A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
NCT ID: NCT01287897
Last Updated: 2016-01-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2011-02-28
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
NCT01276509
Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
NCT05471492
Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease
NCT04151225
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
NCT03395184
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
NCT02405442
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo- SC injection
PF-04236921 SC injection
Placebo delivered SC, 2 doses separated by 4 weeks
Drug Dose level 1 - SC injection
PF-04236921 SC injection
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
Drug Dose level 2 - SC injection
PF-04236921 SC injection
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-04236921 SC injection
Placebo delivered SC, 2 doses separated by 4 weeks
PF-04236921 SC injection
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
PF-04236921 SC injection
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* hsCRP greater or equal to 5.0 mg/L
* Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening
Exclusion Criteria
* Crohn's Disease with active fistulae or abscess
* History of diverticulitis or symptomatic diverticulosis
* Abnormality in hematology or chemistry profiles at screening
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UAB Hospital
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Simon Medical Imaging
Scottsdale, Arizona, United States
Digestive Health Research Unit
Scottsdale, Arizona, United States
Adobe Clinical Research, Llc
Tucson, Arizona, United States
Radiology Ltd
Tucson, Arizona, United States
UCSF Endoscopy Unit at Mount Zion
San Francisco, California, United States
University of California - San Francisco
San Francisco, California, United States
University of California San Francisco at Mount Zion
San Francisco, California, United States
Rocky Mountain Clinical Research, LLC
Denver, Colorado, United States
Rocky Mountain Gastroenterology Associates
Lakewood, Colorado, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States
Arapahoe Gastroenterology, PC
Littleton, Colorado, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 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
Suncoast Endoscopy Center
Inverness, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
International Clinical Research - US, LLC
Sanford, Florida, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States
Atlanta Endoscopy Center
Decatur, Georgia, United States
Decatur Health Imaging
Decatur, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
GI Diagnostics
Marietta, Georgia, United States
Illinois Gastroenterology Group, LLC
Arlington Heights, Illinois, United States
The University of Chicago Medical Center (Ucmc)
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
The University of Chicago Medical
Chicago, Illinois, United States
The University Of Chicago
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Glenbrook Hospital Outpatient Pharmacy
Glenview, Illinois, United States
Glenbrook Hospital
Glenview, Illinois, United States
Central Indiana Gastroenterology Group
Anderson, Indiana, United States
Saint John's Research Institute
Anderson, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
University Of Louisville Healthcare Outpatient Center
Louisville, Kentucky, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
University Of Louisville
Louisville, Kentucky, United States
Digestive Disorders Associates
Annapolis, Maryland, United States
Disgestive Disorders Associates
Annapolis, Maryland, United States
Investigative Clinical Research
Annapolis, Maryland, United States
Maryland Diagnostics & Therapeutic Endo Center
Annapolis, Maryland, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Prima CARE, PC
Fall River, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 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
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
Minnesota Gastroenterology, PA
Plymouth, Minnesota, United States
Weill Cornell Medical College of Cornell University-Greenberg
New York, New York, 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
New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Imaging at New York Presbyterian Hospital
New York, New York, United States
Arthur asher Kornbluth, MD PC
New York, New York, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Pharmacy: Wheeler and Stuckey, Inc.
Oklahoma City, Oklahoma, United States
Colonoscopy and X-rays: OU Physicians Building
Oklahoma City, Oklahoma, United States
Hillcrest Medical Center Endoscopy
Tulsa, Oklahoma, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
Utica Park Clinic X-Ray
Tulsa, Oklahoma, United States
Advanced Imaging
Tulsa, Oklahoma, United States
Pittsburgh Gastroenterology Associates
Pittsburgh, Pennsylvania, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Pharma Resource
East Providence, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Professional Quality Research, Inc.
Austin, Texas, United States
Diagnostic Clinic of Houston, PA
Houston, Texas, United States
Houston Hospital for Specialized Surgery (Endoscopy Only)
Houston, Texas, United States
Baylor Clinic (Drug Storage)
Houston, Texas, United States
Baylor College of Medicine - Baylor Medical Center
Houston, Texas, United States
Ertan Digestive Disease Center
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The University of Texas Medical School at Houston
Houston, Texas, United States
Physicians Endoscopy Center (Colonoscopy)
Houston, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
One Step Diagnostic (X-Ray)
Sugar Land, Texas, United States
Pioneer Research Solutions, Inc. (Admin. Office)
Sugar Land, Texas, United States
Pioneer Research Solutions, Inc.
SugarLand, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
University Of Utah HSC
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
VCU Medical Investigational Drug Service (IDS)
Richmond, Virginia, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Nepean Public Hospital
Kingswood, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Brisbane, Queensland, Australia
Mater Health Services
South Brisbane, Queensland, Australia
Eastern Health, Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
St. Vincent's Hospital Melbourne
Fitzroy, , Australia
University Hospital Leuven
Leuven, Vlaams Brabant, Belgium
CHU Saint-Pierre
Brussels, , Belgium
UZ Leuven Pharmacy
Leuven, , Belgium
An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw
Roeselare, , Belgium
Clinica do Coracao Samaritano
Goiânia, Goiás, Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
Goiânia, Goiás, Brazil
Center X Diagnosticos
Goiânia, Goiás, Brazil
Hospital Universitário Fraga Filho da UFRJ
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Hospital Nossa Senhora das Gracas
Curitiba, , Brazil
Heritage Medical Research Clinic - University of Calgary
Calgary, Alberta, Canada
London Health Science Centre - University Hospital
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, Canada
Klinicke centrum ISCARE I.V.F. - gastroenterologie
Prague, Prague, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Medial Pharma s.r.o.,
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Institut klinicke a experimentalni mediciny
Prague, , Czechia
IBD Clinical and Research centre
Prague, , Czechia
Krajska zdravotni, a.s.
Ústí nad Labem, , Czechia
Aalborg Sygehus
Aalborg, , Denmark
Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital
Aarhus C, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Gastroenheden
Herlev, , Denmark
Kirurgisk Afdeling 0143
Hilleroed, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Afdeling I, Gastroenterologisk Sektion
Koebenhavn NV, , Denmark
Medicinsk Afdeling, Gastroenterologisk Sektion
Koege, , Denmark
Hopital Huriez, CHRU de Lille
Lille, , France
Hopital Saint-Antoine - Service De Gastroenterologie
Paris, , France
Hopital de Brabois
Vandœuvre-lès-Nancy, , France
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
"Charite - Campus Benjamin Franklin
Berlin, , Germany
Praxis Dr. Howaldt
Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , Germany
Universitaetsklinik Regensburg
Regensburg, , Germany
University General Hospital "Attikon"
Athens, , Greece
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, , Greece
Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika
Budapest, , Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai
Budapest, , Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, , Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
Szeged, , Hungary
Clinfan Kft.
Szekszárd, , Hungary
Beaumont Hospital
Dublin, , Ireland
National Virus Reference Laboratory
Dublin, , Ireland
Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group
Dublin, , Ireland
Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
Dublin, , Ireland
St. Vincents University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
The Institute Of Gastroenterology & Liver Diseases
Tel Litwinsky, Ramat Gan, Israel
Institute of Gastroenterology
Haifa, , Israel
The E. Wolfson Medical Center
Holon, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Dept of Gastroenterology & Hepatology
Kfar Saba, , Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva
San Giovanni Rotondo Fg, Foggia, Italy
Istituto Clinico Humanitas IRCCS
Rozzano, Milano, Italy
Azienda Ospedaliera - Universita di Padova
Padua, Padova, Italy
A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and
Rome, Province of Rome, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Università Campus Biomedico
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Shakespeare Specialist Group
Milford, Auckland, New Zealand
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Department of Gastroenterology Research
Hamilton, Waikato Region, New Zealand
P3 Research Limited
Wellington, , New Zealand
Spitalul Clinic Colentina
Bucharest, Sector 2, Romania
Universitaetsspital Zuerich
Zurich, , Switzerland
Hull and East Yorkshire Hospitals NHS Trust
Hull, East Yorkshire, United Kingdom
Addenbrooke's Hospital, Department of Gastroenterology
Cambridge, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Pharmacy Department
Hull, , United Kingdom
Barts and The London NHS Trust
London, , United Kingdom
Royal Free Hospital (Royal Free London NHS Foundation Trust)
London, , United Kingdom
Royal Victoria Hospital
Newcastle upon Tyne, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-023034-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANDANTE
Identifier Type: OTHER
Identifier Source: secondary_id
B0151003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.