Clinical trial NCT01298492: A Study To Monitor Long-Term Treatment With PF-00547659
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Active Crohn's disease
Anti-TNF Refractory
Immunosuppressant Refractory
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
timeFrame: From start of study treatment up to Week 72 (Treatment Period)
Secondary outcomes:
measure: Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
timeFrame: Baseline up to Week 96
measure: Serum Trough Concentrations of PF-00547659 Versus Time
timeFrame: 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
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center - Thorton Hospital
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Orange
country: United States
facility: GastroDiagnostics
state: California
city: Lafayette
country: United States
facility: Clinical Research of the Rockies
state: Colorado
city: Thornton
country: United States
facility: Rmga - Rmcr
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Washington
country: United States
facility: MGG Group Co., Inc.
state: District of Columbia
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinic (IP Shipment Only)
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Orlando
country: United States
facility: Citrus Ambulatory Surgery Center
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Clive
country: United States
facility: Heartland Medical Research, Inc.
state: Iowa
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Clive
country: United States
facility: Iowa Endoscopy Center (Colonoscopy Only)
state: Iowa
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Worcester
state: Massachusetts
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Troy
country: United States
facility: Surgical Centers of Michigan
state: Michigan
city: Columbia
country: United States
facility: Surgery Center of Columbia
state: Missouri
city: Mexico
country: United States
facility: Audrain Medical Center
state: Missouri
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital - Investigational Drug Services
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Flushing
country: United States
facility: New York Hospital Queens
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Great Neck
country: United States
facility: Nassau Gastroenterology Associates Office Based Surgery
state: New York
city: Great Neck
country: United States
facility: Nassau Gastroenterology Associates, P.C.
state: New York
city: Great Neck
country: United States
facility: North Shore Primary Care, P.C.
state: New York
city: New York
country: United States
facility: Lenox Hill Endoscopy Center
state: New York
city: New York
country: United States
facility: Synergy First
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Chapel Hill
country: United States
facility: CTRC Hospital, UNC Memorial Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: North Carolina Memorial Hospital Endoscopy Center
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals Endoscopy
state: North Carolina
city: Hillsborough
country: United States
facility: Hillsborough Campus
state: North Carolina
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Wien
country: Austria
facility: AKH Wien Universitaetsklinik fuer Innere Medizin III
city: Wien
country: Austria
facility: AKH Wien
city: Brussels
country: Belgium
facility: Hospital Erasme
city: Leuven
country: Belgium
facility: UZ Gasthuisberg - Pharmacy
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman
city: Mouscron
country: Belgium
facility: Centre Hospitalier de Mouscron
city: Oshawa
country: Canada
facility: Oshawa Clinic
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc.
state: Ontario
city: Clichy
country: France
facility: Hopital Beaujon
city: Lille Cedex
country: France
facility: Hopital Huriez, CHRU de Lille
city: Lille
country: France
facility: CHRU de Lille, Pharamcie Centrale
city: Lille
country: France
facility: CIC - Hopital Cardiologique
city: NICE Cedex 3
country: France
facility: Hopital de l'Archet 2 - CHU de Nice
city: Paris
country: France
facility: Hopital Saint-Louis
city: St Priest En Jarez
country: France
facility: Hopital Nord
city: Toulouse Cedex 9
country: France
facility: Hopital Rangueil
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus GmbH
state: Baden-wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-wuerttemberg
city: Berlin
country: Germany
facility: "Charite - Campus Berlin Mitte Medizinische Klinik
city: Berlin
country: Germany
facility: Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Luebeck
country: Germany
facility: Universitaetsfrauenklinikum Schleswig-Holstein
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Regensburg
country: Germany
facility: Universitaetsklinik Regensburg
city: Takasaki
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
state: Gunma
city: Yokohama-Shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Aomori
country: Japan
facility: National Hospital Organization Hirosaki National Hospital
state: Toyko
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Gjettum
country: Norway
facility: Sykehusapoteket Asker og Baerum
city: Oslo
country: Norway
facility: Oslo Universitetssykehus
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Sykehus
city: Rud
country: Norway
facility: Vestre Viken HF
city: Bydgoszcz
country: Poland
facility: Centrum Endoskopii Zabiegowej
city: Lodz
country: Poland
facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie
city: Wroclaw
country: Poland
facility: Lexmedica
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Bezanijska Kosa
city: Zemun
country: Serbia
facility: Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology
city: Bratislava
country: Slovakia
facility: Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
city: Bratislava
country: Slovakia
facility: Medak s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Nove Mesto nad Vahom
country: Slovakia
facility: Synergy group, a.s.
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng, South Africa
city: Durban
country: South Africa
facility: Parklands Medical Centre
state: KWA ZULU Natal
city: Cape Town
country: South Africa
facility: Kingsbury Hospital
state: Western CAPE
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli de Sabadell
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli de Sabadell
state: Cataluna
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.