Trial · NCT01387594
Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs
NCT01387594, Phase 1, Completed, Shire; results first posted 2017-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs. Trials, record NCT01387594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01387594
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs
- NCT number
- NCT01387594
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 49 participants, actual
- Lead sponsor
- Shire
- Conditions
- Crohn's Disease, Ileitis, Ileo-colonic and Colonic Crohn's Disease, Granulomatous Colitis, Regional Enteritis, Ulcerative Colitis
- Interventions
- lumbar puncture, lumbar puncture
- First posted
- 2011-07-04
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2011-001443-74
- Results first posted
- 2017-04-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) | Baseline | The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle. |
| Primary | Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3 | Baseline, Month 3 | The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle. |
| Secondary | Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Baseline up to Week 12 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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/birth defect. Treatment-emergent for this measure are events between first dose of study drug and up to 85 days (Week 12) after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and non-serious AEs. |
| Secondary | Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 | Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal | Serum samples were analysed for presence of ADAs to PF-00547659. Participants who showed positive results for PF-00547659 were reported. |
| Secondary | Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity | Baseline till End of Study/Early Withdrawal, up to Week 12 | Injection site reaction AEs include: injection site irritation, injection site pain, injection site rash, contusion, and erythema. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) | Baseline | All Cohort 2 participants who were enrolled, had 2 evaluable LPs, and who received all 3 doses of study drug. | cells per milliliter (cells/mL) | MEDIAN |
| PRIMARY | Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3 | Baseline, Month 3 | All Cohort 2 participants who were enrolled, had 2 evaluable lumbar punctures, and who received all 3 doses of study drug. | percent change | MEDIAN |
| SECONDARY | Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Baseline up to Week 12 | All participants who received at least one dose of study drug were analyzed for AEs/safety. Combined data for both cohorts is presented. | participants | NUMBER |
| SECONDARY | Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 | Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal | All participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity | Baseline till End of Study/Early Withdrawal, up to Week 12 | All participants who received at least one dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) | Cohort 2: PF-00547659 | 338.5 | Full Range 689.69 | cells per milliliter (cells/mL) | |
| Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3 | Cohort 2: PF-00547659 | 35.2 | Full Range 92.67 | percent change | |
Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Cohort 1: PF-00547659 | AEs | 9 | participants | |
Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Cohort 2: PF-00547659 | AEs | 36 | participants | |
Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Cohort 1: PF-00547659 | Withdrawals due to AEs | 0 | participants | |
Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Cohort 2: PF-00547659 | Withdrawals due to AEs | 0 | participants | |
Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Cohort 1: PF-00547659 | SAEs | 1 | participants | |
Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | Cohort 2: PF-00547659 | SAEs | 3 | participants | |
| Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 | Cohort 1: PF-00547659 | 4 | participants | ||
| Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 | Cohort 2: PF-00547659 | 11 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: PF-00547659 | 10 | |
| Overall Study | STARTED | Cohort 2: PF-00547659 | 39 | |
| Overall Study | COMPLETED | Cohort 1: PF-00547659 | 10 | |
| Overall Study | COMPLETED | Cohort 2: PF-00547659 | 36 | |
| Overall Study | NOT COMPLETED | Cohort 1: PF-00547659 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2: PF-00547659 | 3 |
Source ClinicalTrials.gov
Adverse events224
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 | Cohort 1: PF-00547659 | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: PF-00547659 | 1 | 39 | |
| other | Tachycardia | Cardiac disorders | Cohort 1: PF-00547659 | 1 | 10 | |
| other | Tachycardia | Cardiac disorders | Cohort 2: PF-00547659 | 0 | 39 | |
| other | Eye inflammation | Eye disorders | Cohort 1: PF-00547659 | 0 | 10 | |
| other | Eye inflammation | Eye disorders | Cohort 2: PF-00547659 | 2 | 39 | |
| other | Eye pain | Eye disorders | Cohort 1: PF-00547659 | 0 | 10 | |
| other | Eye pain | Eye disorders | Cohort 2: PF-00547659 | 1 | 39 | |
| other | Eyelid oedema | Eye disorders | Cohort 1: PF-00547659 | 0 | 10 | |
| other | Eyelid oedema | Eye disorders | Cohort 2: PF-00547659 | 1 | 39 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: PF-00547659 | ||
| Total, all-cause mortality | Cohort 2: PF-00547659 | ||
| Total, other adverse events | Cohort 1: PF-00547659 | 9 | 10 |
| Total, other adverse events | Cohort 2: PF-00547659 | 37 | 39 |
| Total, serious adverse events | Cohort 1: PF-00547659 | 1 | 10 |
| Total, serious adverse events | Cohort 2: PF-00547659 | 3 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28778448 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: PF-00547659 vs Cohort 2: PF-00547659: Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 | Trial comparisons |
| Cohort 1: PF-00547659 vs Cohort 2: PF-00547659: serious adverse events | Trial comparisons |
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/NCT01387594
GET https://conductscience.org/api/trials/v1/NCT01387594/events?page=2