Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
OPERA
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)
3 other identifiers
interventional
265
16 countries
137
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Typical duration for phase_2
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2011
CompletedStudy Start
First participant enrolled
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2015
CompletedResults Posted
Study results publicly available
April 13, 2017
CompletedJune 3, 2021
May 1, 2021
2.8 years
January 12, 2011
October 5, 2016
May 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 8 and week 12
Secondary Outcomes (12)
Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo
Week 0-12
Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo
Week 0-12
Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission
Weeks 8 and week 12
Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time
Week 2, 4, 6, 8, 10 and 12
Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer
Week 2, 4, 6, 8, 10 and 12
- +7 more secondary outcomes
Study Arms (4)
Placebo-SC Injection
PLACEBO COMPARATORPlacebo delivered SC, 3 doses separated by 4 weeks.
Drug Dose level 1- SC injection
EXPERIMENTALDrug dose level 1 delivered SC, 3 doses separated by 4 weeks.
Drug Dose level 2-SC injection
EXPERIMENTALDrug dose level 2 delievered SC, 3 doses separated by 4 weeks.
Drug Dose level 3- SC injection
EXPERIMENTALDrug dose level 3 delivered SC, 3 doses separated by 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or breast feeding
- Short bowel syndrome due to multiple small bowel resections
- Presence of a stoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (137)
Clopton Clinic
Jonesboro, Arkansas, 72401, United States
Gastroenterology Specialists of Arkansas
Jonesboro, Arkansas, 72401, United States
Little Rock Diagnostic Clinic, P.A.
Little Rock, Arkansas, 72205, United States
UCSD Medical Center-Thornton Hospital
La Jolla, California, 92037, United States
Community Clinical Trials
Orange, California, 92868, United States
Gastro Diagnostics
Orange, California, 92868, United States
Inland Gastroenterology Medical Associates, Inc.
Redlands, California, 92374, United States
BioMark Research Inc.
Whittier, California, 90603, United States
Clinical Research of the Rockies
Lafayette, Colorado, 80026, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, 80229, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010, United States
Shands Endoscopy Center
Gainesville, Florida, 32608, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
Shands Medical Plaza
Gainesville, Florida, 32610, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of Miami Hospital and Clinic
Miami, Florida, 33136, United States
University of Miami Hospital
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, FL 33136, United States
Cirtus Ambulartory Surgery Center
Orlando, Florida, 32806, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Heartland Medical Research (Administrative Only)
Clive, Iowa, 50325, United States
Iowa Digestive Disease Center
Clive, Iowa, 50325, United States
Iowa Endoscopy Center (Colonoscopy Only)
Clive, Iowa, 50325, United States
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Massachusetts Worcester
Worcester, Massachusetts, 01655, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Surgical Centers of Michigan
Troy, Michigan, 48098, United States
Minneapolis Heart Institute, West Health Campus
Minneapolis, Minnesota, 55404, United States
Noran Neurology Clinic
Minneapolis, Minnesota, 55407, United States
Consulting Radiology (Xray testing only)
Plymouth, Minnesota, 55446, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Surgery Center of Columbia
Columbia, Missouri, 65201, United States
Audrain Medical Center
Mexico, Missouri, 65265, United States
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, 65265, United States
Barnes-Jewish Hospital - Investigational Drug Services
St Louis, Missouri, 63110, United States
Center for Advanced Medicine
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Albany Medical College
Albany, New York, 12208, United States
Life Medi-Research And Management
Brooklyn, New York, 11206, United States
New York Hospital Queens
Flushing, New York, 11355, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021, United States
Nassau Gastroenterology Associates Office Based Surgery
Great Neck, New York, 11021, United States
Nassau Gastroenterology Associates, P.C.
Great Neck, New York, 11021, United States
North Shore Primary Care, P.C.
Great Neck, New York, 11021, United States
Beth Israel Medical Center - Phillip Ambulatory Care Center
New York, New York, 10003, United States
East side Endoscopy, LLC (for colonscopy testing only)
New York, New York, 10010, United States
Lenox Hill Endoscopy Center
New York, New York, 10075, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
CTRC Hospital - UNC Memorial Hospital
Chapel Hill, North Carolina, 27514, United States
North Carolina Memorial Hospital Endoscopy Center
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals Department of Pharmacy
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals Endoscopy
Chapel Hill, North Carolina, 27517, United States
Hillsborough Campus
Hillsborough, North Carolina, 27278, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
The Offices of Dr. Vincent Armenio, M.D.
East Providence, Rhode Island, 02914, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Bayside Endoscopy Center
Providence, Rhode Island, 02905, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center
Pasadena, Texas, 77505, United States
University of Utah HSC
Salt Lake City, Utah, 84132, United States
Charlottesville Gastroenterology Associates
Charlottesville, Virginia, 22902, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226, United States
GI Associates
Wauwatosa, Wisconsin, 53226, United States
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, 1090, Austria
UZ Gasthuisberg
Leuven, B-3000, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique
Liège, 4000, Belgium
Centre Hospitalier de Mouscron
Mouscron, 7700, Belgium
4-MHAT
Sofia, 1000, Bulgaria
MBAL Sofiamed OOD,Otdelenie po gastroenterologia
Sofia, 1979, Bulgaria
Vancouver Coastal Health - Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver Coastal Health - Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Oshawa Clinic
Oshawa, Ontario, L1H 1B9, Canada
Toronto Digestive Disease Associates Inc.
Vaughan, Ontario, L4L 4Y7, Canada
CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie
Amiens, 80054, France
Hopital Saint-Andre
Bordeaux, 33075, France
Hopital Beaujon- Essais cliniques
Clichy, 92110, France
Hopital de l'Archet 2 - CHU de Nice
Nice, 06202, France
Hopital Cochin-Essais Cliniques
Paris, 75014, France
Hopital Charles Nicolle
Rouen, 76031, France
Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Hopital Rangueil
Toulouse, 31059, France
Charite - Campus Berlin Mitte Medizinische Klinik
Berlin, 10117, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie
Lübeck, 23538, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Universitaetsklinikum Regensburg
Regensburg, 93042, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Universitaetklinikum Ulm
Ulm, 89081, Germany
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, 036-8545, Japan
National Hospital Organization Takasaki General Medical Center
Takasaki, Gunma, 370-0829, Japan
Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Aichi Medical University Hospital
Aichi, 480-1195, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Yokohama City University Medical Center
Kanagawa, 232-0024, Japan
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
University Medical Center Groningen (UMCG)
Groningen, Provincie Groningen, 9713GZ, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Asker And Baerum Hospital
Gjettum, 1346, Norway
Oslo Universitetssykehus
Oslo, 0424, Norway
Lovisenberg Diakonale Sykehus
Oslo, 0440, Norway
Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej
Bydgoszcz, 85-168, Poland
Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.
Lodz, 90-302, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie
Warsaw, 02-507, Poland
Lexmedica
Wroclaw, 53-114, Poland
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Hospital Centre Bezanijska Kosa
Belgrade, 11080, Serbia
Clinical Center Nis Clinic for Gastroenterology and Hepatology
Niš, 18000, Serbia
Clinical Hospital Center Zemun
Zemun, 11080, Serbia
Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
Bratislava, 831 04, Slovakia
Medak s.r.o.
Bratislava, 851 01, Slovakia
Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.
Nitra, 949 01, Slovakia
Synergy group, a.s.
Nové Mesto nad Váhom, 915 01, Slovakia
Wits Clinical Research
Johannesburg, Gauteng, 2193, South Africa
Parklands Medical Centre
Durban, KwaZulu-Natal, 4091, South Africa
Kingsbury Hospital
Cape Town, Western Cape, 7708, South Africa
Pusan National University Hospital
Busan, 602-739, South Korea
Yeungnam University Hospital
Daegu, 705-717, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Kangbuk Samsung Hospital
Seoul, 110-746, South Korea
Yonsei University College of Medicine, Severance Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitari Bellvitge
Barcelona, 08907, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Corporacio Sanitaria Parc Tauli de Sabadell
Sabadell, 08208, Spain
Related Publications (3)
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.
PMID: 32013314DERIVEDSandborn 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.
PMID: 28982740DERIVEDHassan-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.
PMID: 28961803DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2011
First Posted
January 13, 2011
Study Start
April 6, 2011
Primary Completion
February 7, 2014
Study Completion
October 9, 2015
Last Updated
June 3, 2021
Results First Posted
April 13, 2017
Record last verified: 2021-05