Long-Term Safety Of PF-00547659 In Ulcerative Colitis
TURANDOT II
A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)
3 other identifiers
interventional
330
20 countries
98
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2013
Longer than P75 for phase_2
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedStudy Start
First participant enrolled
March 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2017
CompletedResults Posted
Study results publicly available
April 18, 2019
CompletedJune 3, 2021
May 1, 2021
4.7 years
January 8, 2013
December 11, 2018
May 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From start of study drug administration up to 168 weeks
Secondary Outcomes (4)
Percentage of Participants With Mucosal Healing at Week 16
Week 16
Serum Trough Concentrations of SHP647 Versus Time
Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Number of Participants With Positive Neutralizing Antibodies (NAb)
Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Study Arms (2)
SHP647 75 mg
EXPERIMENTALParticipants 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.
SHP647 225 mg
EXPERIMENTALParticipants 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.
Interventions
75 mg sterile liquid injected subcutaneously every 4 weeks.
225 mg sterile liquid injected subcutaneously every 4 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (99)
Mayo Clinic Arizona - Scottsdale
Scottsdale, Arizona, 85259, United States
UCSD Altman Clinical and Translational Research Institute
La Jolla, California, 92093, United States
Community Clinical Trials
Orange, California, 92868, United States
Rocky Mountain Gastroenterology
Thornton, Colorado, 80229, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Bassan and Bloom M.D.s
Miramar, Florida, 33025, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Minnesota Gastroenterology, PA
Plymouth, Minnesota, 55446, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, 65265, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nevada School of Medicine
Las Vegas, Nevada, 89102, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Albany Medical College
Albany, New York, 12208, United States
Weill Cornell Medical College of Cornell University
New York, New York, 10021, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601, United States
UNC Memorial Hospital
Chapel Hill, North Carolina, 27599, United States
The Oregon Clinic-West Hills Gastroenterology Associates, P.C.
Portland, Oregon, 97225, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Baylor College Of Medicine - Baylor Medical Center
Houston, Texas, 77030, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
Univeristy of Washington
Seattle, Washington, 98195, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226, United States
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Mater Health Services
South Brisbane, Queensland, 4101, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3052, Australia
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Vienna, 1090, Austria
AZ St. Elisabeth Herentals
Herentals, 2200, Belgium
University Hospital Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier de Mouscron
Mouscron, 7700, Belgium
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
Sofia, 1431, Bulgaria
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Percuro Clinical Research, Ltd
Victoria, British Columbia, V8V 3P9, Canada
Hamilton Health Sciences Corp, McMaster Univ Medical Centre
Hamilton, Ontario, L8S 4K1, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
Taunton Surgical Centre
Oshawa, Ontario, L1H 7K4, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal, Quebec, H1T 2M4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Hepato-Gastroenterologie HK s.r.o. Poliklinika III
Hradec Králové, 50012, Czechia
IBD Clinical and Research Centre
Prague, 170 04, Czechia
Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, 401 13, Czechia
CHU Amiens-Picardie - Hopital Sud
Amiens, 80054, France
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
Caen, 14033, France
Hopital Huriez CHRU de Lille
Lille, 59037 Cedex, France
CHU De Nice Hopital De L'Archet II
Nice, 06200, France
CHU de Saint-Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270, France
CHU de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, 54511, France
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1
Regensburg, 93053, Germany
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, Csongrád megye, 6600, Hungary
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 5262000, Israel
Universita' degli Studi "Magna Graecia" di Catanzaro
Catanzaro, 88100, Italy
Milan University, Humanitas Clinical Institute
Milan, 20089, Italy
Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
Roma, 00133, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Universita Cattolica del Sacro Cuore
Roma, 00168, Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
University Medical Center Groningen (UMCG)
Groningen, 9713 GZ, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Christchurch Hospital
Christchurch, Canterbury, 8140, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Centrum Endoskopii Zabiegowej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.
Lodz, Wojlodzkie, 90-302, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
NZOZ Centrum Medyczne HCP sp. z o.o
Poznan, 61-485, Poland
Klinika Chorob Wewnetrznych I Gastroenterologii
Warsaw, 02-507, Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
Warsaw, 03-580, Poland
Lexmedica
Wroclaw, 53-114, Poland
St. Petersburg State Medical Academy for Postgraduate Education
Saint Petersburg, 191015, Russia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Hospital Center Zemun
Belgrade, 11080, Serbia
Clinical Hospital Centre Bezanijska Kosa
Belgrade, 11080, Serbia
Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica
Nitra, 949 01, Slovakia
Gastro L., s.r.o.
Prešov, 080 01, Slovakia
Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica
Ružomberok, 034 26, Slovakia
Kingsbury Hospital
Claremont, Cape Town, 7708, South Africa
Yeungnam University Medical Center
Daegu, 42415, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Centro Medico Teknon-Institut de la Macula i de la Retina
Barcelona, 08022, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Parc de Salut Mar-Hospital del Mar
Barcelona, 8003, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Shire Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2013
First Posted
January 18, 2013
Study Start
March 18, 2013
Primary Completion
December 13, 2017
Study Completion
December 13, 2017
Last Updated
June 3, 2021
Results First Posted
April 18, 2019
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.