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Crohn's DiseasePhase 2OPERA IINCT01298492

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

A Phase 2 study testing PF-00547659 in people with Crohn's Disease, run by Shire at 112 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
PF-00547659
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
112 sitesin 15 countries
Study dates
1 Jul 2011to 27 Jul 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

112 sites in 15 countries.

112 sites in 15 countries

United States47 sites

  • Albany Medical College

    Albany, New York, 12208

  • CTRC Hospital, UNC Memorial Hospital

    Chapel Hill, North Carolina, 27514

  • North Carolina Memorial Hospital Endoscopy Center

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals Endoscopy

    Chapel Hill, North Carolina, 27517

  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Heartland Medical Research, Inc.

    Clive, Iowa, 50325

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Iowa Endoscopy Center (Colonoscopy Only)

    Clive, Iowa, 50325

  • Surgery Center of Columbia

    Columbia, Missouri, 65201

  • New York Hospital Queens

    Flushing, New York, 11355

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • Nassau Gastroenterology Associates Office Based Surgery

    Great Neck, New York, 11021

  • Nassau Gastroenterology Associates, P.C.

    Great Neck, New York, 11021

  • North Shore Primary Care, P.C.

    Great Neck, New York, 11021

  • Hillsborough Campus

    Hillsborough, North Carolina, 27278

  • UCSD Medical Center - Thorton Hospital

    La Jolla, California, 92037

  • Clinical Research of the Rockies

    Lafayette, Colorado, 80026

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Audrain Medical Center

    Mexico, Missouri, 65265

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami Crohn's and Colitis Center

    Miami, Florida, 33136

  • University of Miami Hospital and Clinic (IP Shipment Only)

    Miami, Florida, 33136

  • University of Miami Hospital and Clinic

    Miami, Florida, 33136

  • University of Miami Hospital

    Miami, Florida, 33136

  • Lenox Hill Endoscopy Center

    New York, New York, 10075

  • Synergy First

    New York, New York, 11230

  • Community Clinical Trials

    Orange, California, 92868

  • GastroDiagnostics

    Orange, California, 92868

  • Citrus Ambulatory Surgery Center

    Orlando, Florida, 32806

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • University of Washington

    Seattle, Washington, 98195

  • Barnes-Jewish Hospital - Investigational Drug Services

    St Louis, Missouri, 63108

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Rmga - Rmcr

    Thornton, Colorado, 80229

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado, 80229

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Surgical Centers of Michigan

    Troy, Michigan, 48098

  • MGG Group Co., Inc.

    Washington D.C., District of Columbia, 20006

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • University of Massachusetts Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

Germany9 sites

  • "Charite - Campus Berlin Mitte Medizinische Klinik

    Berlin, 10117

  • Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum

    Berlin, 13353

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitaetsfrauenklinikum Schleswig-Holstein

    Lübeck, 23538

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Universitaetsklinik Regensburg

    Regensburg, 93042

  • Robert Bosch Krankenhaus GmbH

    Stuttgart, Baden-Wurttemberg, 70376

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

France8 sites

  • Hopital Beaujon

    Clichy, 92110

  • CHRU de Lille, Pharamcie Centrale

    Lille, 59037

  • CIC - Hopital Cardiologique

    Lille, 59037

  • Hopital Huriez, CHRU de Lille

    Lille, 59037

  • Hopital de l'Archet 2 - CHU de Nice

    Nice, 06202

  • Hopital Saint-Louis

    Paris, 75010

  • Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

Japan6 sites

  • National Hospital Organization Hirosaki National Hospital

    Aomori, Toyko, 036-8545

  • Chiba University Hospital

    Chiba, 260-8677

  • The Jikei University Hospital

    Minato-Ku, Tokyo, 105-8471

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

  • National Hospital Organization Takasaki General Medical Center

    Takasaki, Gunma, 370-0829

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

South Korea6 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Yeungnam University Hospital

    Daegu, Korea, Republic of, 705-717

  • Samsung Medical Center

    Seoul, 06351

  • Kangbuk Samsung Hospital

    Seoul, 110-746

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Belgium5 sites

  • Hospital Erasme

    Brussels, B-1070

  • UZ Gasthuisberg - Pharmacy

    Leuven, B-3000

  • UZ Gasthuisberg

    Leuven, B-3000

  • Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman

    Liège, 4000

  • Centre Hospitalier de Mouscron

    Mouscron, 7700

Other trials in Belgium

Poland5 sites

  • Centrum Endoskopii Zabiegowej

    Bydgoszcz, 85-168

  • NZOZ Centrum Medyczne Szpital Sw. Rodziny

    Lodz, 90-302

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

    Warsaw, 02-507

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie

    Warsaw, 02-507

  • Lexmedica

    Wroclaw, 53-114

Other trials in Poland

Spain5 sites

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Corporacio Sanitaria Parc Tauli de Sabadell

    Sabadell, Barcelona, 08208

  • Corporacio Sanitaria Parc Tauli de Sabadell

    Sabadell, Catalonia, 08208

Other trials in Spain

Norway4 sites

  • Sykehusapoteket Asker og Baerum

    Gjettum, Norway, 1346

  • Oslo Universitetssykehus

    Oslo, 0424

  • Lovisenberg Diakonale Sykehus

    Oslo, 0440

  • Vestre Viken HF

    Rud, 1309

Other trials in Norway

Slovakia4 sites

  • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

    Bratislava, 831 04

  • Medak s.r.o.

    Bratislava, 851 01

  • KM Management spol. s r.o.

    Nitra, 949 01

  • Synergy group, a.s.

    Nové Mesto nad Váhom, 915 01

Other trials in Slovakia

Netherlands3 sites

  • Academic Medical Center

    Amsterdam, 1105 AZ

  • University Medical Center Groningen

    Groningen, 9713GZ

  • Maastricht University Medical Center

    Maastricht, 6229 HX

Other trials in Netherlands

Serbia3 sites

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Centre Bezanijska Kosa

    Belgrade, 11080

  • Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology

    Zemun, 11080

Other trials in Serbia

South Africa3 sites

  • Kingsbury Hospital

    Cape Town, Western Cape, 7708

  • Parklands Medical Centre

    Durban, KwaZulu-Natal, 4091

  • Wits Clinical Research

    Johannesburg, Gauteng, South Africa, 2193

Other trials in South Africa

Austria2 sites

  • AKH Wien Universitaetsklinik fuer Innere Medizin III

    Vienna, 1090

  • AKH Wien

    Vienna, 1090

Other trials in Austria

Canada2 sites

  • Oshawa Clinic

    Oshawa, Ontario, L1H 1B9

  • Toronto Digestive Disease Associates Inc.

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

About this study

Official title: 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.

Read the 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
Being tested
PF-00547659
Keywords
Active Crohn's disease, Anti-TNF Refractory, Immunosuppressant Refractory
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-00547659Drug

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

Study groups in NCT01298492
Study groupRoleWhat they receive
Open-Label TreatmentExperimentalSubjects 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
Receives: Drug: PF-00547659

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From start of study treatment up to Week 72 (Treatment Period)

Secondary outcomes (2)

  1. 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.

    Measured: Baseline up to Week 96

  2. Serum Trough Concentrations of PF-00547659 Versus Time

    Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2011 (estimated)
  2. Study start1 Jul 2011
  3. Primary completion27 Jul 2016
  4. Study completion27 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01298492
Sponsor's protocol ID
A7281007
Other IDs
2010-024638-48
Acronym
OPERA II
Status last verified
May 2021
First submitted
26 Jan 2011
Last updated
3 Jun 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34427633

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-00547659 in people with Crohn's Disease, run by Shire at 112 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Germany, France, Japan, South Korea and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01298492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.

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