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 | 614 |
| Est. completion date | May 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-alpha 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 | Eastern Health | Box Hill | Victoria |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Nepean Hospital | Kingswood | New South Wales |
| Austria | AKH Wien, Universitaetsklinik fuer Innere Medizin III, | Wien | |
| Belgium | UZ Leuven (University Hospital Leuven), Campus Gasthuisberg | Leuven | |
| Canada | Hertiage Medical Research Clinic- University Of Calgary | Calgary | Alberta |
| Canada | HHSC, McMaster Hospital Site | Hamilton | Ontario |
| Canada | London Health Sciences Centre - University Hospital | London | Ontario |
| Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
| Colombia | Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A. | Barranquilla | Atlantico |
| Croatia | General Hospital Zadar | Zadar | |
| Czech Republic | Hepato-Gastroenterologie HK, s.r.o. | Hradec Kralove | |
| Czech Republic | Institut klinicke a experimentalni mediciny | Praha 4 | |
| Czech Republic | Klinicke Centrum ISCARE I.V.F. | Praha 7 | |
| Denmark | Aalborg Hospital | Aalborg | |
| Denmark | Aalborg Hospital Department of Medical Gastroenterology | Aalborg | |
| Denmark | Aarhus University Hospital | Aarhus C | |
| Estonia | West Tallinn Central Hospital Internal Diseases Clinic | Tallinn | |
| France | CHU de Nantes - Hotel Dieu | Nantes | |
| France | Hopital Saint-Louis | Paris | |
| France | Hopital Rangueil | Toulouse Cedex 9 | |
| Germany | Charite Campus Virchow-Klinikum Universitaetsmedizin Berlin Medizinische Klinik mit Schwerpunkt Gast | Berlin | |
| Germany | Universitaetsklinikum Halle (Saale) | Halle | |
| Germany | Medizinische Hochschule Hannover | Hannover | |
| Germany | Klinikum Luneburg/Abteilung Gastroenterologie | Lüneburg | |
| Hungary | Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly | Budapest | |
| Hungary | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs | |
| Hungary | Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika | Szeged | |
| Hungary | Javorszky Odon Korhaz/Gasztroenterologiai Osztaly | Vac | |
| Israel | Rabin Medical Center, Beilinson campus | Petah Tikva | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | SOC Gastroenterologia Centro di Riferimento Oncologico | Aviano | |
| Italy | AOU Mater Domini - U.O. Fisiopatologia Digestiva | Catanzaro | CZ |
| Italy | Ibd Center Irccs Humanitas | Milan | |
| Italy | A.O.R. Villa Sofia- Cervello | Palermo | PA |
| Italy | Comitato Etico Palermo 2 | Palermo | PA |
| Italy | Ospedali Riuniti Villa Sofia Cervello | Palermo | |
| Japan | Chiba University Hospital | Chiba-shi | Chiba |
| Japan | Fukuoka University Chikushi Hospital | Fukuoka | |
| Japan | Tokai University Hachioji Hospital | Hachioji | Tokyo |
| Japan | National Hospital Organization Mito Medical Center | Higashi-ibaraki-gun | Ibaraki |
| Japan | National Hospital Organization Hirosaki National Hospital | Hirosaki | Aomori |
| Japan | Hiroshima University Hospital | Hiroshima | |
| Japan | The Hospital of Hyogo College of Medicine | Hyogo | |
| Japan | Sameshima Hospital | Kagoshima | |
| Japan | Kuniyoshi Hopital | Kochi | |
| Japan | Kurume University Hospital | Kurume-shi | Fukuoka |
| Japan | Jikei University Hospital | Minato-ku | Tokyo |
| Japan | Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo |
| Japan | Aichi Medical University Hospital | Nagakute | Aichi |
| Japan | Osaka City University Hospital | Osaka | |
| Japan | Shiga University Of Medical Science | Otsu | Shiga |
| Japan | Toho University Sakura Medical Center | Sakura | Chiba |
| Japan | Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital | Sapporo | Hokkaido |
| Japan | National Hospital Organization Sendai Medical Center | Sendai | Miyagi |
| Japan | NTT Medical Center Tokyo | Shinagawa-ku | Tokyo |
| Japan | Showa University Hospital | Shinagawa-ku | Tokyo |
| Japan | Osaka Medical College Hospital | Takatsuki | Osaka |
| Japan | Keio University Hospital | Tokyo | |
| Japan | Tokyo Medical And Dental University Hospital, Faculty of Medicine | Tokyo | |
| Latvia | Digestive Diseases Center GASTRO | Riga | |
| Latvia | ECG room, Clinic "Linezers" | Riga | |
| Latvia | X-Ray Department, Clinic "Linezers" | Riga | |
| Netherlands | Leiden University Medical Center (LUMC) | Leiden | ZH |
| New Zealand | Southern District Health Board | Dunedin | |
| New Zealand | Shakespeare Specialist Group | Milford | Auckland |
| New Zealand | Bop Clinical School Clinical Trials Unit | Tauranga | |
| New Zealand | Tauranga Hospital | Tauranga | Bay of Plenty |
| Poland | Gabinet Lekarski - Janusz Rudzinski | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej | Lodz | |
| Poland | Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia | Warszawa | Mazowieckie |
| Poland | Lexmedica | Wroclaw | |
| Romania | Cabinet Particular Policlinic Algomed SRL | Timisoara | Jud Timis |
| Russian Federation | State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko | Nizhniy Novgorod | |
| Russian Federation | Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency" | Novosibirsk | |
| Russian Federation | Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital | Novosibirsk | |
| Russian Federation | State Budget Educational Institution of Higher Professional Education | Novosibirsk | |
| Russian Federation | Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk" | Pyatigorsk | Stavropol region |
| Russian Federation | GBOU VPO "Northwest State Medical Academy n.a. I.I. Mechnikov" | Saint Petersburg | |
| Russian Federation | GUZ City Hospital #26 | Saint Petersburg | |
| Russian Federation | Limited Liability Company Medical Company "Hepatolog" | Samara | Russia |
| Russian Federation | Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock | Samara | |
| Russian Federation | Samara Diagnostic center, X-ray Department | Samara | |
| Russian Federation | Federal State Budgetary Military Educational Institution of High Professional Education | St. Petersburg | |
| Serbia | Clinical Hospital Centre Zvezdara | Belgrade | |
| Serbia | Military Medical Academy Belgrade | Belgrade | |
| Serbia | Clinical Centre of Kragujevac | Kragujevac | |
| Serbia | General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology | Zrenjanin | Serbia, Europe |
| Slovakia | HPL spol. s r.o. | Bratislava | |
| Slovakia | Medak s.r.o. | Bratislava | |
| Slovakia | Prevencia a zdravie s.r.o. | Bratislava | |
| South Africa | Endocare Research Centre | Cape Town | Western Cape |
| South Africa | Chris Hani Baragwanath Academic Hospital | Johannesburg | Gauteng |
| Spain | Hospital Clinic I Provincial de Barcelona | Barcelona | |
| Spain | Hospital Clinico San Carlos | Madrid | |
| Spain | Hospital Universitario de Fuenlabrada | Madrid | |
| Spain | Hospital Universitario La Princesa | Madrid | |
| Ukraine | State Institution "National L.T. Malaya Therapy Institute of National Academy | Kharkov | |
| Ukraine | Kyiv Municipal Clinical Hospital #18, Proctology Department | Kyiv | |
| Ukraine | LTD "St. Paraskeva Medical Center" | Lviv | |
| Ukraine | Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital, | Lviv | |
| Ukraine | SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department, | Odesa | |
| Ukraine | InternalMedicineCenterofCrimean,GastroenterologicalDepartment,StateInstitution"CrimeanStateMedicalUn | Simferopol | AR Krym |
| Ukraine | Local Laboratory of I.M.C. of Crimean Republic Institution "Clinical Territorial Medical Community " | Simferopol | AR Krym |
| Ukraine | SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI | Uzhgorod | |
| Ukraine | Vinnytsia National Medical University | Vinnytsia | |
| Ukraine | Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2 | Vinnytsya | |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | University College Hospital | London | |
| United States | Georgia Endoscopy Center (Colonoscopy only) | Alpharetta | Georgia |
| United States | Florida Surgery Center | Altamonte Springs | Florida |
| United States | East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems | Ann Arbor | Michigan |
| United States | Medical Science Research Building 1 - University of Michigan Health Systems | Ann Arbor | Michigan |
| United States | Michigan Clinical Research Unit - Univeristy of Michigan Health System | Ann Arbor | Michigan |
| United States | Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only) | Ann Arbor | Michigan |
| United States | University of Michigan Health Systems | Ann Arbor | Michigan |
| United States | GI Consultants (Colonoscopy only) | Atlanta | Georgia |
| United States | Clevland Clinic Department of Pharmacy | Cleveland | Ohio |
| United States | NYU Langone Long Island Clinical Research Associates | Great Neck | New York |
| United States | NYU Langone Nassau Gastroenterology Associates | Great Neck | New York |
| United States | Endoscopy Center of Connecticut, LLC | Guilford | Connecticut |
| United States | Endoscopy Center of Connecticut, LLC | Hamden | Connecticut |
| United States | Gastroenterology Center of Connecticut, PC | Hamden | Connecticut |
| United States | Medical Research Center of Connecticut, LLC | Hamden | Connecticut |
| United States | Sunrise Medical Labs | Hicksville | New York |
| United States | Baylor College of Medicine - Baylor Medical Center (Drug Storage) | Houston | Texas |
| United States | Baylor Medical Center | Houston | Texas |
| United States | Gastroenterology Consultants, P.A. | Houston | Texas |
| United States | Houston Hospital for Specialized Surgery | Houston | Texas |
| United States | Emory Healthcare Heart Center (EKG) | Johns Creek | Georgia |
| United States | Investigational Drug Pharmacy, UCSD Health System, Moores Cancer Center | La Jolla | California |
| United States | UCSD Medical Center | La Jolla | California |
| United States | Cedars Sinai Medical Center - Thalians Bldg | Los Angeles | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center | Los Angeles | California |
| United States | CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center | Los Angeles | California |
| United States | MD Office - Cedars-Sinai Medical Center Suite 203 E | Los Angeles | California |
| United States | Regulatory Office - Cedars-Sinai Medical Center - Imflammatory Bowel Disease Center | Los Angeles | California |
| United States | Gastroenterology Associates of Central Georgia | Macon | Georgia |
| United States | Center for Advanced Gastroenterology | Maitland | Florida |
| United States | MNH Surgical Center | Maitland | Florida |
| United States | Sand Lake Imaging | Maitland | Florida |
| United States | Great Lakes Gastroenterology | Mentor | Ohio |
| United States | Center for Digestive Health | Milwaukee | Wisconsin |
| United States | Wisconsin Center for Advanced Research - GI Associates, LLC | Milwaukee | Wisconsin |
| United States | Horizon Research Group, Inc. | Mobile | Alabama |
| United States | Internal Medicine Center, LLC | Mobile | Alabama |
| United States | Springhill Memorial Hospital | Mobile | Alabama |
| United States | Columbia University Medical Center | New York | New York |
| United States | CUMC Research Pharmacy | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | Kornbluth, Legnani, George MD, PC | New York | New York |
| United States | Mount Sinai Doctos Faculty Practice | New York | New York |
| United States | The Private Practice of Simon Lichtiger, MD | New York | New York |
| United States | Southwest Gastroenterology | Oak Lawn | Illinois |
| United States | North Florida Gastroenterology Research, LLC | Orange Park | Florida |
| United States | Orange Park Surgery Center | Orange Park | Florida |
| United States | Citrus Ambulatory Surgery Center | Orlando | Florida |
| United States | Internal Medicine Specialists | Orlando | Florida |
| United States | Desert Advanced Imaging | Palm Springs | California |
| United States | Erik Palmer, DO | Palm Springs | California |
| United States | Homan A Zadeh, MD, MPH | Palm Springs | California |
| United States | Hope Square Surgical Center | Rancho Mirage | California |
| United States | Center for Advanced Medicine | Saint Louis | Missouri |
| United States | Washington University School of Medicine - Division of Gastroenterology | Saint Louis | Missouri |
| United States | Wasatch Clinical Research | Salt Lake City | Utah |
| United States | Sharp Rees-Stealy | San Diego | California |
| United States | Sharp Rees-Stealy Medical Group | San Diego | California |
| United States | Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia |
| United States | Johns Creek Diagnostic Center (X-Ray only) | Suwanee | Georgia |
| United States | Shafran Gastroenterology Center | Winter Park | Florida |
| United States | Huron Gastroenterology Associates / Center for Digestive Care | Ypsilanti | Michigan |
| United States | Michigan Heart SJMH | Ypsilanti | Michigan |
| United States | Saint Joseph Mercy Hospital Outpatient Laboratory | Ypsilanti | Michigan |
| United States | Florida Medical Clinic, P.A. | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Austria, Belgium, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, 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. | based on the Mayo score | 8 weeks | No |
| Secondary | The proportion of subjects in clinical remission at Week 8. | based on the Mayo score | 8 weeks | No |
| Secondary | The proportion of subjects in symptomatic remission at Week 8. | based on the Mayo score | 8 weeks | No |
| Secondary | The proportion of subjects achieving deep remission at Week 8. | based on the Mayo score | 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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