Ulcerative Colitis Clinical Trial
— OCTAVEOfficial title:
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
| Verified date | August 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
| Status | Completed |
| Enrollment | 547 |
| Est. completion date | June 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subject must be at least 18 years of age. - Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study. - Subjects with moderately to severely active UC based on Mayo score criteria. - Subjects must have failed or be intolerant of at least one of the following treatments for UC: - Corticosteroids (oral or intravenous). - Azathioprine or 6 mercaptopurine (6 MP). - Anti TNF therapy. Exclusion Criteria: - Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease. - Subjects with disease limited to distal 15 cm. - Subjects without previous treatment for UC (ie, treatment naïve). - Subjects displaying clinical signs of fulminant colitis or toxic megacolon. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Monash Medical Centre | Clayton | Victoria |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | The Canberra Hospital | Garran | Australian Capital Territory |
| Australia | Liverpool Hospital Eastern Campus | Liverpool | New South Wales |
| Austria | Medizinische Universitat Innsbruck | Innsbruck | |
| Austria | Krankenhaus Barmherzige Brueder St. Veit/Glan | St. Veit an der Glan | |
| Belgium | GZA St Vincentius | Antwerpen | |
| Belgium | AZ Groeninge, Campus Kennedylaan | Kortrijk | |
| Belgium | H-Hartziekenhuis Roeselare-Menen vzw | Roeselare | |
| Brazil | Hospital de Clinicas de Porto Alegre - HCPA | Porto Alegre | Rio Grande do Sul |
| Canada | University of Alberta - Zeidler Ledcor Centre | Edmonton | Alberta |
| Canada | University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre | Edmonton | Alberta |
| Canada | Montreal General Hospital - McGill University Health Centre | Montreal | Quebec |
| Canada | Royal University Hospital | Saskatoon | Saskatchewan |
| Canada | Saskatoon City Hospital | Saskatoon | Saskatchewan |
| Colombia | Instituto de Coloproctologia ICO S.A.S. | Medellin | Antioquia |
| Croatia | University Hospital Center Osijek, Clinic of Internal Medicine, | Osijek | |
| Croatia | University Hospital Rijeka | Rijeka | |
| Croatia | University Hospital Center Zagreb,Department of Gastroenterology | Zagreb | |
| Czech Republic | Nemocnice Strakonice, a.s., Interni oddeleni | Strakonice | |
| Czech Republic | Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z. | Usti nad Labem | |
| Denmark | Bispebjerg Hospital | Copenhagen | NV |
| Denmark | Hvidovre Hospital | Hvidovre | |
| Denmark | Odense University Hospital | Syddanmark | |
| Estonia | Mammograaf OU (Endoscopy Only) | Talinn | |
| Estonia | East Tallinn Central Hospital Internal Medicine Clinic | Tallinn | |
| Estonia | ECG Unit, East Tallinn Central Hospital | Tallinn | |
| Estonia | ECG Unit, Innomedica OU and Qualitas AS (ECG Only) | Tallinn | |
| Estonia | Innomedica OU | Tallinn | |
| Estonia | Quattromed HTI Laboratorid OU | Tallinn | |
| Estonia | X-Ray Unit, East Tallinn Central Hospital | Tallinn | |
| Estonia | X-Ray Unit, Qualitas AS (X-Ray Only) | Tallinn | |
| France | CHU Amiens PICARDIE - Hopital SUD | Amiens Cedex 1 | |
| France | Hopital Saint Andre | Bordeaux cedex | |
| France | Hopital Beaujon | Clichy Cedex | |
| France | Hopital Saint Antoine | Paris Cedex 12 | |
| France | C.H.U. de Reims - Hôpital Robert Debré | Reims cedex | |
| France | CHU de Reims - Pharmacie | Reims Cedex | |
| France | Hopital Nord | St Priest En Jarez | |
| Germany | Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | |
| Germany | Universitäetsklinik Schleswig-Holstein, Campus Kiel | Kiel | Schlewig Holstein |
| Germany | Gastroenterologische Gemeinschaftspraxis Minden | Minden | |
| Germany | University Hospital Munich-Grosshadern | Munich | |
| Germany | Universitaetsklinikum Ulm | Ulm | |
| Hungary | Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat | Bekescsaba | |
| Hungary | MH Honvedkorhaz | Budapest | |
| Hungary | Pannonia Maganorvosi Centrum Kft. | Budapest | |
| Hungary | Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat | Budapest | |
| Hungary | Szent Janos Korhaz és Eszak-budai Egyesített Korhazak | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék | Debrecen | |
| Hungary | Bekes Megyei Pandy Kalman Korhaz | Gyula | |
| Hungary | Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház | Miskolc | |
| Hungary | Karolina Korhaz Rendelointezet, Belgyogyaszat | Mosonmagyarovar | |
| Israel | Auckland City Hospital | Auckland | |
| Israel | The Edith Wolfson Medical Center/Gastroenterology Institute | Holon | |
| Israel | Kaplan Medical Center | Rehovot | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Kyung Hee University Hospital, Clinical Laboratory | Dongdaemun-gu | Seoul |
| Korea, Republic of | Hanyang University Guri Hospital, Clinical Laboratory | Guri-si | Gyunggi-do |
| Korea, Republic of | Gachon University Gil Hospital | Incheon | |
| Korea, Republic of | Pusan National University Hospital, Clinical Laboratory | Seo-Gu | Busan |
| Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Asan Medical Center, Clinical Laboratory | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Latvia | Daugavpils Regional Hospital | Daugavpils | |
| Latvia | Daugavpils Regional Hospital Microbiology and Clinical Laboratory | Daugavpils | |
| Netherlands | Academic Medical Centre (AMC), | Amsterdam | |
| Netherlands | VU University Medical Center (VUMC) | Amsterdam | |
| Netherlands | University Medical Center Groningen (UMCG) | Groningen | |
| New Zealand | Auckland City Hospital | Auckland | |
| New Zealand | Christchurch Hospital | Christchurch | Canterbury |
| New Zealand | Waikato Hospital | Hamilton | |
| New Zealand | Bowen Hospital | Wellington | |
| New Zealand | P3 Research Limited | Wellington | |
| New Zealand | Pacific Radiology (X-rays only) | Wellington | |
| Poland | Oddzial Chorob Wewnetrznych i Gastroenterologii, | Bialystok | |
| Poland | Centrum Endoskopii Zabiegowej | Bydgoszcz | Kujawsko-Pomorskie |
| Poland | Gabinet Endoskopii Przewodu Pokarmowego | Krakow | |
| Poland | Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. | Lodz | |
| Poland | Endoskopia SP. Z O.O. | Sopot | |
| Poland | H-T. Centrum Medyczne - ENDOTERAPIA | Tychy | Slaskie |
| Poland | Nzoz Vivamed | Warszawa | |
| Romania | Spitalul Universitar de Urgenta Bucuresti, Sectia De Medicina Intema II si Gastroenterologie | Bucuresti | Sector 5 |
| Romania | Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie | Targu Mures | Mures |
| Russian Federation | Federal state budget institution "State scientific centre of coloproctology" | Moscow | |
| Russian Federation | State budget Healthcare Institution Moscow regional scientific research clinical institute | Moscow | |
| Russian Federation | State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow" | Moscow | Russia |
| Russian Federation | FGBU "Scientific Research Institute of Physiology and Fundamental Medicine"Siberian Branch of RAMS | Novosibirsk | |
| Russian Federation | Municipal institution of healthcare "City clinical hospital 12" | Saratov | |
| Russian Federation | Municipal institution of healthcare "Clinical Hospital # 2" | Yaroslavl | Russia |
| Russian Federation | OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo" | Yaroslavl | Russia |
| Russian Federation | State Institution of healthcare Yaroslavl Regional Clinical Hospital | Yaroslavl | |
| Serbia | Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology | Belgrade | |
| Serbia | Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology | Novi Sad | |
| Serbia | Clinical Centre of Vojvodina, Emergency Internal Medicine Division | Novi Sad | |
| Serbia | General Hospital Subotica | Subotica | |
| Slovakia | Lama Medical Care s.r.o. | Bratislava | |
| Slovakia | KM Management spol. s r.o. | Nitra | |
| Slovakia | Poliklinika Libris, Synergy group, a.s. | Nove Mesto Nad Vahom | |
| Slovakia | Gastro I., s.r.o. | Presov | |
| South Africa | Panorama Medi-Clinic | Cape Town | Western Cape |
| South Africa | The Louis Leipoldt Medical Centre | Cape Town | Western Cape |
| South Africa | Dr JP Wright | Claremont, Cape Town | Western Cape |
| Spain | Hospital Universitario de Bellvitge | Barcelona | |
| Spain | Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona |
| Taiwan | Chung Shan Medical University Hospital | Taichung | |
| Taiwan | National Taiwan University Hospital | Taipei City | |
| Ukraine | Local laboratory of Regional Municipal Institution ¿Chernivtsi Regional Clinical Hospital¿ | Chernivtsi | |
| Ukraine | Regional Municipal Institution Chernivtsi Regional Clinical Hospital | Chernivtsi | |
| Ukraine | Regional Municipal Institution "Chernivtsi Regional Clinical Hospital" | Chernivtsi, | |
| Ukraine | State Institution Institute of Gastroenterology of the National Academy of Medical Sciences of Ukra | Dniepropetrovsk | |
| Ukraine | Municipal Healthcare Institution ¿Kharkiv City Clinical Hospital #2¿, Proctology Department | Kharkiv | |
| Ukraine | Kyiv City Clinical Hospital #8, | Kiev | |
| Ukraine | Department of clinical and laboratory diagnostic of Municipal Institution | Odesa | |
| Ukraine | Municipal Institution "Odesa Regional Clinical Hospital" | Odesa | |
| Ukraine | Medical Clinical Research Center "Health Clinic" on the base of | Vynnytsya | |
| Ukraine | Minicipal Institution 'City Hospital | Zaporizhzhia | |
| United Kingdom | University Hospitals Bristol NHS Foundation Trust | Bristol | |
| United Kingdom | St Mark's Hospital | Harrow | Middlesex |
| United Kingdom | Norfolk and Norwich University Hospital | Norwich | Norfolk |
| United States | Texas Clinical Research Institiute | Arlington | Texas |
| United States | Austin Gastroenterology PA | Austin | Texas |
| United States | Austin Gastroenterology PA/Professional Quality Research, Inc. | Austin | Texas |
| United States | Bristol Hospital | Bristol | Connecticut |
| United States | Connecticut Clinical Research Foundation | Bristol | Connecticut |
| United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
| United States | Chevy Chase Endoscopy Center (Endoscopies only) | Chevy Chase | Maryland |
| United States | Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research | Chevy Chase | Maryland |
| United States | Surgery Center of Columbia | Columbia | Missouri |
| United States | Citrus Surgery & Endoscopy Center (Colonoscopy) | Crystal River | Florida |
| United States | Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia |
| United States | AGA Clinical Research Associates, LLC | Egg Harbor Township | New Jersey |
| United States | Carolina Research - Carolina Digestive Diseases | Greenville | North Carolina |
| United States | Hannibal Regional Hospital | Hannibal | Missouri |
| United States | Memorial Hermann Hospital | Houston | Texas |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Nature Coast Clinical Research | Inverness | Florida |
| United States | Suncoast Endoscopy Center (colonoscopy) | Inverness | Florida |
| United States | Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | South Jersey Gastroenterology | Marlton | New Jersey |
| United States | Audrain Medical Center | Mexico | Missouri |
| United States | Center for Digestive & Liver Disease, Inc. | Mexico | Missouri |
| United States | Gastroenterology Group of Naples | Naples | Florida |
| United States | Vanderbilt University Medical Center - Drug Shipment | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center - GCRC | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center - GI Research Office | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center - Heart Station | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center - IBD Clinic | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center - Radiology | Nashville | Tennessee |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Alliance Clinical Research | Oceanside | California |
| United States | Central Connecticut Endoscopy Center | Plainville | Connecticut |
| United States | Advanced Gastroenterology Center | Port Orange | Florida |
| United States | Advanced Medical Research Center | Port Orange | Florida |
| United States | Endoscopy Center | Port Orange | Florida |
| United States | Port Orange Urgent Care | Port Orange | Florida |
| United States | VCU Health System Digestive Health Center | Richmond | Virginia |
| United States | VCU Health System Endoscopy Suite | Richmond | Virginia |
| United States | VCU Medical Center Investigational Drug Service (IDS) | Richmond | Virginia |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester | Rochester | New York |
| United States | Clinical Application Laboratories | San Diego | California |
| United States | San Diego Endoscopy Center | San Diego | California |
| United States | Medical Center at Mount Zion | San Francisco | California |
| United States | UCSF Endoscopy Unit at Mount Zion | San Francisco | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | Gastrointestinal Specialists, A.M.C. | Shreveport | Louisiana |
| United States | Louisiana Research Center, LLC | Shreveport | Louisiana |
| United States | Shreveport Endoscopy Center, A.M.C. | Shreveport | Louisiana |
| United States | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas |
| United States | Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California |
| United States | Center for Digestive Health | Troy | Michigan |
| United States | Surgical Centers of Michigan | Troy | Michigan |
| United States | Desert Sun Clinical Research, LCC | Tucson | Arizona |
| United States | Desert Sun Gastroenterology | Tucson | Arizona |
| United States | Desert Sun Surgery Center | Tucson | Arizona |
| United States | Digestive Health Specialists of Tyler | Tyler | Texas |
| United States | The Gastroenterology Group of South Jersey | Vineland | New Jersey |
| United States | The Endo Center at Voorhees | Voorhees | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of subjects in remission at Week 8. | 8 weeks | No | |
| Secondary | The proportion of subjects achieving mucosal healing at Week 8. | 8 weeks | No | |
| Secondary | The proportion of subjects achieving clinical response at Week 8. | 8 weeks | No | |
| Secondary | The proportion of subjects in clinical remission at Week 8. | 8 weeks | No | |
| Secondary | The proportion of subjects in symptomatic remission at Week 8. | 8 weeks | No | |
| Secondary | The proportion of subjects achieving deep remission at Week 8. | 8 weeks | No | |
| Secondary | Partial Mayo scores and change from baseline over time. | 8 weeks | No | |
| Secondary | Change from baseline at Week 8 in total Mayo score. | 8 weeks | No |
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