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34427633 | DERIVED |
Source PubMed
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.
GET https://conductscience.org/api/trials/v1/NCT01298492
GET https://conductscience.org/api/trials/v1/NCT01298492/results?page=2