B0151005 Open-Label Extension Study (ANDANTE II)

January 10, 2024 updated by: Pfizer

A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

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

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women'S Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Health Services
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health, Box Hill Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital
  • Belgium
      • Bruxelles, Belgium, 1000
        • CHU Saint-Pierre
      • Bruxelles, Belgium, 1000
        • Chu St Pierre
      • Leuven, Belgium, 3000
        • University Hospital Leuven, Campus Gasthuisberg
      • Roeselare, Belgium, 8800
        • H.-Hartziekenhuis Roeselare-Menen vzw
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80810-040
        • Hospital Nossa Senhora Das Gracas
      • Curitiba, PR, Brazil, 80810-040
        • Setor de Cardiologia do Hospital Nossa Senhora das Gracas
      • Curitiba, PR, Brazil, 80810-040
        • Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
        • Hospital Universitário Fraga Filho da UFRJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
        • Laboratório de Análises Clínicas do HUCFF/UFRJ
    • SP
      • São Paulo, SP, Brazil, 05651-901
        • Hospital Israelita Albert Einstein
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4Z6
        • Heritage Medical Research Clinic - University Of Calgary
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Science Centre - University Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Centre
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. Poliklinika III
      • Olomouc, Czechia, 775 20
        • Fakultni Nemocnice Olomouc
      • Praha 10, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 4, Czechia, 140 21
        • Institut Klinicke a Experimentalni Mediciny
      • Usti nad Labem, Czechia, 40113
        • Krajska Zdravotni, a.s.
  • Denmark
      • Aarhus C, Denmark, 8000
        • Aarhus Universitetshospital, Aarhus Sygehus
      • Herlev, Denmark, 2730
        • "Gastroenheden Herlev Hospital
      • Hilleroed, Denmark, 3400
        • "Kirurgisk Afdeling 0143 Hilleroed Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Koebenhavn, Denmark, 2100
        • Rigshospitalet
      • Koebenhavn NV, Denmark, 2400
        • Bispebjerg Hospital
      • Koege, Denmark, 4600
        • Medicinsk Afdeling, Gastroenterologisk Sektion
  • France
      • Lille Cedex, France, 59037
        • Hopital Huriez CHRU de Lille
    • Cedex 12
      • Paris, Cedex 12, France, 75571
        • Hopital Saint-Antoine - Service De Gastroenterologie
  • Germany
      • Hamburg, Germany, 20148
        • Praxis Dr. Howaldt
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
  • Hungary
      • Budapest, Hungary, 1136
        • Pannonia Maganorvosi Centrum Kft.
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
      • Szekszard, Hungary, 7100
        • Clinfan Kft.
  • Ireland
      • Dublin, Ireland, D04 FX62
        • National Virus Reference Laboratory
      • Dublin, Ireland, D04 T6F4
        • Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group
      • Dublin, Ireland, D07 K201
        • Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
      • Dublin, Ireland, DUBLIN 4
        • St. Vincents University Hospital
      • Galway, Ireland
        • University Hospital Galway
  • Israel
      • Haifa, Israel, 3339419
        • Institute of Gastroenterology
      • Jerusalem, Israel, 91120
        • Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center, Beilinson Hospital
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
    • Jerusalem
      • Beith Vagan, Jerusalem, Israel, 91031
        • Digestive Disease Institute
  • Italy
      • Padova, Italy, 35128
        • Azienda Ospedaliera - Università di Padova
      • Roma, Italy, 00128
        • Universita Campus Biomedico UOC di Gastroenterologia
      • Rome, Italy, 00152
        • AOS San Camillo Forlanini
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas IRCCS
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
    • Auckland
      • Milford, Auckland, New Zealand, 0620
        • Shakespeare Specialist Group
  • Switzerland
      • Zuerich, Switzerland, 8091
        • Universitaetsspital Zuerich
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Glasgow, United Kingdom, G4 0SS
        • Glasgow Royal Infirmary
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust-Royal London Hospital
      • London, United Kingdom, E1 2AT
        • Clinical Research Centre
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital (Barts Health NHS Trust)
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Digestive Health Research Unit
      • Scottsdale, Arizona, United States, 85258
        • Simon Medical Imaging
      • Tucson, Arizona, United States, 85712
        • Adobe Clinical Research, LLC
      • Tucson, Arizona, United States, 85712
        • Adobe Surgery Center
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • Rocky Mountain Gastroenterology Associates
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Gastroenterology
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Clinical Research, LLC
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Clinical Research, LLC.
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Clearwater, Florida, United States, 33756
        • Gastroenterology Consultants of Clearwater
      • Crystal River, Florida, United States, 34429
        • Gastroenterology Associates
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Inverness, Florida, United States, 34453
        • Suncoast Endoscopy Center
      • Sanford, Florida, United States, 32771
        • International Clinical Research - US, LLC
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta Center For Gastroenterology, P.C.
      • Decatur, Georgia, United States, 30033
        • The Atlanta Center For Gastroenterology
      • Marietta, Georgia, United States, 30060
        • Gastointestinal Specialists of Georgia, PC
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Gastroenterology Group, LLC
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
      • Louisville, Kentucky, United States, 40202
        • U of L Health Care Outpatient Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Digestive Disorders Associates
      • Annapolis, Maryland, United States, 21401
        • Drgestive Disorders Associates
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • East Valley Endoscopy
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital Endoscopy Unit
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Weill Cornell Medical College of Cornell University
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
      • New York, New York, United States, 10028
        • Present, Chapman, Steinlauf and Marion
      • New York, New York, United States, 10065
        • Weill Cornell Imaging at New York Presbyterian Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medical College of Cornell University-Greenberg
      • New York, New York, United States, 10128
        • Arthur Asher Kombluth, MD PC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Oklahoma Foundation for Digestive Research
      • Oklahoma City, Oklahoma, United States, 73104
        • Colonoscopy and X-rays: OU Physicians Building
      • Oklahoma City, Oklahoma, United States, 73103
        • Pharmacy: Wheeler and Stuckey, Inc.
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
      • Tulsa, Oklahoma, United States, 74104
        • Hillcrest Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15243
        • Research Protocol Management Specialists
      • Pittsburgh, Pennsylvania, United States, 15241
        • Pittsburgh Gastroenterology Associates
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37212-1375
        • Vanderbilt University Medical Center: IBD Clinic
      • Nashville, Tennessee, United States, 37212-1610
        • Vanderbilt University Medical Center-GI Research
      • Nashville, Tennessee, United States, 37212
        • IBD Center-Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center-IDS
    • Texas
      • Austin, Texas, United States, 78705
        • Professional Quality Research, Inc.
      • Austin, Texas, United States, 78745
        • Austin Gastroenterology, PA
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77004
        • Diagnostic Clinic of Houston, PA
      • Houston, Texas, United States, 77004
        • Diagnostic Clinic Of Houston Pa
      • Houston, Texas, United States, 77030
        • The University of TX Health Sci. Ctr at Houston
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants
      • Tyler, Texas, United States, 75701
        • Digestive Health Specialists of Tyler
      • Tyler, Texas, United States, 75701
        • Clinical Pathologiy Laboratories, Inc, DBA DRL Labs
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23298
        • VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
  • Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label Treatment
Biological: PF-04236921
Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.
Biological: PF-04236921
Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Time Frame: Baseline up to Week 48
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
Baseline up to Week 48
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Time Frame: At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.
Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs.
At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

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

June 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimated)

May 2, 2011

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0151005
  • 2011-000722-30 (EudraCT Number)
  • ANDANTE II (Other Identifier: Alias Study 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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