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

NCT ID: NCT01298492

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-01
• Study Completion Date: 2016-07-27

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Study Groups

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

Group Type: EXPERIMENTAL

PF-00547659

Intervention Type: DRUG

75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

UCSD Medical Center - Thorton Hospital

La Jolla, California, United States

Community Clinical Trials

Orange, California, United States

GastroDiagnostics

Orange, California, United States

Clinical Research of the Rockies

Lafayette, Colorado, United States

Rmga - Rmcr

Thornton, Colorado, United States

Rocky Mountain Gastroenterology Associates

Thornton, Colorado, United States

MGG Group Co., Inc.

Washington D.C., District of Columbia, United States

Florida Center for Gastroenterology

Largo, Florida, 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 and Clinic (IP Shipment Only)

Miami, Florida, United States

University of Miami Hospital and Clinic

Miami, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Citrus Ambulatory Surgery Center

Orlando, Florida, United States

Internal Medicine Specialists

Orlando, Florida, 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

Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Massachusetts Worcester

Worcester, Massachusetts, United States

Center for Digestive Health

Troy, Michigan, United States

Surgical Centers of Michigan

Troy, Michigan, United States

Surgery Center of Columbia

Columbia, Missouri, United States

Audrain Medical Center

Mexico, Missouri, United States

Center for Digestive and Liver Diseases, Inc.

Mexico, Missouri, United States

Barnes-Jewish Hospital - Investigational Drug Services

St Louis, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Center for Advanced Medicine

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Albany Medical College

Albany, New York, 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

Lenox Hill Endoscopy Center

New York, New York, United States

Synergy First

New York, New York, United States

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, 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

Hillsborough Campus

Hillsborough, North Carolina, United States

University of Washington Medical Center

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Allegiance Research Specialists

Wauwatosa, Wisconsin, United States

AKH Wien Universitaetsklinik fuer Innere Medizin III

Vienna, , Austria

AKH Wien

Vienna, , Austria

Hospital Erasme

Brussels, , Belgium

UZ Gasthuisberg - Pharmacy

Leuven, , Belgium

UZ Gasthuisberg

Leuven, , Belgium

Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman

Liège, , Belgium

Centre Hospitalier de Mouscron

Mouscron, , Belgium

Oshawa Clinic

Oshawa, Ontario, Canada

Toronto Digestive Disease Associates Inc.

Vaughan, Ontario, Canada

Hopital Beaujon

Clichy, , France

CHRU de Lille, Pharamcie Centrale

Lille, , France

CIC - Hopital Cardiologique

Lille, , France

Hopital Huriez, CHRU de Lille

Lille, , France

Hopital de l'Archet 2 - CHU de Nice

Nice, , France

Hopital Saint-Louis

Paris, , France

Hopital Nord

Saint-Priest-en-Jarez, , France

Hopital Rangueil

Toulouse, , France

Robert Bosch Krankenhaus GmbH

Stuttgart, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 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

Lübeck, , Germany

Gastroenterologische Gemeinschaftspraxis Minden

Minden, , Germany

Universitaetsklinik Regensburg

Regensburg, , Germany

National Hospital Organization Takasaki General Medical Center

Takasaki, Gunma, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

The Jikei University Hospital

Minato-Ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

National Hospital Organization Hirosaki National Hospital

Aomori, Toyko, Japan

Chiba University Hospital

Chiba, , Japan

Academic Medical Center

Amsterdam, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

Sykehusapoteket Asker og Baerum

Gjettum, Norway, Norway

Oslo Universitetssykehus

Oslo, , Norway

Lovisenberg Diakonale Sykehus

Oslo, , Norway

Vestre Viken HF

Rud, , Norway

Centrum Endoskopii Zabiegowej

Bydgoszcz, , Poland

NZOZ Centrum Medyczne Szpital Sw. Rodziny

Lodz, , Poland

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

Warsaw, , Poland

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie

Warsaw, , Poland

Lexmedica

Wroclaw, , Poland

Military Medical Academy

Belgrade, , Serbia

Clinical Hospital Centre Bezanijska Kosa

Belgrade, , Serbia

Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology

Zemun, , Serbia

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.

Nové Mesto nad Váhom, , Slovakia

Wits Clinical Research

Johannesburg, Gauteng, South Africa, South Africa

Parklands Medical Centre

Durban, KwaZulu-Natal, South Africa

Kingsbury Hospital

Cape Town, Western Cape, South Africa

Yeungnam University Hospital

Daegu, Korea, Republic of, South Korea

Pusan National University Hospital

Busan, , South Korea

Samsung Medical Center

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Corporacio Sanitaria Parc Tauli de Sabadell

Sabadell, Barcelona, Spain

Corporacio Sanitaria Parc Tauli de Sabadell

Sabadell, Catalonia, Spain

Hospital Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Countries

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

References

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.

Reference Type: DERIVED

PMID: 34427633 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7281007&StudyName=A%20Study%20To%20Monitor%20Long-Term%20Treatment%20With%20PF-00547659

To obtain contact information for a study center near you, click here.

Other Identifiers

2010-024638-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A7281007

Identifier Type: -

Identifier Source: org_study_id