A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
NCT ID: NCT03281304
Last Updated: 2023-03-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
140 participants
INTERVENTIONAL
2017-11-16
2022-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CP-690,550 5 mg
CP-690,550 5 mg tablet by mouth twice a day (BID)
CP-690,500 5 mg
CP-690,550 5 mg tablet BID
CP-690,550 10 mg
CP-690,550 10 mg BID
CP-690,550 10 mg
CP-690,550 10 mg tablet BID
Interventions
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CP-690,500 5 mg
CP-690,550 5 mg tablet BID
CP-690,550 10 mg
CP-690,550 10 mg tablet BID
Eligibility Criteria
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Inclusion Criteria
* In stable remission on CP-690,550 10 mg BID
* Agree to use highly effective contraception
* Negative pregnancy test
* Comply with visits, treatments, lab tests, diary and other study procedures
* Signed and dated informed consent document.
Exclusion Criteria
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease
* Likely to require surgery for ulcerative colitis during study
* Expected to receive any prohibited medication
* Expected to receive live or attenuated virus vaccination during study
* Women who are pregnant or breastfeeding or planning to become pregnant during the study
* Evidence of colonic malignancy or any dysplasia
* Acute or chronic medical or psychiatric condition that may increase risk of participation
* Investigator site staff member
* Subjects likely to be uncooperative or unable to comply with study procedures
* Participation in other studies involving investigational drugs during study
* Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:
* has heart failure;
* has inherited coagulation disorders;
* has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism;
* is taking combined hormonal contraceptives or hormone replacement therapy;
* has malignancy (association is strongest with cancers other than non-melanoma skin cancers);
* is undergoing major surgery
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Surgicare of Mobile
Mobile, Alabama, United States
Alabama Medical Group, P.C.
Mobile, Alabama, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
Bristol Hospital
Bristol, Connecticut, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, United States
Central Connecticut Endoscopy Center
Plainville, Connecticut, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Eastside Endoscopy Center
Macomb, Michigan, United States
Clinical Research Institute of Michigan, LLC
Troy, Michigan, United States
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Columbia University Medical Center Research Pharmacy/ Milstein Hospital
New York, New York, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Memorial Hermann Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School
Houston, Texas, United States
Christus Trinity Mother Frances Endoscopy Center
Tyler, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Alpine Medical Group
Salt Lake City, Utah, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
Leuven, , Belgium
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Nemocnice Strakonice a.s.
Strakonice, , Czechia
CHU Hotel Dieu
Nantes, , France
CHU de Bordeaux Hopital Haut Leveque
Pessac, , France
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak
Budapest, , Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium
Gyula, , Hungary
Università "Magna Graecia" di Catanzaro
Catanzaro, CZ, Italy
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital
Hachiōji, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, Japan
Toho University Sakura Medical Center
Chiba, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Keio University Hospital
Tokyo, , Japan
Academic Medical Centre
Amsterdam, , Netherlands
North Shore Hospital (Waitemata District Health Board)
Takapuna, Auckland, New Zealand
Christchurch Hospital (Canterbury District Health Board)
Christchurch, , New Zealand
Southern District Health Board
Dunedin, , New Zealand
Endoskopia Sp. z o.o.
Sopot, , Poland
Lexmedica
Wroclaw, , Poland
Federal State Budgetary Institution "State Scientific Centre of Coloproctology
Moscow, , Russia
LLC Novosibirskiy Gastrocenter
Novosibirsk, , Russia
Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology
Novosibirsk, , Russia
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
Belgrade, , Serbia
Clinical Hospital Centre Zvezdara
Belgrade, , Serbia
Military Medical Academy, Clinic for Gastroenterology and Hepatology
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, , Serbia
Medak s.r.o.
Bratislava, , Slovakia
KM Management spol. s.r.o.
Nitra, , Slovakia
Gastro I., s.r.o., Gastroenterologicka ambulancia
Prešov, , Slovakia
Kingsbury Hospital
Claremont, CAPE TOWN, South Africa
Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital
Soweto, Johannesburg, Gauteng, South Africa
Chris Hani Baragwanath Academic Hospital
Soweto, Johannesburg, South Africa
Endocare Research Centre
Paarl, Western Cape, South Africa
Panorama Mediclinic
Panorama, Western Cape, South Africa
Hanyang University Guri Hospital
Gyeonggi-do, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm
Chernivtsi, , Ukraine
Kyiv Municipal Clinical Hospital #18
Kyiv, , Ukraine
MI Uzhgorod Regional Hospital
Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
Vinnytsia, , Ukraine
University Hospitals Bristol NHS Foundation Trust
Bristol, AVON, United Kingdom
Countries
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References
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Torres J, D'Haens GR, Regueiro M, Santana G, Panes J, Vermeire S, Gardiner S, Kulisek N, Modesto I, Su C, Lawendy N, Mundayat R, Paulissen J, Dubinsky MC. Potential predictors of efficacy outcomes following tofacitinib dose reduction in patients with ulcerative colitis in stable remission: a post hoc analysis of outcomes from the RIVETING study. Therap Adv Gastroenterol. 2025 Feb 27;18:17562848251318849. doi: 10.1177/17562848251318849. eCollection 2025.
Panes J, D'Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N, Guo X, Wu J, Vranic I, Panaccione R, Vermeire S. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024 Jul;12(6):793-801. doi: 10.1002/ueg2.12584. Epub 2024 May 22.
Rubin DT, Torres J, Regueiro M, Reinisch W, Prideaux L, Kotze PG, Tan FH, Gardiner S, Mundayat R, Cadatal MJ, Ng SC. Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis. Crohns Colitis 360. 2024 Jan 20;6(1):otae004. doi: 10.1093/crocol/otae004. eCollection 2024 Jan.
Sandborn WJ, D'Haens GR, Sands BE, Panaccione R, Ng SC, Lawendy N, Kulisek N, Modesto I, Guo X, Mundayat R, Su C, Vranic I, Panes J. Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme. J Crohns Colitis. 2023 Apr 3;17(3):338-351. doi: 10.1093/ecco-jcc/jjac141.
Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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RIVETING STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
2017-002274-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921288
Identifier Type: -
Identifier Source: org_study_id
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