Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
Placebo delivered SC, 3 doses separated by 4 weeks
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate
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.
Time frame: Week 8 and week 12
Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo
Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.
Time frame: Week 0-12
Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo
Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.
Time frame: Week 0-12
Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission
Percentage of participants with a CDAI remission (defined as a CDAI reduction to \<150 points).
Time frame: Weeks 8 and week 12
Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time
Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.
Time frame: Week 2, 4, 6, 8, 10 and 12
Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer
Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.
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Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Clopton Clinic
Jonesboro, Arkansas, United States
Gastroenterology Specialists of Arkansas
Jonesboro, Arkansas, United States
Little Rock Diagnostic Clinic, P.A.
Little Rock, Arkansas, United States
UCSD Medical Center-Thornton Hospital
La Jolla, California, United States
Community Clinical Trials
Orange, California, United States
Gastro Diagnostics
Orange, California, United States
Inland Gastroenterology Medical Associates, Inc.
Redlands, California, United States
BioMark Research Inc.
Whittier, California, United States
Clinical Research of the Rockies
Lafayette, Colorado, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States
...and 127 more locations
Time frame: Week 2, 4, 6, 8, 10 and 12
Immunogenicity Assessment of Anti-drug Antibodies (ADAs)
Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659
Time frame: Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
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.
Time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)
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)
Time frame: Day 1, 14, and 28
The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)
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.
Time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)
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.
Time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)
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.
Time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)
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.
Time frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252