Trial · NCT01276509
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate | Week 8 and week 12 | Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group. |
| Secondary | Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo | Week 0-12 | Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported. |
| Secondary | Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo | Week 0-12 | Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group. |
| Secondary | Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission | Weeks 8 and week 12 | Percentage of participants with a CDAI remission (defined as a CDAI reduction to \<150 points). |
| Secondary | Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time | Week 2, 4, 6, 8, 10 and 12 | Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported. |
| Secondary | Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer | Week 2, 4, 6, 8, 10 and 12 | Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported. |
| Secondary | Immunogenicity Assessment of Anti-drug Antibodies (ADAs) | Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36 | Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659 |
| 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 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time. |
| 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 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks) |
| 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 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration. |
| 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 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax. |
| 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 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life. |
| 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 | The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance. |
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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