We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

B0151005 Open-Label Extension Study (ANDANTE II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01345318
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: PF-04236921 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)
Study Start Date : June 2011
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345318


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01345318     History of Changes
Other Study ID Numbers: B0151005
2011-000722-30 ( EudraCT Number )
ANDANTE II ( Other Identifier: Alias Study Number )
First Posted: May 2, 2011    Key Record Dates
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: January 2017

Keywords provided by Pfizer:
Crohn's Disease
safety
efficacy
pharmacokinetics
pharmacodynamics
Crohn's Disease Activity Index (CDAI)

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases