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B0151005 Open-Label Extension Study (ANDANTE II)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04236921
PF-04236921
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, safety, efficacy, pharmacokinetics, pharmacodynamics, Crohn's Disease Activity Index (CDAI)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Simon Medical Imaging
  • Digestive Health Research Unit
  • Adobe Clinical Research, LLC
  • Adobe Surgery Center
  • Rocky Mountain Gastroenterology Associates
  • Rocky Mountain Gastroenterology
  • Rocky Mountain Clinical Research, LLC.
  • Rocky Mountain Clinical Research, LLC
  • Medical Research Center of Connecticut, LLC
  • Gastroenterology Consultants of Clearwater
  • Clinical Research of West Florida, Inc.
  • Gastroenterology Associates
  • Nature Coast Clinical Research
  • Suncoast Endoscopy Center
  • International Clinical Research - US, LLC
  • Atlanta Center for Gastroenterology, P.C.
  • The Atlanta Center For Gastroenterology
  • Gastointestinal Specialists of Georgia, PC
  • Illinois Gastroenterology Group, LLC
  • The University of Chicago Medical Center
  • NorthShore University Health System
  • University of Kentucky Chandler Medical Center
  • U of L Health Care Outpatient Center
  • University of Louisville Hospital
  • Digestive Disorders Associates
  • Drgestive Disorders Associates
  • East Valley Endoscopy
  • Gastroenterology Associates of Western Michigan
  • Metro Health Hospital Endoscopy Unit
  • Metro Health Hospital
  • Huron Gastroenterology Associates
  • Weill Cornell Medical College of Cornell University
  • Present, Chapman, Steinlauf and Marion
  • Mount Sinai School of Medicine
  • New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
  • Weill Cornell Imaging at New York Presbyterian Hospital
  • Weill Cornell Medical College of Cornell University-Greenberg
  • Arthur Asher Kombluth, MD PC
  • Oklahoma Foundation for Digestive Research
  • Colonoscopy and X-rays: OU Physicians Building
  • Pharmacy: Wheeler and Stuckey, Inc.
  • Hillcrest Medical Center
  • Options Health Research, LLC
  • Pittsburgh Gastroenterology Associates
  • Research Protocol Management Specialists
  • Gastro One
  • Vanderbilt University Medical Center: IBD Clinic
  • Vanderbilt University Medical Center-GI Research
  • IBD Center-Vanderbilt University Medical Center
  • Vanderbilt University Medical Center-IDS
  • Professional Quality Research, Inc.
  • Austin Gastroenterology, PA
  • Diagnostic Clinic Of Houston Pa
  • Diagnostic Clinic of Houston, PA
  • The University of Texas Health Science Center at Houston
  • The University of TX Health Sci. Ctr at Houston
  • Texas Digestive Disease Consultants
  • Clinical Pathologiy Laboratories, Inc, DBA DRL Labs
  • Digestive Health Specialists of Tyler
  • University of Utah Hospital
  • VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]
  • Virginia Commonwealth University
  • Concord Repatriation General Hospital
  • Royal Brisbane and Women's Hospital
  • Mater Health Services
  • Eastern Health, Box Hill Hospital
  • Monash Medical Centre
  • St. Vincent's Hospital
  • CHU Saint-Pierre
  • Chu St Pierre
  • University Hospital Leuven, Campus Gasthuisberg
  • H.-Hartziekenhuis Roeselare-Menen vzw
  • Hospital Nossa Senhora das Gracas
  • Setor de Cardiologia do Hospital Nossa Senhora das Gracas
  • Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas
  • Hospital Universitário Fraga Filho da UFRJ
  • Laboratório de Análises Clínicas do HUCFF/UFRJ
  • Hospital Israelita Albert Einstein
  • Heritage Medical Research Clinic - University of Calgary
  • London Health Science Centre - University Hospital
  • Mount Sinai Hospital
  • Montreal General Hospital - McGill University Health Centre
  • Hepato-Gastroenterologie HK, s.r.o. Poliklinika III
  • Fakultni nemocnice Olomouc
  • Fakultni Nemocnice Kralovske Vinohrady
  • Institut klinicke a experimentalni mediciny
  • Krajska zdravotni, a.s.
  • Aarhus Universitetshospital, Aarhus Sygehus
  • "Gastroenheden Herlev Hospital
  • "Kirurgisk Afdeling 0143 Hilleroed Hospital
  • Hvidovre Hospital
  • Bispebjerg Hospital
  • Rigshospitalet
  • Medicinsk Afdeling, Gastroenterologisk Sektion
  • Hopital Saint-Antoine - Service De Gastroenterologie
  • Hopital Huriez CHRU de Lille
  • Medizinische Hochschule Hannover
  • Praxis Dr. Howaldt
  • Universitaetsklinikum Schleswig-Holstein
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Pannonia Maganorvosi Centrum Kft.
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
  • Clinfan Kft.
  • National Virus Reference Laboratory
  • Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group
  • Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
  • St. Vincents University Hospital
  • University Hospital Galway
  • Digestive Disease Institute
  • Institute of Gastroenterology
  • Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)
  • Meir Medical Center
  • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Istituto Clinico Humanitas IRCCS
  • Azienda Ospedaliera - Universita di Padova
  • Universita Campus Biomedico UOC di Gastroenterologia
  • AOS San Camillo Forlanini
  • Shakespeare Specialist Group
  • Waikato Hospital
  • Universitaetsspital Zuerich
  • Addenbrookes Hospital
  • Glasgow Royal Infirmary
  • Barts Health NHS Trust-Royal London Hospital
  • Clinical Research Centre
  • St Bartholomew's Hospital (Barts Health NHS Trust)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label Treatment

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
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.
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2011
Last Updated
January 30, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01345318
Brief Title
B0151005 Open-Label Extension Study
Acronym
ANDANTE II
Official Title
A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, safety, efficacy, pharmacokinetics, pharmacodynamics, Crohn's Disease Activity Index (CDAI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label Treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PF-04236921
Intervention Description
Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.
Intervention Type
Biological
Intervention Name(s)
PF-04236921
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Description
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.
Time Frame
Baseline up to Week 48
Title
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Description
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.
Time Frame
At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
29247068
Citation
Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0151005&StudyName=B0151005%20Open-Label%20Extension%20Study
Description
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B0151005 Open-Label Extension Study

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