Trial · NCT01620255
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 | Baseline (BL), 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 for that specific domain. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) | Screening through to end of treatment period, up to 12 weeks | All randomized participants who received at least 1 dose of study treatment. | participants | NUMBER |
| SECONDARY | Maximum Serum PF-00547659 Concentration Achieved | Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal | Participants who received active treatment (PF-00547659) were included in this analysis. | nanograms (ng)/milliliter (mL) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT01620255/outcomes