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NCT01298492 Clinical Trial

A Study To Monitor Long-Term Treatment With PF-00547659

Crohn's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01298492
Other study ID # A7281007
Secondary ID 2010-024638-48
Status Completed
Phase Phase 2
First received
Last updated
Start date July 1, 2011
Est. completion date July 27, 2016

Study information
Verified date May 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 268
Est. completion date July 27, 2016
Est. primary completion date July 27, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Austria AKH Wien Wien
Austria AKH Wien Universitaetsklinik fuer Innere Medizin III Wien
Belgium Hospital Erasme Brussels
Belgium UZ Gasthuisberg Leuven
Belgium UZ Gasthuisberg - Pharmacy Leuven
Belgium Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman Liege
Belgium Centre Hospitalier de Mouscron Mouscron
Canada Oshawa Clinic Oshawa Ontario
Canada Toronto Digestive Disease Associates Inc. Vaughan Ontario
France Hopital Beaujon Clichy
France CHRU de Lille, Pharamcie Centrale Lille
France CIC - Hopital Cardiologique Lille
France Hopital Huriez, CHRU de Lille Lille Cedex
France Hopital de l'Archet 2 - CHU de Nice NICE Cedex 3
France Hopital Saint-Louis Paris
France Hopital Nord St Priest En Jarez
France Hopital Rangueil Toulouse Cedex 9
Germany "Charite - Campus Berlin Mitte Medizinische Klinik Berlin
Germany Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum Berlin
Germany Krankenhaus Martha-Maria Halle-Doelau gGmbH Halle
Germany Universitaetsklinikum Schleswig-Holstein, Campus Kiel Kiel
Germany Universitaetsfrauenklinikum Schleswig-Holstein Luebeck
Germany Gastroenterologische Gemeinschaftspraxis Minden Minden
Germany Universitaetsklinik Regensburg Regensburg
Germany Robert Bosch Krankenhaus GmbH Stuttgart Baden-wuerttemberg
Germany Universitaetsklinikum Ulm Ulm Baden-wuerttemberg
Japan National Hospital Organization Hirosaki National Hospital Aomori Toyko
Japan Chiba University Hospital Chiba
Japan The Jikei University Hospital Minato-Ku Tokyo
Japan Keio University Hospital Shinjuku-Ku Tokyo
Japan National Hospital Organization Takasaki General Medical Center Takasaki Gunma
Japan Yokohama City University Medical Center Yokohama-Shi Kanagawa
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Netherlands Academic Medical Center Amsterdam
Netherlands University Medical Center Groningen Groningen
Netherlands Maastricht University Medical Center Maastricht
Norway Sykehusapoteket Asker og Baerum Gjettum
Norway Lovisenberg Diakonale Sykehus Oslo
Norway Oslo Universitetssykehus Oslo
Norway Vestre Viken HF Rud
Poland Centrum Endoskopii Zabiegowej Bydgoszcz
Poland NZOZ Centrum Medyczne Szpital Sw. Rodziny Lodz
Poland Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie Warszawa
Poland Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie Warszawa
Poland Lexmedica Wroclaw
Serbia Clinical Hospital Centre Bezanijska Kosa Belgrade
Serbia Military Medical Academy Belgrade
Serbia Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology Zemun
Slovakia Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o. Bratislava
Slovakia Medak s.r.o. Bratislava
Slovakia KM Management spol. s r.o. Nitra
Slovakia Synergy group, a.s. Nove Mesto nad Vahom
South Africa Kingsbury Hospital Cape Town Western CAPE
South Africa Parklands Medical Centre Durban KWA ZULU Natal
South Africa Wits Clinical Research Johannesburg Gauteng, South Africa
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Puerta de Hierro Majadahonda Majadahonda Madrid
Spain Corporacio Sanitaria Parc Tauli de Sabadell Sabadell Barcelona
Spain Corporacio Sanitaria Parc Tauli de Sabadell Sabadell Cataluna
United States Albany Medical College Albany New York
United States CTRC Hospital, UNC Memorial Hospital Chapel Hill North Carolina
United States North Carolina Memorial Hospital Endoscopy Center Chapel Hill North Carolina
United States UNC Hospitals Chapel Hill North Carolina
United States UNC Hospitals Endoscopy Chapel Hill North Carolina
United States Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research Chevy Chase Maryland
United States Heartland Medical Research, Inc. Clive Iowa
United States Iowa Digestive Disease Center Clive Iowa
United States Iowa Endoscopy Center (Colonoscopy Only) Clive Iowa
United States Surgery Center of Columbia Columbia Missouri
United States New York Hospital Queens Flushing New York
United States Long Island Clinical Research Associates, LLP Great Neck New York
United States Nassau Gastroenterology Associates Office Based Surgery Great Neck New York
United States Nassau Gastroenterology Associates, P.C. Great Neck New York
United States North Shore Primary Care, P.C. Great Neck New York
United States Hillsborough Campus Hillsborough North Carolina
United States UCSD Medical Center - Thorton Hospital La Jolla California
United States Clinical Research of the Rockies Lafayette Colorado
United States Florida Center for Gastroenterology Largo Florida
United States Audrain Medical Center Mexico Missouri
United States Center for Digestive and Liver Diseases, Inc. Mexico Missouri
United States Sylvester Comprehensive Cancer Center Miami Florida
United States University of Miami Crohn's and Colitis Center Miami Florida
United States University of Miami Hospital Miami Florida
United States University of Miami Hospital and Clinic Miami Florida
United States University of Miami Hospital and Clinic (IP Shipment Only) Miami Florida
United States Lenox Hill Endoscopy Center New York New York
United States Synergy First New York New York
United States Community Clinical Trials Orange California
United States GastroDiagnostics Orange California
United States Citrus Ambulatory Surgery Center Orlando Florida
United States Internal Medicine Specialists Orlando Florida
United States Premier Medical Group of the Hudson Valley, PC Poughkeepsie New York
United States Barnes-Jewish Hospital Saint Louis Missouri
United States Barnes-Jewish Hospital - Investigational Drug Services Saint Louis Missouri
United States Center for Advanced Medicine Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States University of Washington Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Rmga - Rmcr Thornton Colorado
United States Rocky Mountain Gastroenterology Associates Thornton Colorado
United States Center for Digestive Health Troy Michigan
United States Surgical Centers of Michigan Troy Michigan
United States MGG Group Co., Inc. Washington District of Columbia
United States Allegiance Research Specialists Wauwatosa Wisconsin
United States UMass Memorial Medical Center Worcester Massachusetts
United States University of Massachusetts Worcester Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Shire

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Serbia,  Slovakia,  South Africa,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. From start of study treatment up to Week 72 (Treatment Period)
Secondary 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. Baseline up to Week 96
Secondary Serum Trough Concentrations of PF-00547659 Versus Time 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
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