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Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease (OPERA)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-00547659 SC injection
PF-00547659 SC injection
PF-00547659 SC injection
PF-00547659 SC injection
Sponsored by
Shire
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 and/or immunosuppressants (AZA, 6-MP, and/or MTX).
  • hsCRP greater than 3mg/L
  • Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria:

  • Pregnant or breast feeding
  • Short bowel syndrome due to multiple small bowel resections
  • Presence of a stoma

Sites / Locations

  • Clopton Clinic
  • Gastroenterology Specialists of Arkansas
  • Little Rock Diagnostic Clinic, P.A.
  • UCSD Medical Center-Thornton Hospital
  • Community Clinical Trials
  • Gastro Diagnostics
  • Inland Gastroenterology Medical Associates, Inc.
  • BioMark Research Inc.
  • Clinical Research of the Rockies
  • Rocky Mountain Gastroenterology Associates
  • Connecticut Clinical Research Foundation
  • Shands Endoscopy Center
  • Shands Hospital at the University of Florida
  • Shands Medical Plaza
  • Mayo Clinic Jacksonville
  • Florida Center for Gastroenterology
  • Sylvester Comprehensive Cancer Center
  • University of Miami Hospital and Clinic
  • University of Miami Hospital
  • University of Miami
  • Cirtus Ambulartory Surgery Center
  • Internal Medicine Specialists
  • Heartland Medical Research (Administrative Only)
  • Iowa Digestive Disease Center
  • Iowa Endoscopy Center (Colonoscopy Only)
  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
  • UMass Memorial Medical Center
  • University of Massachusetts Worcester
  • Center for Digestive Health
  • Surgical Centers of Michigan
  • Minneapolis Heart Institute, West Health Campus
  • Noran Neurology Clinic
  • Consulting Radiology (Xray testing only)
  • Minnesota Gastroenterology, P.A.
  • Mayo Clinic
  • Surgery Center of Columbia
  • Audrain Medical Center
  • Center for Digestive and Liver Diseases, Inc.
  • Barnes-Jewish Hospital - Investigational Drug Services
  • Center for Advanced Medicine
  • Washington University School of Medicine
  • Albany Medical College
  • Life Medi-Research And Management
  • New York Hospital Queens
  • Long Island Clinical Research Associates, LLP
  • Nassau Gastroenterology Associates Office Based Surgery
  • Nassau Gastroenterology Associates, P.C.
  • North Shore Primary Care, P.C.
  • Beth Israel Medical Center - Phillip Ambulatory Care Center
  • East side Endoscopy, LLC (for colonscopy testing only)
  • Lenox Hill Endoscopy Center
  • Premier Medical Group of the Hudson Valley
  • CTRC Hospital - UNC Memorial Hospital
  • North Carolina Memorial Hospital Endoscopy Center
  • UNC Hospitals Department of Pharmacy
  • UNC Hospitals Endoscopy
  • Hillsborough Campus
  • Thomas Jefferson University Hospital
  • The Offices of Dr. Vincent Armenio, M.D.
  • Pharma Resource
  • Bayside Endoscopy Center
  • Nashville Medical Research Institute
  • Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center
  • University of Utah HSC
  • Charlottesville Gastroenterology Associates
  • Charlottesville Medical Research
  • University of Washington Medical Center
  • Allegiance Research Specialists
  • GI Associates
  • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • UZ Gasthuisberg
  • Centre Hospitalier Universitaire de Liege
  • Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique
  • Centre Hospitalier de Mouscron
  • 4-MHAT
  • MBAL Sofiamed OOD,Otdelenie po gastroenterologia
  • Vancouver Coastal Health - Vancouver General Hospital
  • Vancouver Coastal Health - Vancouver Hospital
  • Oshawa Clinic
  • Toronto Digestive Disease Associates Inc.
  • CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie
  • Hopital Saint-Andre
  • Hopital Beaujon- Essais cliniques
  • Hopital de l'Archet 2 - CHU de Nice
  • Hopital Cochin-Essais Cliniques
  • Hopital Charles Nicolle
  • Hopital Nord
  • Hopital Rangueil
  • Charite - Campus Berlin Mitte Medizinische Klinik
  • Krankenhaus Martha-Maria Halle-Doelau gGmbH
  • Universitaetsklinikum Schleswig-Holstein
  • Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Universitaetsklinikum Regensburg
  • Robert-Bosch-Krankenhaus
  • Universitaetklinikum Ulm
  • National Hospital Organization Hirosaki National Hospital
  • National Hospital Organization Takasaki General Medical Center
  • Jikei University Hospital
  • Keio University Hospital
  • Aichi Medical University Hospital
  • Chiba University Hospital
  • Yokohama City University Medical Center
  • Pusan National University Hospital
  • Yeungnam University Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Yonsei University College of Medicine, Severance Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • University Medical Center Groningen (UMCG)
  • Academic Medical Center
  • Maastricht University Medical Center
  • Asker And Baerum Hospital
  • Oslo Universitetssykehus
  • Lovisenberg Diakonale Sykehus
  • Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej
  • Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie
  • Lexmedica
  • Military Medical Academy
  • Clinical Hospital Centre Bezanijska Kosa
  • Clinical Center Nis Clinic for Gastroenterology and Hepatology
  • Clinical Hospital Center Zemun
  • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
  • Medak s.r.o.
  • Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.
  • Synergy group, a.s.
  • Wits Clinical Research
  • Parklands Medical Centre
  • Kingsbury Hospital
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Clinic de Barcelona
  • Hospital Universitari Bellvitge
  • Hospital Universitario de La Princesa
  • Hospital General Universitario Gregorio Maranon
  • Corporacio Sanitaria Parc Tauli de Sabadell

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo-SC Injection

Drug Dose level 1- SC injection

Drug Dose level 2-SC injection

Drug Dose level 3- SC injection

Arm Description

Placebo delivered SC, 3 doses separated by 4 weeks.

Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.

Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.

Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate
Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.

Secondary Outcome Measures

Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo
Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.
Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo
Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.
Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission
Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).
Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time
Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.
Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer
Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.
Immunogenicity Assessment of Anti-drug Antibodies (ADAs)
Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)
The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.
The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.
The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.
The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.

Full Information

First Posted
January 12, 2011
Last Updated
May 11, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01276509
Brief Title
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
Acronym
OPERA
Official Title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2011 (Actual)
Primary Completion Date
February 7, 2014 (Actual)
Study Completion Date
October 9, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo-SC Injection
Arm Type
Placebo Comparator
Arm Description
Placebo delivered SC, 3 doses separated by 4 weeks.
Arm Title
Drug Dose level 1- SC injection
Arm Type
Experimental
Arm Description
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.
Arm Title
Drug Dose level 2-SC injection
Arm Type
Experimental
Arm Description
Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.
Arm Title
Drug Dose level 3- SC injection
Arm Type
Experimental
Arm Description
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC injection
Intervention Description
Placebo delivered SC, 3 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC injection
Intervention Description
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC injection
Intervention Description
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC injection
Intervention Description
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate
Description
Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.
Time Frame
Week 8 and week 12
Secondary Outcome Measure Information:
Title
Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo
Description
Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.
Time Frame
Week 0-12
Title
Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo
Description
Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.
Time Frame
Week 0-12
Title
Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission
Description
Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).
Time Frame
Weeks 8 and week 12
Title
Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time
Description
Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.
Time Frame
Week 2, 4, 6, 8, 10 and 12
Title
Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer
Description
Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.
Time Frame
Week 2, 4, 6, 8, 10 and 12
Title
Immunogenicity Assessment of Anti-drug Antibodies (ADAs)
Description
Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659
Time Frame
Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36
Title
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Description
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.
Time Frame
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
Title
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)
Description
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)
Time Frame
Day 1, 14, and 28
Title
The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)
Description
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.
Time Frame
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
Title
The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)
Description
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.
Time Frame
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
Title
The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)
Description
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.
Time Frame
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
Title
The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)
Description
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.
Time Frame
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

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 and/or immunosuppressants (AZA, 6-MP, and/or MTX). hsCRP greater than 3mg/L Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening Exclusion Criteria: Pregnant or breast feeding Short bowel syndrome due to multiple small bowel resections Presence of a stoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clopton Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Gastroenterology Specialists of Arkansas
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Little Rock Diagnostic Clinic, P.A.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UCSD Medical Center-Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Gastro Diagnostics
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Inland Gastroenterology Medical Associates, Inc.
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
BioMark Research Inc.
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Clinical Research of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Connecticut Clinical Research Foundation
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Shands Endoscopy Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Shands Medical Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Center for Gastroenterology
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital and Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
FL 33136
Country
United States
Facility Name
Cirtus Ambulartory Surgery Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Heartland Medical Research (Administrative Only)
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Endoscopy Center (Colonoscopy Only)
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Massachusetts Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Surgical Centers of Michigan
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Minneapolis Heart Institute, West Health Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Noran Neurology Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Consulting Radiology (Xray testing only)
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Surgery Center of Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Audrain Medical Center
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Center for Digestive and Liver Diseases, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Barnes-Jewish Hospital - Investigational Drug Services
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Life Medi-Research And Management
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
New York Hospital Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Nassau Gastroenterology Associates Office Based Surgery
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Nassau Gastroenterology Associates, P.C.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
North Shore Primary Care, P.C.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Beth Israel Medical Center - Phillip Ambulatory Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
East side Endoscopy, LLC (for colonscopy testing only)
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Lenox Hill Endoscopy Center
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
CTRC Hospital - UNC Memorial Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
North Carolina Memorial Hospital Endoscopy Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Hospitals Department of Pharmacy
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Hospitals Endoscopy
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Hillsborough Campus
City
Hillsborough
State/Province
North Carolina
ZIP/Postal Code
27278
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Offices of Dr. Vincent Armenio, M.D.
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Pharma Resource
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Bayside Endoscopy Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
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
Charlottesville Gastroenterology Associates
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GI Associates
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
AKH Wien Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Centre Hospitalier de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Facility Name
4-MHAT
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
MBAL Sofiamed OOD,Otdelenie po gastroenterologia
City
Sofia
ZIP/Postal Code
1979
Country
Bulgaria
Facility Name
Vancouver Coastal Health - Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver Coastal Health - Vancouver Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Oshawa Clinic
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie
City
Amiens Cedex 01
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Saint-Andre
City
Bordeaux cedex
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital Beaujon- Essais cliniques
City
Clichy Cedex
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital de l'Archet 2 - CHU de Nice
City
NICE Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Cochin-Essais Cliniques
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen Cedex 1
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital Nord
City
St Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Hopital Rangueil
City
Toulouse cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Charite - Campus Berlin Mitte Medizinische Klinik
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Doelau gGmbH
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Universitaetsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitaetklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
National Hospital Organization Hirosaki National Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine, Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
State/Province
GR
ZIP/Postal Code
9713GZ
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
NH
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Asker And Baerum Hospital
City
Gjettum
ZIP/Postal Code
1346
Country
Norway
Facility Name
Oslo Universitetssykehus
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Lovisenberg Diakonale Sykehus
City
Oslo
ZIP/Postal Code
0440
Country
Norway
Facility Name
Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Centre Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Nis Clinic for Gastroenterology and Hepatology
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical Hospital Center Zemun
City
Zemun
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
City
Bratislava
ZIP/Postal Code
831 04
Country
Slovakia
Facility Name
Medak s.r.o.
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Synergy group, a.s.
City
Nove Mesto Nad Vahom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
Wits Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Parklands Medical Centre
City
Durban
State/Province
Kwa-zulu - Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Kingsbury Hospital
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli de Sabadell
City
Sabadell
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32013314
Citation
Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.
Results Reference
derived
PubMed Identifier
28982740
Citation
Sandborn WJ, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Reinisch W, Hebuterne X, Park DI, Schreiber S, Nayak S, Ahmad A, Banerjee A, Brown LS, Cataldi F, Gorelick KJ, Cheng JB, Hassan-Zahraee M, Clare R, D'Haens GR. Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study. Gut. 2018 Oct;67(10):1824-1835. doi: 10.1136/gutjnl-2016-313457. Epub 2017 Oct 5.
Results Reference
derived
PubMed Identifier
28961803
Citation
Hassan-Zahraee M, Banerjee A, Cheng JB, Zhang W, Ahmad A, Page K, von Schack D, Zhang B, Martin SW, Nayak S, Reddy P, Xi L, Neubert H, Fernandez Ocana M, Gorelick K, Clare R, Vincent M, Cataldi F, Hung K. Anti-MAdCAM Antibody Increases ss7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):77-86. doi: 10.1093/ecco-jcc/jjx121.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7281006&StudyName=Study%20To%20Test%20Whether%20PF-00547659%20Is%20Safe%20And%20Improves%20Disease%20Symptoms%20In%20Patients%20With%20Crohn%27s%20Disease
Description
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Learn more about this trial

Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

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