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Long-Term Safety Of PF-00547659 In Ulcerative Colitis (TURANDOT II)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
75mg SHP647 (PF-00547659)
225mg SHP647 (PF-00547659)
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Anti-TNF Refractory, Active Ulcerative Colitis, Immunosuppressant Refractory

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects between 18 and 66 years of age.
  • Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of study A7281009 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 preclude entry or participation in this study.
  • Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).

Sites / Locations

  • Mayo Clinic Arizona - Scottsdale
  • UCSD Altman Clinical and Translational Research Institute
  • Community Clinical Trials
  • Rocky Mountain Gastroenterology
  • Medical Research Center of Connecticut, LLC
  • Nature Coast Clinical Research
  • Bassan and Bloom M.D.s
  • Internal Medicine Specialists
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology Specialists, PC
  • University of Kentucky Medical Center
  • Commonwealth Clinical Studies
  • University of Michigan
  • Minnesota Gastroenterology, PA
  • Center for Digestive and Liver Diseases
  • Washington University School of Medicine
  • University of Nevada School of Medicine
  • Dartmouth Hitchcock Medical Center
  • Albany Medical College
  • Weill Cornell Medical College of Cornell University
  • Premier Medical Group of the Hudson Valley, PC
  • UNC Memorial Hospital
  • The Oregon Clinic-West Hills Gastroenterology Associates, P.C.
  • Gastro One
  • Vanderbilt University Medical Center
  • Baylor College Of Medicine - Baylor Medical Center
  • McGuire DVAMC
  • Univeristy of Washington
  • Allegiance Research Specialists
  • The Canberra Hospital
  • Concord Repatriation General Hospital
  • Royal Brisbane and Women's Hospital
  • Mater Health Services
  • Alfred Hospital
  • The Royal Melbourne Hospital
  • AKH Wien, Universitaetsklinik fuer Innere Medizin III
  • AZ St. Elisabeth Herentals
  • University Hospital Gasthuisberg
  • Centre Hospitalier de Mouscron
  • MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
  • (G.I.R.I.) GI Research Institute
  • Percuro Clinical Research, Ltd
  • Hamilton Health Sciences Corp, McMaster Univ Medical Centre
  • London Health Sciences Centre - University Hospital
  • Taunton Surgical Centre
  • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
  • Royal University Hospital
  • Hepato-Gastroenterologie HK s.r.o. Poliklinika III
  • IBD Clinical and Research Centre
  • Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem
  • CHU Amiens-Picardie - Hopital Sud
  • Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
  • Hopital Huriez CHRU de Lille
  • CHU De Nice Hopital De L'Archet II
  • CHU de Saint-Etienne Hopital Nord
  • CHU de Nancy - Hopital Brabois
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1
  • Csongrad Megyei Dr. Bugyi Istvan Korhaz
  • Shaare Zedek Medical Center
  • Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit
  • Meir Medical Center
  • The Chaim Sheba Medical Center
  • Universita' degli Studi "Magna Graecia" di Catanzaro
  • Milan University, Humanitas Clinical Institute
  • Policlinico Universitario Campus Bio-Medico
  • Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
  • Azienda Ospedaliera San Camillo Forlanini
  • Universita Cattolica del Sacro Cuore
  • Ospedale Casa Sollievo della Sofferenza
  • Yeungnam University Medical Center
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Academic Medical Center
  • University Medical Center Groningen (UMCG)
  • Maastricht University Medical Center
  • Christchurch Hospital
  • Waikato Hospital
  • Centrum Endoskopii Zabiegowej
  • Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.
  • Gabinet Endoskopii Przewodu Pokarmowego
  • NZOZ Centrum Medyczne HCP sp. z o.o
  • Klinika Chorob Wewnetrznych I Gastroenterologii
  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
  • Lexmedica
  • St. Petersburg State Medical Academy for Postgraduate Education
  • Military Medical Academy
  • Clinical Hospital Center Zemun
  • Clinical Hospital Centre Bezanijska Kosa
  • Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica
  • Gastro L., s.r.o.
  • Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica
  • Kingsbury Hospital
  • Hospital Universitario Puerta de Hierro
  • Centro Medico Teknon-Institut de la Macula i de la Retina
  • Hospital Clinic de Barcelona
  • Parc de Salut Mar-Hospital del Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SHP647 75 mg

SHP647 225 mg

Arm Description

Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.

Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.

Secondary Outcome Measures

Percentage of Participants With Mucosal Healing at Week 16
Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Serum Trough Concentrations of SHP647 Versus Time
Serum trough concentrations of SHP647 versus time was reported.
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64. The number of participants with positive ADA was reported.
Number of Participants With Positive Neutralizing Antibodies (NAb)
The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64.

Full Information

First Posted
January 8, 2013
Last Updated
May 11, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01771809
Brief Title
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Acronym
TURANDOT II
Official Title
A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 18, 2013 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
December 13, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Anti-TNF Refractory, Active Ulcerative Colitis, Immunosuppressant Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHP647 75 mg
Arm Type
Experimental
Arm Description
Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Arm Title
SHP647 225 mg
Arm Type
Experimental
Arm Description
Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Intervention Type
Drug
Intervention Name(s)
75mg SHP647 (PF-00547659)
Intervention Description
75 mg sterile liquid injected subcutaneously every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
225mg SHP647 (PF-00547659)
Intervention Description
225 mg sterile liquid injected subcutaneously every 4 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
Time Frame
From start of study drug administration up to 168 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Mucosal Healing at Week 16
Description
Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Time Frame
Week 16
Title
Serum Trough Concentrations of SHP647 Versus Time
Description
Serum trough concentrations of SHP647 versus time was reported.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Title
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Description
The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64. The number of participants with positive ADA was reported.
Time Frame
Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Title
Number of Participants With Positive Neutralizing Antibodies (NAb)
Description
The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64.
Time Frame
Baseline, Week 8, 16, 24, 40, 48, 64 and 156

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects between 18 and 66 years of age. Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period. Exclusion Criteria: Subjects that have completed Day 84 (Week 12) of study A7281009 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 preclude entry or participation in this study. Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shire Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UCSD Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rocky Mountain Gastroenterology
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
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
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Bassan and Bloom M.D.s
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Specialists, PC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Commonwealth Clinical Studies
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minnesota Gastroenterology, PA
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Center for Digestive and Liver Diseases
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nevada School of Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
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
Premier Medical Group of the Hudson Valley, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
UNC Memorial Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Oregon Clinic-West Hills Gastroenterology Associates, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
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
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Baylor College Of Medicine - Baylor Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Univeristy of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
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
Herston
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
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
AKH Wien, Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ St. Elisabeth Herentals
City
Herentals
ZIP/Postal Code
2200
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Facility Name
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Percuro Clinical Research, Ltd
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Hamilton Health Sciences Corp, McMaster Univ Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Taunton Surgical Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Hepato-Gastroenterologie HK s.r.o. Poliklinika III
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
IBD Clinical and Research Centre
City
Prague
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
CHU Amiens-Picardie - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Huriez CHRU de Lille
City
Lille
ZIP/Postal Code
59037 Cedex
Country
France
Facility Name
CHU De Nice Hopital De L'Archet II
City
Nice Cedex 03
ZIP/Postal Code
06200
Country
France
Facility Name
CHU de Saint-Etienne Hopital Nord
City
Saint Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
CHU de Nancy - Hopital Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
State/Province
Csongrad
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Universita' degli Studi "Magna Graecia" di Catanzaro
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Milan University, Humanitas Clinical Institute
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Centrum Endoskopii Zabiegowej
City
Bydgoszcz
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.
City
Lodz
State/Province
Wojlodzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Gabinet Endoskopii Przewodu Pokarmowego
City
Krakow
ZIP/Postal Code
31-009
Country
Poland
Facility Name
NZOZ Centrum Medyczne HCP sp. z o.o
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Klinika Chorob Wewnetrznych I Gastroenterologii
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
St. Petersburg State Medical Academy for Postgraduate Education
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Hospital Centre Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Gastro L., s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica
City
Ruzomberok
ZIP/Postal Code
034 26
Country
Slovakia
Facility Name
Kingsbury Hospital
City
Claremont
State/Province
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Centro Medico Teknon-Institut de la Macula i de la Retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Parc de Salut Mar-Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7281010&StudyName=Long-Term%20Safety%20Of%20PF-00547659%20In%20Ulcerative%20Colitis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Long-Term Safety Of PF-00547659 In Ulcerative Colitis

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