Clinical trial NCT01771809: Long-Term Safety Of PF-00547659 In Ulcerative Colitis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Anti-TNF Refractory
Active Ulcerative Colitis
Immunosuppressant Refractory
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 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)
timeFrame: From start of study drug administration up to 168 weeks
Secondary outcomes:
measure: Percentage of Participants With Mucosal Healing at Week 16
timeFrame: Week 16
measure: Serum Trough Concentrations of SHP647 Versus Time
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
measure: Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
timeFrame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156
measure: Number of Participants With Positive Neutralizing Antibodies (NAb)
timeFrame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona - Scottsdale
state: Arizona
city: La Jolla
country: United States
facility: UCSD Altman Clinical and Translational Research Institute
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Thornton
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Miramar
country: United States
facility: Bassan and Bloom M.D.s
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, PA
state: Minnesota
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College of Cornell University
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Chapel Hill
country: United States
facility: UNC Memorial Hospital
state: North Carolina
city: Portland
country: United States
facility: The Oregon Clinic-West Hills Gastroenterology Associates, P.C.
state: Oregon
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College Of Medicine - Baylor Medical Center
state: Texas
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Seattle
country: United States
facility: Univeristy of Washington
state: Washington
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Wien
country: Austria
facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III
city: Herentals
country: Belgium
facility: AZ St. Elisabeth Herentals
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Mouscron
country: Belgium
facility: Centre Hospitalier de Mouscron
city: Sofia
country: Bulgaria
facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corp, McMaster Univ Medical Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Surgical Centre
state: Ontario
city: Montreal
country: Canada
facility: Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK s.r.o. Poliklinika III
city: Prague
country: Czechia
facility: IBD Clinical and Research Centre
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem
city: Amiens
country: France
facility: CHU Amiens-Picardie - Hopital Sud
city: Caen
country: France
facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
city: Lille
country: France
facility: Hopital Huriez CHRU de Lille
city: Nice Cedex 03
country: France
facility: CHU De Nice Hopital De L'Archet II
city: Saint Priest En Jarez
country: France
facility: CHU de Saint-Etienne Hopital Nord
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy - Hopital Brabois
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz
state: Csongrad
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Catanzaro
country: Italy
facility: Universita' degli Studi "Magna Graecia" di Catanzaro
city: Milano
country: Italy
facility: Milan University, Humanitas Clinical Institute
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bydgoszcz
country: Poland
facility: Centrum Endoskopii Zabiegowej
state: Kujawsko-Pomorskie
city: Lodz
country: Poland
facility: Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.
state: Wojlodzkie
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Poznan
country: Poland
facility: NZOZ Centrum Medyczne HCP sp. z o.o
city: Warszawa
country: Poland
facility: Klinika Chorob Wewnetrznych I Gastroenterologii
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
city: Wroclaw
country: Poland
facility: Lexmedica
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Academy for Postgraduate Education
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Bezanijska Kosa
city: Nitra
country: Slovakia
facility: Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica
city: Presov
country: Slovakia
facility: Gastro L., s.r.o.
city: Ruzomberok
country: Slovakia
facility: Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica
city: Claremont
country: South Africa
facility: Kingsbury Hospital
state: Cape Town
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Centro Medico Teknon-Institut de la Macula i de la Retina
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Parc de Salut Mar-Hospital del Mar
Study officials:
affiliation: Takeda
name: Shire Director
role: STUDY_DIRECTOR
References: