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A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy (ANDANTE)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04236921 SC injection
PF-04236921 SC injection
PF-04236921 SC injection
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, safety, efficacy, pharmacokinetics, pharmacodynamics, Crohn's Disease Activity Index (CDAI)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have failed or are intolerant to anti TNFs
  • 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:

  • Pregnant or breastfeeding women
  • Crohn's Disease with active fistulae or abscess
  • History of diverticulitis or symptomatic diverticulosis
  • Abnormality in hematology or chemistry profiles at screening

Sites / Locations

  • UAB Hospital
  • University of Alabama at Birmingham
  • Simon Medical Imaging
  • Digestive Health Research Unit
  • Adobe Clinical Research, Llc
  • Radiology Ltd
  • UCSF Endoscopy Unit at Mount Zion
  • University of California - San Francisco
  • University of California San Francisco at Mount Zion
  • Rocky Mountain Clinical Research, LLC
  • Rocky Mountain Gastroenterology Associates
  • Rocky Mountain Gastroenterology
  • Arapahoe Gastroenterology, PC
  • Endoscopy Center of Connecticut, LLC
  • Endoscopy Center of Connecticut, LLC
  • Gastroenterology Center of Connecticut, PC
  • Medical Research Center of Connecticut, LLC
  • Clinical Research of West Florida, Inc.
  • Gastroenterology Associates
  • Nature Coast Clinical Research
  • Suncoast Endoscopy Center
  • Advanced Research Institute, Inc.
  • International Clinical Research - US, LLC
  • Atlanta Center for Gastroenterology, P.C.
  • Atlanta Endoscopy Center
  • Decatur Health Imaging
  • Gastrointestinal Specialists of Georgia, PC
  • GI Diagnostics
  • Illinois Gastroenterology Group, LLC
  • The University of Chicago Medical Center (Ucmc)
  • The University of Chicago Medical Center
  • The University of Chicago Medical
  • The University Of Chicago
  • NorthShore University Health System
  • Glenbrook Hospital Outpatient Pharmacy
  • Glenbrook Hospital
  • Central Indiana Gastroenterology Group
  • Saint John's Research Institute
  • University of Kentucky
  • University Of Louisville Healthcare Outpatient Center
  • University of Louisville Research Foundation
  • University Of Louisville
  • Digestive Disorders Associates
  • Disgestive Disorders Associates
  • Investigative Clinical Research
  • Maryland Diagnostics & Therapeutic Endo Center
  • Commonwealth Clinical Studies
  • Prima CARE, PC
  • St. Joseph Mercy Hospital
  • East Valley Endoscopy
  • Gastroenterology Associates of Western Michigan
  • Metro Health Hospital Endoscopy Unit
  • Metro Health Hospital
  • Huron Gastroenterology Associates
  • St. Joseph Mercy Hospital
  • Minnesota Gastroenterology, PA
  • Weill Cornell Medical College of Cornell University-Greenberg
  • Weill Cornell Medical College of Cornell University
  • Present Chapman, Steinlauf and Marion
  • Mount Sinai School of Medicine
  • New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
  • New York Presbyterian Hospital
  • Weill Cornell Imaging at New York Presbyterian Hospital
  • Arthur asher Kornbluth, MD PC
  • PMG Research of Winston-Salem
  • Oklahoma Foundation for Digestive Research
  • Pharmacy: Wheeler and Stuckey, Inc.
  • Colonoscopy and X-rays: OU Physicians Building
  • Hillcrest Medical Center Endoscopy
  • Hillcrest Medical Center
  • Options Health Research, LLC
  • Utica Park Clinic X-Ray
  • Advanced Imaging
  • Pittsburgh Gastroenterology Associates
  • Research Protocol Management Specialists
  • Pharma Resource
  • Omega Medical Research
  • Gastro One
  • Vanderbilt University Medical Center
  • Professional Quality Research, Inc.
  • Diagnostic Clinic of Houston, PA
  • Houston Hospital for Specialized Surgery (Endoscopy Only)
  • Baylor Clinic (Drug Storage)
  • Baylor College of Medicine - Baylor Medical Center
  • Ertan Digestive Disease Center
  • Memorial Hermann Hospital
  • The University of Texas Health Science Center at Houston
  • The University of Texas Medical School at Houston
  • Physicians Endoscopy Center (Colonoscopy)
  • Texas Digestive Disease Consultants
  • One Step Diagnostic (X-Ray)
  • Pioneer Research Solutions, Inc. (Admin. Office)
  • Pioneer Research Solutions, Inc.
  • Digestive Health Specialists of Tyler
  • University Of Utah HSC
  • Virginia Commonwealth University
  • Virginia Commonwealth University
  • VCU Medical Investigational Drug Service (IDS)
  • Concord Repatriation General Hospital
  • Nepean Public Hospital
  • Royal Brisbane and Women's Hospital
  • Mater Health Services
  • Eastern Health, Box Hill Hospital
  • Monash Medical Centre
  • The Royal Melbourne Hospital
  • St. Vincent's Hospital Melbourne
  • University Hospital Leuven
  • CHU Saint-Pierre
  • UZ Leuven Pharmacy
  • An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw
  • Clinica do Coracao Samaritano
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
  • Center X Diagnosticos
  • Hospital Universitário Fraga Filho da UFRJ
  • Hospital Sao Lucas da PUCRS
  • Faculdade de Medicina do ABC
  • Hospital Israelita Albert Einstein
  • Hospital Nossa Senhora das Gracas
  • Heritage Medical Research Clinic - University of Calgary
  • London Health Science Centre - University Hospital
  • Mount Sinai Hospital
  • McGill University Health Centre - Royal Victoria Hospital
  • Hepato-Gastroenterologie HK, s.r.o.
  • Medial Pharma s.r.o.,
  • Fakultni nemocnice Olomouc
  • Klinicke centrum ISCARE I.V.F. - gastroenterologie
  • Fakultni nemocnice Kralovske Vinohrady
  • Institut klinicke a experimentalni mediciny
  • IBD Clinical and Research centre
  • Krajska zdravotni, a.s.
  • Aalborg Sygehus
  • Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital
  • Gastroenheden
  • Kirurgisk Afdeling 0143
  • Hvidovre Hospital
  • Afdeling I, Gastroenterologisk Sektion
  • Rigshospitalet
  • Medicinsk Afdeling, Gastroenterologisk Sektion
  • Hopital Huriez, CHRU de Lille
  • Hopital Saint-Antoine - Service De Gastroenterologie
  • Hopital de Brabois
  • Medizinische Hochschule Hannover
  • "Charite - Campus Benjamin Franklin
  • Praxis Dr. Howaldt
  • Universitaetsklinikum Schleswig-Holstein
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Universitaetsklinik Regensburg
  • University General Hospital "Attikon"
  • General Hospital of Athens "Evangelismos",1st Gastroenterology Department
  • Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai
  • Pannonia Maganorvosi Centrum Kft.
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
  • Clinfan Kft.
  • St. Vincents University Hospital
  • Beaumont Hospital
  • National Virus Reference Laboratory
  • Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group
  • Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
  • University Hospital Galway
  • The Institute Of Gastroenterology & Liver Diseases
  • Institute of Gastroenterology
  • The E. Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center
  • Dept of Gastroenterology & Hepatology
  • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva
  • Istituto Clinico Humanitas IRCCS
  • A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and
  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
  • Azienda Ospedaliera - Universita di Padova
  • Università Campus Biomedico
  • Policlinico Tor Vergata
  • Azienda Ospedaliera San Camillo Forlanini
  • Shakespeare Specialist Group
  • Christchurch Hospital
  • Department of Gastroenterology Research
  • P3 Research Limited
  • Spitalul Clinic Colentina
  • Universitaetsspital Zuerich
  • Hull and East Yorkshire Hospitals NHS Trust
  • Addenbrooke's Hospital, Department of Gastroenterology
  • Glasgow Royal Infirmary
  • Pharmacy Department
  • Barts and The London NHS Trust
  • Royal Free Hospital (Royal Free London NHS Foundation Trust)
  • Royal Victoria Hospital
  • New Cross Hospital
  • Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo- SC injection

Drug Dose level 1 - SC injection

Drug Dose level 2 - SC injection

Arm Description

Outcomes

Primary Outcome Measures

The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.

Secondary Outcome Measures

The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32.
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.
Serum PF-04236921 Concentration Over Time
Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Full Information

First Posted
January 31, 2011
Last Updated
December 14, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01287897
Brief Title
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Acronym
ANDANTE
Official Title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, safety, efficacy, pharmacokinetics, pharmacodynamics, Crohn's Disease Activity Index (CDAI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo- SC injection
Arm Type
Placebo Comparator
Arm Title
Drug Dose level 1 - SC injection
Arm Type
Experimental
Arm Title
Drug Dose level 2 - SC injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-04236921 SC injection
Intervention Description
Placebo delivered SC, 2 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04236921 SC injection
Intervention Description
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04236921 SC injection
Intervention Description
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Primary Outcome Measure Information:
Title
The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Description
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Time Frame
Baseline and Week 8
Title
The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
Description
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.
Time Frame
Baseline and Week 8
Title
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Description
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Time Frame
Baseline and Week 12
Title
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
Description
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Description
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Time Frame
Baseline and Weeks 2, 4, 6, and 10
Title
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Description
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.
Time Frame
Baseline and Weeks 2, 4, 6, and 10
Title
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Description
CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Time Frame
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Title
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Description
CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.
Time Frame
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Title
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Description
CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Time Frame
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Title
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Description
CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.
Time Frame
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Title
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Description
CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Time Frame
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Title
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Description
CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.
Time Frame
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Title
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Description
The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32.
Time Frame
At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
Title
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Description
The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.
Time Frame
At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
Title
Serum PF-04236921 Concentration Over Time
Time Frame
Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40
Title
Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)
Description
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have failed or are intolerant to anti TNFs 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: Pregnant or breastfeeding women Crohn's Disease with active fistulae or abscess History of diverticulitis or symptomatic diverticulosis Abnormality in hematology or chemistry profiles at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Simon Medical Imaging
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Digestive Health Research Unit
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Adobe Clinical Research, Llc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Radiology Ltd
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
UCSF Endoscopy Unit at Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California San Francisco at Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Rocky Mountain Clinical Research, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Rocky Mountain Gastroenterology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Arapahoe Gastroenterology, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Gastroenterology Center of Connecticut, PC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Gastroenterology Associates
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Suncoast Endoscopy Center
City
Inverness
State/Province
Florida
ZIP/Postal Code
34453
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
International Clinical Research - US, LLC
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Atlanta Center for Gastroenterology, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Atlanta Endoscopy Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Decatur Health Imaging
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
GI Diagnostics
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Illinois Gastroenterology Group, LLC
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
The University of Chicago Medical Center (Ucmc)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Chicago Medical
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Glenbrook Hospital Outpatient Pharmacy
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Central Indiana Gastroenterology Group
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Saint John's Research Institute
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University Of Louisville Healthcare Outpatient Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Research Foundation
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Digestive Disorders Associates
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Disgestive Disorders Associates
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Investigative Clinical Research
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Maryland Diagnostics & Therapeutic Endo Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Commonwealth Clinical Studies
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Prima CARE, PC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
East Valley Endoscopy
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Metro Health Hospital Endoscopy Unit
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Huron Gastroenterology Associates
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minnesota Gastroenterology, PA
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Weill Cornell Medical College of Cornell University-Greenberg
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Present Chapman, Steinlauf and Marion
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Imaging at New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Arthur asher Kornbluth, MD PC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Pharmacy: Wheeler and Stuckey, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Colonoscopy and X-rays: OU Physicians Building
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hillcrest Medical Center Endoscopy
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Utica Park Clinic X-Ray
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Advanced Imaging
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137-4200
Country
United States
Facility Name
Pittsburgh Gastroenterology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Research Protocol Management Specialists
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Pharma Resource
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Professional Quality Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Diagnostic Clinic of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Houston Hospital for Specialized Surgery (Endoscopy Only)
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Baylor Clinic (Drug Storage)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ertan Digestive Disease Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Physicians Endoscopy Center (Colonoscopy)
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
One Step Diagnostic (X-Ray)
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Pioneer Research Solutions, Inc. (Admin. Office)
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
SugarLand
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University Of Utah HSC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0341
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
VCU Medical Investigational Drug Service (IDS)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
93298-5028
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Nepean Public Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston, Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Health Services
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Eastern Health, Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
VIC 3065
Country
Australia
Facility Name
University Hospital Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Saint-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Leuven Pharmacy
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw
City
Roeselare
ZIP/Postal Code
B-8800
Country
Belgium
Facility Name
Clinica do Coracao Samaritano
City
Goiania
State/Province
GO
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
City
Goiania
State/Province
GO
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
Center X Diagnosticos
City
Goiania
State/Province
GO
ZIP/Postal Code
74535-900
Country
Brazil
Facility Name
Hospital Universitário Fraga Filho da UFRJ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
SP
ZIP/Postal Code
05651-901
Country
Brazil
Facility Name
Hospital Nossa Senhora das Gracas
City
Curitiba
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Heritage Medical Research Clinic - University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
London Health Science Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
McGill University Health Centre - Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czech Republic
Facility Name
Medial Pharma s.r.o.,
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czech Republic
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Klinicke centrum ISCARE I.V.F. - gastroenterologie
City
Prague
ZIP/Postal Code
170 04
Country
Czech Republic
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Institut klinicke a experimentalni mediciny
City
Praha 4
ZIP/Postal Code
14021
Country
Czech Republic
Facility Name
IBD Clinical and Research centre
City
Praha 7
Country
Czech Republic
Facility Name
Krajska zdravotni, a.s.
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
Aalborg Sygehus
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Gastroenheden
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Kirurgisk Afdeling 0143
City
Hilleroed
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Afdeling I, Gastroenterologisk Sektion
City
Koebenhavn NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Rigshospitalet
City
Koebenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Medicinsk Afdeling, Gastroenterologisk Sektion
City
Koege
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Hopital Huriez, CHRU de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Saint-Antoine - Service De Gastroenterologie
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital de Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
"Charite - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Praxis Dr. Howaldt
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Universitaetsklinik Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
University General Hospital "Attikon"
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
City
Kolonaki Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft.
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Clinfan Kft.
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
St. Vincents University Hospital
City
Dublin 4
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
National Virus Reference Laboratory
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland
Facility Name
Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland
Facility Name
Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Facility Name
The Institute Of Gastroenterology & Liver Diseases
City
Tel Hashomer
State/Province
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Institute of Gastroenterology
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
The E. Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Dept of Gastroenterology & Hepatology
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva
City
San Giovanni Rotondo Fg
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Clinico Humanitas IRCCS
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and
City
Rome
State/Province
Province of Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera - Universita di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Università Campus Biomedico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00151
Country
Italy
Facility Name
Shakespeare Specialist Group
City
Milford
State/Province
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Department of Gastroenterology Research
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
P3 Research Limited
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
State/Province
Sector 2
ZIP/Postal Code
020125
Country
Romania
Facility Name
Universitaetsspital Zuerich
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital, Department of Gastroenterology
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G40SS
Country
United Kingdom
Facility Name
Pharmacy Department
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Barts and The London NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free Hospital (Royal Free London NHS Foundation Trust)
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV69AT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29776017
Citation
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.
Results Reference
derived
PubMed Identifier
29247068
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0151003&StudyName=A%20Study%20To%20Assess%20The%20Efficacy%20And%20Safety%20Of%20PF-04236921%20In%20Subjects%20With%20Crohn%27s%20Disease%20Who%20Failed%20Anti-TNF%20Therapy
Description
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Learn more about this trial

A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

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