Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Drug: PF-00547659 SC injection
- Registration Number
- NCT01276509
- Lead Sponsor
- Shire
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
- Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
- hsCRP greater than 3mg/L
- Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening
- Pregnant or breast feeding
- Short bowel syndrome due to multiple small bowel resections
- Presence of a stoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo-SC Injection PF-00547659 SC injection Placebo delivered SC, 3 doses separated by 4 weeks. Drug Dose level 2-SC injection PF-00547659 SC injection Drug dose level 2 delievered SC, 3 doses separated by 4 weeks. Drug Dose level 1- SC injection PF-00547659 SC injection Drug dose level 1 delivered SC, 3 doses separated by 4 weeks. Drug Dose level 3- SC injection PF-00547659 SC injection Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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).
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.
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.
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.
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.
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
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)
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.
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.
Trial Locations
- Locations (137)
Nassau Gastroenterology Associates Office Based Surgery
🇺🇸Great Neck, New York, United States
Nassau Gastroenterology Associates, P.C.
🇺🇸Great Neck, New York, United States
North Shore Primary Care, P.C.
🇺🇸Great Neck, New York, United States
Wits Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Miami
🇺🇸Miami, Florida, United States
UCSD Medical Center-Thornton Hospital
🇺🇸La Jolla, California, United States
Clopton Clinic
🇺🇸Jonesboro, Arkansas, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Florida Center for Gastroenterology
🇺🇸Largo, Florida, United States
Heartland Medical Research (Administrative Only)
🇺🇸Clive, Iowa, United States
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Gastroenterology Specialists of Arkansas
🇺🇸Jonesboro, Arkansas, United States
Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique
🇧🇪Liege, Belgium
Centre Hospitalier de Mouscron
🇧🇪Mouscron, Belgium
Connecticut Clinical Research Foundation
🇺🇸Bristol, Connecticut, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Surgery Center of Columbia
🇺🇸Columbia, Missouri, United States
Life Medi-Research And Management
🇺🇸Brooklyn, New York, United States
Little Rock Diagnostic Clinic, P.A.
🇺🇸Little Rock, Arkansas, United States
Gastro Diagnostics
🇺🇸Orange, California, United States
Barnes-Jewish Hospital - Investigational Drug Services
🇺🇸Saint Louis, Missouri, United States
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
University of Massachusetts Worcester
🇺🇸Worcester, Massachusetts, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Rocky Mountain Gastroenterology Associates
🇺🇸Thornton, Colorado, United States
Surgical Centers of Michigan
🇺🇸Troy, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Minnesota Gastroenterology, P.A.
🇺🇸Plymouth, Minnesota, United States
MBAL Sofiamed OOD,Otdelenie po gastroenterologia
🇧🇬Sofia, Bulgaria
Center for Advanced Medicine
🇺🇸Saint Louis, Missouri, United States
New York Hospital Queens
🇺🇸Flushing, New York, United States
University Medical Center Groningen (UMCG)
🇳🇱Groningen, GR, Netherlands
Consulting Radiology (Xray testing only)
🇺🇸Plymouth, Minnesota, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Offices of Dr. Vincent Armenio, M.D.
🇺🇸East Providence, Rhode Island, United States
Hopital Beaujon- Essais cliniques
🇫🇷Clichy Cedex, France
Universitaetsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
GI Associates
🇺🇸Wauwatosa, Wisconsin, United States
Oslo Universitetssykehus
🇳🇴Oslo, Norway
AKH Wien Universitaetsklinik fuer Innere Medizin III
🇦🇹Wien, Austria
Bayside Endoscopy Center
🇺🇸Providence, Rhode Island, United States
Charlottesville Gastroenterology Associates
🇺🇸Charlottesville, Virginia, United States
Oshawa Clinic
🇨🇦Oshawa, Ontario, Canada
Hillsborough Campus
🇺🇸Hillsborough, North Carolina, United States
Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center
🇺🇸Pasadena, Texas, United States
Pharma Resource
🇺🇸East Providence, Rhode Island, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Allegiance Research Specialists
🇺🇸Wauwatosa, Wisconsin, United States
Hopital Charles Nicolle
🇫🇷Rouen Cedex 1, France
Hopital Rangueil
🇫🇷Toulouse cedex 09, France
Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.
🇵🇱Lodz, Poland
CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie
🇫🇷Amiens Cedex 01, France
Charite - Campus Berlin Mitte Medizinische Klinik
🇩🇪Berlin, Germany
4-MHAT
🇧🇬Sofia, Bulgaria
Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie
🇩🇪Luebeck, Germany
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
National Hospital Organization Hirosaki National Hospital
🇯🇵Hirosaki, Aomori, Japan
Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
Universitaetsklinikum Regensburg
🇩🇪Regensburg, Germany
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Chiba University Hospital
🇯🇵Chiba, Japan
Hopital de l'Archet 2 - CHU de Nice
🇫🇷NICE Cedex 3, France
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Military Medical Academy
🇷🇸Belgrade, Serbia
Clinical Hospital Centre Bezanijska Kosa
🇷🇸Belgrade, Serbia
Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
🇸🇰Bratislava, Slovakia
Hospital Universitari Bellvitge
🇪🇸Barcelona, Spain
Minneapolis Heart Institute, West Health Campus
🇺🇸Minneapolis, Minnesota, United States
Noran Neurology Clinic
🇺🇸Minneapolis, Minnesota, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
University of Utah HSC
🇺🇸Salt Lake City, Utah, United States
Hopital Nord
🇫🇷St Priest En Jarez, France
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
East side Endoscopy, LLC (for colonscopy testing only)
🇺🇸New York, New York, United States
Lenox Hill Endoscopy Center
🇺🇸New York, New York, United States
University of Miami Hospital and Clinic
🇺🇸Miami, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Audrain Medical Center
🇺🇸Mexico, Missouri, United States
Center for Digestive and Liver Diseases, Inc.
🇺🇸Mexico, Missouri, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, New York, United States
Albany Medical College
🇺🇸Albany, New York, United States
Long Island Clinical Research Associates, LLP
🇺🇸Great Neck, New York, United States
Beth Israel Medical Center - Phillip Ambulatory Care Center
🇺🇸New York, New York, United States
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire de Liege
🇧🇪Liege, Belgium
Vancouver Coastal Health - Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Vancouver Coastal Health - Vancouver Hospital
🇨🇦Vancouver, British Columbia, Canada
Toronto Digestive Disease Associates Inc.
🇨🇦Vaughan, Ontario, Canada
Hopital Cochin-Essais Cliniques
🇫🇷Paris, France
Hopital Saint-Andre
🇫🇷Bordeaux cedex, France
Gastroenterologische Gemeinschaftspraxis Minden
🇩🇪Minden, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
🇩🇪Halle, Germany
Universitaetklinikum Ulm
🇩🇪Ulm, Germany
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
National Hospital Organization Takasaki General Medical Center
🇯🇵Takasaki, Gunma, Japan
Aichi Medical University Hospital
🇯🇵Aichi, Japan
Yokohama City University Medical Center
🇯🇵Kanagawa, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University College of Medicine, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Academic Medical Center
🇳🇱Amsterdam, NH, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Asker And Baerum Hospital
🇳🇴Gjettum, Norway
Lexmedica
🇵🇱Wroclaw, Poland
Lovisenberg Diakonale Sykehus
🇳🇴Oslo, Norway
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie
🇵🇱Warszawa, Poland
Clinical Hospital Center Zemun
🇷🇸Zemun, Serbia
Clinical Center Nis Clinic for Gastroenterology and Hepatology
🇷🇸Nis, Serbia
Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.
🇸🇰Nitra, Slovakia
Medak s.r.o.
🇸🇰Bratislava, Slovakia
Synergy group, a.s.
🇸🇰Nove Mesto Nad Vahom, Slovakia
Parklands Medical Centre
🇿🇦Durban, Kwa-zulu - Natal, South Africa
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Corporacio Sanitaria Parc Tauli de Sabadell
🇪🇸Sabadell, Spain
Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej
🇵🇱Bydgoszcz, Poland
Kingsbury Hospital
🇿🇦Cape Town, Western CAPE, South Africa
Cirtus Ambulartory Surgery Center
🇺🇸Orlando, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CTRC Hospital - UNC Memorial Hospital
🇺🇸Chapel Hill, North Carolina, United States
North Carolina Memorial Hospital Endoscopy Center
🇺🇸Chapel Hill, North Carolina, United States
UNC Hospitals Department of Pharmacy
🇺🇸Chapel Hill, North Carolina, United States
UNC Hospitals Endoscopy
🇺🇸Chapel Hill, North Carolina, United States
Shands Endoscopy Center
🇺🇸Gainesville, Florida, United States
Shands Hospital at the University of Florida
🇺🇸Gainesville, Florida, United States
Shands Medical Plaza
🇺🇸Gainesville, Florida, United States
Clinical Research of the Rockies
🇺🇸Lafayette, Colorado, United States
BioMark Research Inc.
🇺🇸Whittier, California, United States
Iowa Endoscopy Center (Colonoscopy Only)
🇺🇸Clive, Iowa, United States
Inland Gastroenterology Medical Associates, Inc.
🇺🇸Redlands, California, United States