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A Study To Monitor Long-Term Treatment With PF-00547659 (OPERA II)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-00547659
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 Active Crohn's disease, Anti-TNF Refractory, Immunosuppressant Refractory

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects between 18 and 76 years of age.
  • Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed Week 12 and have demonstrated a clinical response as defined by that protocol.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would hinder entry or participation in this study.
  • Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.

Sites / Locations

  • UCSD Medical Center - Thorton Hospital
  • Community Clinical Trials
  • GastroDiagnostics
  • Clinical Research of the Rockies
  • Rmga - Rmcr
  • Rocky Mountain Gastroenterology Associates
  • MGG Group Co., Inc.
  • Florida Center for Gastroenterology
  • Sylvester Comprehensive Cancer Center
  • University of Miami Crohn's and Colitis Center
  • University of Miami Hospital and Clinic (IP Shipment Only)
  • University of Miami Hospital and Clinic
  • University of Miami Hospital
  • Citrus Ambulatory Surgery Center
  • Internal Medicine Specialists
  • Heartland Medical Research, Inc.
  • 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
  • Surgery Center of Columbia
  • Audrain Medical Center
  • Center for Digestive and Liver Diseases, Inc.
  • Barnes-Jewish Hospital - Investigational Drug Services
  • Barnes-Jewish Hospital
  • Center for Advanced Medicine
  • Washington University School of Medicine
  • Albany Medical College
  • 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.
  • Lenox Hill Endoscopy Center
  • Synergy First
  • Premier Medical Group of the Hudson Valley, PC
  • CTRC Hospital, UNC Memorial Hospital
  • North Carolina Memorial Hospital Endoscopy Center
  • UNC Hospitals
  • UNC Hospitals Endoscopy
  • Hillsborough Campus
  • University of Washington Medical Center
  • University of Washington
  • Allegiance Research Specialists
  • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • AKH Wien
  • Hospital Erasme
  • UZ Gasthuisberg - Pharmacy
  • UZ Gasthuisberg
  • Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman
  • Centre Hospitalier de Mouscron
  • Oshawa Clinic
  • Toronto Digestive Disease Associates Inc.
  • Hopital Beaujon
  • Hopital Huriez, CHRU de Lille
  • CHRU de Lille, Pharamcie Centrale
  • CIC - Hopital Cardiologique
  • Hopital de l'Archet 2 - CHU de Nice
  • Hopital Saint-Louis
  • Hopital Nord
  • Hopital Rangueil
  • Robert Bosch Krankenhaus GmbH
  • Universitaetsklinikum Ulm
  • "Charite - Campus Berlin Mitte Medizinische Klinik
  • Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
  • Krankenhaus Martha-Maria Halle-Doelau gGmbH
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Universitaetsfrauenklinikum Schleswig-Holstein
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Universitaetsklinik Regensburg
  • National Hospital Organization Takasaki General Medical Center
  • Yokohama City University Medical Center
  • The Jikei University Hospital
  • Keio University Hospital
  • National Hospital Organization Hirosaki National Hospital
  • Chiba University Hospital
  • Pusan National University Hospital
  • Yeungnam University Hospital
  • Samsung Medical Center
  • Kangbuk Samsung Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Academic Medical Center
  • University Medical Center Groningen
  • Maastricht University Medical Center
  • Sykehusapoteket Asker og Baerum
  • Oslo Universitetssykehus
  • Lovisenberg Diakonale Sykehus
  • Vestre Viken HF
  • Centrum Endoskopii Zabiegowej
  • NZOZ Centrum Medyczne Szpital Sw. Rodziny
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie
  • Lexmedica
  • Military Medical Academy
  • Clinical Hospital Centre Bezanijska Kosa
  • Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology
  • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
  • Medak s.r.o.
  • KM Management spol. s r.o.
  • Synergy group, a.s.
  • Wits Clinical Research
  • Parklands Medical Centre
  • Kingsbury Hospital
  • Corporacio Sanitaria Parc Tauli de Sabadell
  • Corporacio Sanitaria Parc Tauli de Sabadell
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Universitario de La Princesa
  • Hospital General Universitario Gregorio Maranon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Treatment

Arm Description

Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008

Outcomes

Primary Outcome Measures

Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.

Secondary Outcome Measures

Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points.
Serum Trough Concentrations of PF-00547659 Versus Time
Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.

Full Information

First Posted
January 26, 2011
Last Updated
May 11, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01298492
Brief Title
A Study To Monitor Long-Term Treatment With PF-00547659
Acronym
OPERA II
Official Title
A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
July 27, 2016 (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
This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.
Detailed Description
The rationale for conducting this open-label extension (OLE) study is primarily to evaluate long term safety of PF 00547659. This protocol also provides the opportunity for continued treatment for subjects responding to treatment from the feeder study. It also provides an opportunity for initial treatment for subjects randomized to placebo in the feeder study. This is a multi center Phase 2, open label, safety extension study for feeder studies which evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 with a clinical response, as defined by that protocol, will also be eligible for this study and treated as "responders". All subjects entering this study must have discontinued immunosuppressant therapy. Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4 weeks through Week 72. After the active treatment period, the subjects will enter a 24 month follow up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will continue the every 6 month telephone contacts until Week 168.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Active Crohn's disease, Anti-TNF Refractory, Immunosuppressant Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Treatment
Arm Type
Experimental
Arm Description
Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008
Intervention Type
Drug
Intervention Name(s)
PF-00547659
Intervention Description
75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.
Primary Outcome Measure Information:
Title
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
Description
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.
Time Frame
From start of study treatment up to Week 72 (Treatment Period)
Secondary Outcome Measure Information:
Title
Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
Description
Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points.
Time Frame
Baseline up to Week 96
Title
Serum Trough Concentrations of PF-00547659 Versus Time
Description
Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.
Time Frame
Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96

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 between 18 and 76 years of age. Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed Week 12 and have demonstrated a clinical response as defined by that protocol. Exclusion Criteria: Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would hinder entry or participation in this study. Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Medical Center - Thorton 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
GastroDiagnostics
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical Research of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Rmga - Rmcr
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
MGG Group Co., Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
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 Crohn's and Colitis Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital and Clinic (IP Shipment Only)
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
Citrus Ambulatory 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, Inc.
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
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
63108
Country
United States
Facility Name
Barnes-Jewish Hospital
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
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
Lenox Hill Endoscopy Center
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Synergy First
City
New York
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley, PC
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
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
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Washington
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
AKH Wien Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital Erasme
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
UZ Gasthuisberg - Pharmacy
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Centre Hospitalier de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
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
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Huriez, CHRU de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU de Lille, Pharamcie Centrale
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CIC - Hopital Cardiologique
City
Lille
ZIP/Postal Code
59037
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 Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Nord
City
St Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Hopital Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Robert Bosch Krankenhaus GmbH
City
Stuttgart
State/Province
Baden-wuerttemberg
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden-wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
"Charite - Campus Berlin Mitte Medizinische Klinik
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Doelau gGmbH
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsfrauenklinikum Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Universitaetsklinik Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
The 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
National Hospital Organization Hirosaki National Hospital
City
Aomori
State/Province
Toyko
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
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
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
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
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Sykehusapoteket Asker og Baerum
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
Vestre Viken HF
City
Rud
ZIP/Postal Code
1309
Country
Norway
Facility Name
Centrum Endoskopii Zabiegowej
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
NZOZ Centrum Medyczne Szpital Sw. Rodziny
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
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 Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology
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
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, South Africa
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
Corporacio Sanitaria Parc Tauli de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli de Sabadell
City
Sabadell
State/Province
Cataluna
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
34427633
Citation
D'Haens GR, Reinisch W, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Schreiber S, Il Park D, Hebuterne X, Nagy P, Cataldi F, Martin SW, Nayak S, Banerjee A, Gorelick KJ, Sandborn WJ. Long-Term Safety and Efficacy of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 Monoclonal Antibody Ontamalimab (SHP647) for the Treatment of Crohn's Disease: The OPERA II Study. Inflamm Bowel Dis. 2022 Jul 1;28(7):1034-1044. doi: 10.1093/ibd/izab215.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7281007&StudyName=A%20Study%20To%20Monitor%20Long-Term%20Treatment%20With%20PF-00547659
Description
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A Study To Monitor Long-Term Treatment With PF-00547659

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