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

May 11, 2021 updated by: Shire

A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • AKH Wien
      • Wien, Austria, 1090
        • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • Belgium
      • Brussels, Belgium, B-1070
        • Hospital Erasme
      • Leuven, Belgium, B-3000
        • UZ Gasthuisberg
      • Leuven, Belgium, B-3000
        • UZ Gasthuisberg - Pharmacy
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman
      • Mouscron, Belgium, 7700
        • Centre Hospitalier de Mouscron
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates Inc.
  • France
      • Clichy, France, 92110
        • Hopital Beaujon
      • Lille, France, 59037
        • CHRU de Lille, Pharamcie Centrale
      • Lille, France, 59037
        • CIC - Hopital Cardiologique
      • Lille Cedex, France, 59037
        • Hopital Huriez, CHRU de Lille
      • NICE Cedex 3, France, 06202
        • Hopital de l'Archet 2 - CHU de Nice
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • St Priest En Jarez, France, 42270
        • Hôpital Nord
      • Toulouse Cedex 9, France, 31059
        • Hopital Rangueil
  • Germany
      • Berlin, Germany, 13353
        • Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
      • Berlin, Germany, 10117
        • "Charite - Campus Berlin Mitte Medizinische Klinik
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Doelau gGmbH
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
      • Luebeck, Germany, 23538
        • Universitaetsfrauenklinikum Schleswig-Holstein
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Regensburg, Germany, 93042
        • Universitaetsklinik Regensburg
    • Baden-wuerttemberg
      • Stuttgart, Baden-wuerttemberg, Germany, 70376
        • Robert Bosch Krankenhaus GmbH
      • Ulm, Baden-wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
    • Gunma
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center
    • Kanagawa
      • Yokohama-Shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
    • Tokyo
      • Minato-Ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
    • Toyko
      • Aomori, Toyko, Japan, 036-8545
        • National Hospital Organization Hirosaki National Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 705-717
        • Yeungnam University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 110-746
        • Kangbuk Samsung Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center
      • Groningen, Netherlands, 9713GZ
        • University Medical Center Groningen
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
  • Norway
      • Gjettum, Norway, 1346
        • Sykehusapoteket Asker og Baerum
      • Oslo, Norway, 0424
        • Oslo Universitetssykehus
      • Oslo, Norway, 0440
        • Lovisenberg Diakonale Sykehus
      • Rud, Norway, 1309
        • Vestre Viken HF
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Centrum Endoskopii Zabiegowej
      • Lodz, Poland, 90-302
        • NZOZ Centrum Medyczne Szpital Sw. Rodziny
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
      • Wroclaw, Poland, 53-114
        • LexMedica
  • Serbia
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11080
        • Clinical Hospital Centre Bezanijska Kosa
      • Zemun, Serbia, 11080
        • Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology
  • Slovakia
      • Bratislava, Slovakia, 831 04
        • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
      • Bratislava, Slovakia, 851 01
        • Medak s.r.o.
      • Nitra, Slovakia, 949 01
        • KM Management spol. s r.o.
      • Nove Mesto nad Vahom, Slovakia, 915 01
        • Synergy group, a.s.
  • South Africa
    • Gauteng, South Africa
      • Johannesburg, Gauteng, South Africa, South Africa, 2193
        • Wits Clinical Research
    • KWA ZULU Natal
      • Durban, KWA ZULU Natal, South Africa, 4091
        • Parklands Medical Centre
    • Western CAPE
      • Cape Town, Western CAPE, South Africa, 7708
        • Kingsbury Hospital
  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli de Sabadell
    • Cataluna
      • Sabadell, Cataluna, Spain, 08208
        • Corporacio Sanitaria Parc Tauli de Sabadell
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro Majadahonda
  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Medical Center - Thorton Hospital
      • Orange, California, United States, 92868
        • Community Clinical Trials
      • Orange, California, United States, 92868
        • GastroDiagnostics
    • Colorado
      • Lafayette, Colorado, United States, 80026
        • Clinical Research of the Rockies
      • Thornton, Colorado, United States, 80229
        • Rocky Mountain Gastroenterology Associates
      • Thornton, Colorado, United States, 80229
        • Rmga - Rmcr
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • MGG Group Co., Inc.
    • Florida
      • Largo, Florida, United States, 33777
        • Florida Center for Gastroenterology
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinic
      • Miami, Florida, United States, 33136
        • University of Miami Crohn's and Colitis Center
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinic (IP Shipment Only)
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, United States, 32806
        • Citrus Ambulatory Surgery Center
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center
      • Clive, Iowa, United States, 50325
        • Iowa Endoscopy Center (Colonoscopy Only)
      • Clive, Iowa, United States, 50325
        • Heartland Medical Research, Inc.
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Worcester
    • Michigan
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
      • Troy, Michigan, United States, 48098
        • Surgical Centers of Michigan
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Surgery Center of Columbia
      • Mexico, Missouri, United States, 65265
        • Audrain Medical Center
      • Mexico, Missouri, United States, 65265
        • Center for Digestive and Liver Diseases, Inc.
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, United States, 63110
        • Center for Advanced Medicine
      • Saint Louis, Missouri, United States, 63108
        • Barnes-Jewish Hospital - Investigational Drug Services
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Flushing, New York, United States, 11355
        • New York Hospital Queens
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
      • Great Neck, New York, United States, 11021
        • Nassau Gastroenterology Associates Office Based Surgery
      • Great Neck, New York, United States, 11021
        • Nassau Gastroenterology Associates, P.C.
      • Great Neck, New York, United States, 11021
        • North Shore Primary Care, P.C.
      • New York, New York, United States, 10075
        • Lenox Hill Endoscopy Center
      • New York, New York, United States, 11230
        • Synergy First
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley, PC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • North Carolina Memorial Hospital Endoscopy Center
      • Chapel Hill, North Carolina, United States, 27517
        • UNC Hospitals Endoscopy
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals
      • Chapel Hill, North Carolina, United States, 27514
        • CTRC Hospital, UNC Memorial Hospital
      • Hillsborough, North Carolina, United States, 27278
        • Hillsborough Campus
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label Treatment
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
Drug: PF-00547659
75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
Time Frame: From start of study treatment up to Week 72 (Treatment Period)
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.
From start of study treatment up to Week 72 (Treatment Period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
Time Frame: Baseline up to Week 96
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.
Baseline up to Week 96
Serum Trough Concentrations of PF-00547659 Versus Time
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
Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

July 27, 2016

Study Completion (Actual)

July 27, 2016

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7281007
  • 2010-024638-48 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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