Long-Term Safety Of PF-00547659 In Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771809
• Other study ID #: A7281010
• Secondary ID: 2012-002031-28TU
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2013
• Est. completion date: December 13, 2017

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• 75mg SHP647 (PF-00547659)
75 mg sterile liquid injected subcutaneously every 4 weeks.
• 225mg SHP647 (PF-00547659)
225 mg sterile liquid injected subcutaneously every 4 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 16
Secondary	Serum Trough Concentrations of SHP647 Versus Time	Serum trough concentrations of SHP647 versus time was reported.	Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Secondary	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.	Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Secondary	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.	Baseline, Week 8, 16, 24, 40, 48, 64 and 156

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