Trial · NCT01771809
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
NCT01771809, Phase 2, Completed, Shire; results first posted 2019-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Safety Of PF-00547659 In Ulcerative Colitis. Trials, record NCT01771809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01771809
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety Of PF-00547659 In Ulcerative Colitis
- NCT number
- NCT01771809
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 330 participants, actual
- Lead sponsor
- Shire
- Conditions
- Ulcerative Colitis
- Interventions
- 75mg SHP647 (PF-00547659), 225mg SHP647 (PF-00547659)
- First posted
- 2013-01-18
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2012-002031-28
- Results first posted
- 2019-04-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to 168 weeks | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported. |
| Secondary | Percentage of Participants With Mucosal Healing at Week 16 | Week 16 | Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment \[PGA\]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported. |
| Secondary | Serum Trough Concentrations of SHP647 Versus Time | Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156 | Serum trough concentrations of SHP647 versus time was reported. |
| Secondary | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Baseline, Week 8, 16, 24, 40, 48, 64 and 156 | The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. The number of participants with positive ADA was reported. |
| Secondary | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline, Week 8, 16, 24, 40, 48, 64 and 156 | The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (\>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. |
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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to 168 weeks | SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Mucosal Healing at Week 16 | Week 16 | SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. | Percentage of participants | NUMBER |
| SECONDARY | Serum Trough Concentrations of SHP647 Versus Time | Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156 | The pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of SHP647 and for whom at least 1 postdose PK sample was collected. Here 'Number of Participants Analyzed' refers to the number of participants evaluable for specific timepoint. | Micrograms/liter (ug/L) | MEAN |
| SECONDARY | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Baseline, Week 8, 16, 24, 40, 48, 64 and 156 | The SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specific time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline, Week 8, 16, 24, 40, 48, 64 and 156 | Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specific time points with non-missing ADA sample. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group116
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 Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | SHP647 75 mg | Participants with any TEAE | 146 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | SHP647 225 mg | Participants with any TEAE | 147 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | SHP647 75 mg | Participants with any TESAE | 34 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | SHP647 225 mg | Participants with any TESAE | 40 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | SHP647 75 mg | Participants who withdrew treatment due to TEAE | 12 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | SHP647 225 mg | Participants who withdrew treatment due to TEAE | 23 | Participants | |
| Percentage of Participants With Mucosal Healing at Week 16 | SHP647 75 mg | 27.4 | Percentage of participants | ||
| Percentage of Participants With Mucosal Healing at Week 16 | SHP647 225 mg | 29.5 | Percentage of participants | ||
| Serum Trough Concentrations of SHP647 Versus Time | SHP647 75 mg | Baseline | 6398.62 | Standard Deviation 8584.412 | Micrograms/liter (ug/L) |
| Serum Trough Concentrations of SHP647 Versus Time | SHP647 225 mg | Baseline | 8064.41 | Standard Deviation 10629.768 | Micrograms/liter (ug/L) |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHP647 75 mg | 164 | |
| Overall Study | STARTED | SHP647 225 mg | 166 | |
| Overall Study | COMPLETED | SHP647 75 mg | 93 | |
| Overall Study | COMPLETED | SHP647 225 mg | 83 | |
| Overall Study | NOT COMPLETED | SHP647 75 mg | 71 | |
| Overall Study | NOT COMPLETED | SHP647 225 mg | 83 |
Source ClinicalTrials.gov
Adverse events176
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 | SHP647 75 mg | 27 | 164 | 41 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | SHP647 225 mg | 29 | 166 | 42 |
| other | Back pain | Musculoskeletal and connective tissue disorders | SHP647 75 mg | 12 | 164 | 15 |
| other | Back pain | Musculoskeletal and connective tissue disorders | SHP647 225 mg | 18 | 166 | 20 |
| other | Abdominal pain | Gastrointestinal disorders | SHP647 75 mg | 9 | 164 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | SHP647 225 mg | 20 | 166 | 33 |
| other | Colitis ulcerative | Gastrointestinal disorders | SHP647 75 mg | 41 | 164 | 52 |
| other | Colitis ulcerative | Gastrointestinal disorders | SHP647 225 mg | 36 | 166 | 50 |
| other | Diarrhoea | Gastrointestinal disorders | SHP647 75 mg | 11 | 164 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | SHP647 225 mg | 7 | 166 | 11 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHP647 75 mg | 1 | 164 |
| Total, all-cause mortality | SHP647 225 mg | 0 | 166 |
| Total, other adverse events | SHP647 75 mg | 116 | 164 |
| Total, other adverse events | SHP647 225 mg | 119 | 166 |
| Total, serious adverse events | SHP647 75 mg | 34 | 164 |
| Total, serious adverse events | SHP647 225 mg | 40 | 166 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| SHP647 75 mg vs SHP647 225 mg: deaths from any cause | Trial comparisons |
| SHP647 75 mg vs SHP647 225 mg: 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/NCT01771809
GET https://conductscience.org/api/trials/v1/NCT01771809/results?page=2