B0151005 Open-Label Extension Study
- Conditions
- Crohn's Disease
- Interventions
- Biological: PF-04236921
- Registration Number
- NCT01345318
- Lead Sponsor
- Pfizer
- Brief Summary
This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.
- Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
- Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-label Treatment PF-04236921 -
- Primary Outcome Measures
Name Time Method Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76. Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (\>=) 4.32. Any positive ADA sample was further tested for NAbs.
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs Baseline up to Week 48 An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (127)
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Hospital Israelita Albert Einstein
🇧🇷São Paulo, SP, Brazil
Fakultni Nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Texas Digestive Disease Consultants
🇺🇸Southlake, Texas, United States
Digestive Health Specialists of Tyler
🇺🇸Tyler, Texas, United States
Aarhus Universitetshospital, Aarhus Sygehus
🇩🇰Aarhus C, Denmark
Laboratório de Análises ClÃnicas do HUCFF/UFRJ
🇧🇷Rio de Janeiro, RJ, Brazil
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Mater Health Services
🇦🇺South Brisbane, Queensland, Australia
Heritage Medical Research Clinic - University of Calgary
🇨🇦Calgary, Alberta, Canada
London Health Science Centre - University Hospital
🇨🇦London, Ontario, Canada
Hospital Universitário Fraga Filho da UFRJ
🇧🇷Rio de Janeiro, RJ, Brazil
Barts Health NHS Trust-Royal London Hospital
🇬🇧London, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
Hospital Nossa Senhora das Gracas
🇧🇷Curitiba, PR, Brazil
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
"Gastroenheden Herlev Hospital
🇩🇰Herlev, Denmark
Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas
🇧🇷Curitiba, PR, Brazil
Setor de Cardiologia do Hospital Nossa Senhora das Gracas
🇧🇷Curitiba, PR, Brazil
Hepato-Gastroenterologie HK, s.r.o. Poliklinika III
🇨🇿Hradec Kralove, Czechia
Gastroenterologische Gemeinschaftspraxis Minden
🇩🇪Minden, Germany
"Kirurgisk Afdeling 0143 Hilleroed Hospital
🇩🇰Hilleroed, Denmark
Universita Campus Biomedico UOC di Gastroenterologia
🇮🇹Roma, Italy
Institut klinicke a experimentalni mediciny
🇨🇿Praha 4, Czechia
Krajska zdravotni, a.s.
🇨🇿Usti nad Labem, Czechia
Hopital Huriez CHRU de Lille
🇫🇷Lille Cedex, France
Universitaetsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Praxis Dr. Howaldt
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Waikato Hospital
🇳🇿Hamilton, New Zealand
Azienda Ospedaliera - Universita di Padova
🇮🇹Padova, Italy
Shakespeare Specialist Group
🇳🇿Milford, Auckland, New Zealand
Clinical Research Centre
🇬🇧London, United Kingdom
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Digestive Health Research Unit
🇺🇸Scottsdale, Arizona, United States
Adobe Surgery Center
🇺🇸Tucson, Arizona, United States
Rocky Mountain Gastroenterology Associates
🇺🇸Lakewood, Colorado, United States
Rocky Mountain Gastroenterology
🇺🇸Littleton, Colorado, United States
Rocky Mountain Clinical Research, LLC.
🇺🇸Wheat Ridge, Colorado, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Gastroenterology Consultants of Clearwater
🇺🇸Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Gastroenterology Associates
🇺🇸Crystal River, Florida, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Atlanta Center for Gastroenterology, P.C.
🇺🇸Decatur, Georgia, United States
Suncoast Endoscopy Center
🇺🇸Inverness, Florida, United States
International Clinical Research - US, LLC
🇺🇸Sanford, Florida, United States
Gastointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
The Atlanta Center For Gastroenterology
🇺🇸Decatur, Georgia, United States
Illinois Gastroenterology Group, LLC
🇺🇸Arlington Heights, Illinois, United States
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Digestive Disorders Associates
🇺🇸Annapolis, Maryland, United States
Drgestive Disorders Associates
🇺🇸Annapolis, Maryland, United States
East Valley Endoscopy
🇺🇸Grand Rapids, Michigan, United States
Gastroenterology Associates of Western Michigan
🇺🇸Wyoming, Michigan, United States
Metro Health Hospital Endoscopy Unit
🇺🇸Wyoming, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Huron Gastroenterology Associates
🇺🇸Ypsilanti, Michigan, United States
Weill Cornell Medical College of Cornell University
🇺🇸New York, New York, United States
Present, Chapman, Steinlauf and Marion
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
🇺🇸New York, New York, United States
Weill Cornell Imaging at New York Presbyterian Hospital
🇺🇸New York, New York, United States
Weill Cornell Medical College of Cornell University-Greenberg
🇺🇸New York, New York, United States
Arthur Asher Kombluth, MD PC
🇺🇸New York, New York, United States
Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Pittsburgh Gastroenterology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Research Protocol Management Specialists
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center-GI Research
🇺🇸Nashville, Tennessee, United States
Diagnostic Clinic of Houston, PA
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center: IBD Clinic
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center-IDS
🇺🇸Nashville, Tennessee, United States
IBD Center-Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Diagnostic Clinic Of Houston Pa
🇺🇸Houston, Texas, United States
The University of TX Health Sci. Ctr at Houston
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
St. Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Chu St Pierre
🇧🇪Bruxelles, Belgium
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
ðŸ‡ðŸ‡ºDebrecen, Hungary
National Virus Reference Laboratory
🇮🇪Dublin, Ireland
Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
🇮🇪Dublin, Ireland
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)
🇮🇱Jerusalem, Israel
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Bispebjerg Hospital
🇩🇰Koebenhavn NV, Denmark
Rigshospitalet
🇩🇰Koebenhavn, Denmark
Medicinsk Afdeling, Gastroenterologisk Sektion
🇩🇰Koege, Denmark
H.-Hartziekenhuis Roeselare-Menen vzw
🇧🇪Roeselare, Belgium
Clinfan Kft.
ðŸ‡ðŸ‡ºSzekszard, Hungary
University Hospital Galway
🇮🇪Galway, Ireland
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
ðŸ‡ðŸ‡ºSzeged, Hungary
St. Vincents University Hospital
🇮🇪Dublin, Ireland
Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin Medical Center, Beilinson Hospital
🇮🇱Petah Tikva, Israel
Eastern Health, Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
CHU Saint-Pierre
🇧🇪Bruxelles, Belgium
University Hospital Leuven, Campus Gasthuisberg
🇧🇪Leuven, Belgium
Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group
🇮🇪Dublin, Ireland
Institute of Gastroenterology
🇮🇱Haifa, Israel
Universitaetsspital Zuerich
🇨ðŸ‡Zuerich, Switzerland
Pannonia Maganorvosi Centrum Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Digestive Disease Institute
🇮🇱Beith Vagan, Jerusalem, Israel
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States
Colonoscopy and X-rays: OU Physicians Building
🇺🇸Oklahoma City, Oklahoma, United States
Pharmacy: Wheeler and Stuckey, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Istituto Clinico Humanitas IRCCS
🇮🇹Rozzano, Milano, Italy
AOS San Camillo Forlanini
🇮🇹Rome, Italy
Hopital Saint-Antoine - Service De Gastroenterologie
🇫🇷Paris, Cedex 12, France
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
St Bartholomew's Hospital (Barts Health NHS Trust)
🇬🇧London, United Kingdom
Montreal General Hospital - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Clinical Pathologiy Laboratories, Inc, DBA DRL Labs
🇺🇸Tyler, Texas, United States
U of L Health Care Outpatient Center
🇺🇸Louisville, Kentucky, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
Professional Quality Research, Inc.
🇺🇸Austin, Texas, United States
VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]
🇺🇸Richmond, Virginia, United States
Austin Gastroenterology, PA
🇺🇸Austin, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Rocky Mountain Clinical Research, LLC
🇺🇸Wheat Ridge, Colorado, United States
Simon Medical Imaging
🇺🇸Scottsdale, Arizona, United States