Trial · NCT01276509
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax) | 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. | Hours | MEDIAN |
| SECONDARY | The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf) | 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. | Day | MEAN |
| SECONDARY | The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F) | 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. | mL/hr | GEOMETRIC_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.
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