Clinical trial NCT01465763: A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: tofacitinib
CP-690
550
Moderate to severe ulcerative colitis
phase 3 clinical trial
Mayo score
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Remission at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants Achieving Mucosal Healing at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving Clinical Response at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Endoscopic Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Clinical Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Symptomatic Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Deep Remission at Week 8
timeFrame: Week 8
measure: Partial Mayo Scores
timeFrame: Baseline, Weeks 2, 4, 8
measure: Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
timeFrame: Baseline, Weeks 2, 4, 8
measure: Change From Baseline in Total Mayo Scores at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Internal Medicine Center, LLC
state: Alabama
city: Mobile
country: United States
facility: Springhill Memorial Hospital
state: Alabama
city: La Jolla
country: United States
facility: Investigational Drug Service Pharmacy
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Medical Centre
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center - Thalians Bldg
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Surgery Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
state: California
city: Palm Springs
country: United States
facility: Desert Advanced Imaging
state: California
city: Palm Springs
country: United States
facility: Erik Palmer, DO
state: California
city: Palm Springs
country: United States
facility: Homan A Zadeh, MD, MPH
state: California
city: Rancho Mirage
country: United States
facility: Hope Square Surgical Center
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group,Inc
state: California
city: Guilford
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Gastroenterology Center of Connecticut, PC
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Altamonte Springs
country: United States
facility: Florida Surgery Center
state: Florida
city: Maitland
country: United States
facility: Center for Advanced Gastroenterology
state: Florida
city: Maitland
country: United States
facility: MNH Surgical Center
state: Florida
city: Maitland
country: United States
facility: Sand Lake Imaging
state: Florida
city: Orange Park
country: United States
facility: North Florida Gastroenterology Research, LLC
state: Florida
city: Orange Park
country: United States
facility: Orange Park Surgery Center
state: Florida
city: Orlando
country: United States
facility: Citrus Ambulatory Surgery Center
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: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Alpharetta
country: United States
facility: Georgia Endoscopy Center (Colonoscopy only)
state: Georgia
city: Atlanta
country: United States
facility: GI Consultants (Colonoscopy only)
state: Georgia
city: Johns Creek
country: United States
facility: Emory Healthcare Heart Center (EKG)
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Suwanee
country: United States
facility: Johns Creek Diagnostic Center (X-Ray only)
state: Georgia
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
state: Michigan
city: Ann Arbor
country: United States
facility: East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Unit - Univeristy of Michigan Health System
state: Michigan
city: Ann Arbor
country: United States
facility: Medical Science Research Building 1 - University of Michigan Health Systems
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart SJMH (Blood draws and ECGs only)
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates / Center for Digestive Care
state: Michigan
city: Ypsilanti
country: United States
facility: Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)
state: Michigan
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Division of Gastroenterology
state: Missouri
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Great Neck
country: United States
facility: NYU Langone Nassau Gastroenterology Associates
state: New York
city: New York
country: United States
facility: The Private Practice of Simon Lichtiger, MD
state: New York
city: New York
country: United States
facility: Mount Sinai Doctos Faculty Practice
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: CUMC Research Pharmacy
state: New York
city: New York
country: United States
facility: Kornbluth, Legnani, George MD, PC
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Mentor
country: United States
facility: Mentor Medical Campus
state: Ohio
city: Mentor
country: United States
facility: The Endoscopy Center of Lake County
state: Ohio
city: Houston
country: United States
facility: Houston Hospital for Specialized Surgery
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine (Baylor Medical Center)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Medical Center (Drug Storage)
state: Texas
city: Houston
country: United States
facility: Gastroenterology Consultants, P.A.
state: Texas
city: Salt Lake City
country: United States
facility: Alpine Medical Group
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Endoscopy Center
state: Utah
city: West Jordan
country: United States
facility: RGL Medical Services (x-ray only)
state: Utah
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research - GI Associates, LLC
state: Wisconsin
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Health Box Hill Hospital
state: Victoria
city: Wien
country: Austria
facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III,
city: Leuven
country: Belgium
facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
city: Calgary
country: Canada
facility: Hertiage Medical Research Clinic- University Of Calgary
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation - McMaster University Medical Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Barranquilla
country: Colombia
facility: Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.
state: Atlantico
city: Zadar
country: Croatia
facility: General Hospital Zadar
city: Hradec Kralove
country: Czech Republic
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Praha 4
country: Czech Republic
facility: Institut klinicke a experimentalni mediciny
city: Praha 7
country: Czech Republic
facility: Klinicke Centrum ISCARE I.V.F.
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Tallinn
country: Estonia
facility: ECG Unit of West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital Internal Diseases Clinic
city: Tallinn
country: Estonia
facility: X-Ray Department of West Tallinn Central Hospital
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu
city: Paris
country: France
facility: Hopital Saint-Louis
city: Toulouse Cedex 9
country: France
facility: Hopital Rangueil
city: Berlin
country: Germany
facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lüneburg
country: Germany
facility: Klinikum Luneburg/Abteilung Gastroenterologie
city: Budapest
country: Hungary
facility: Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
city: Vac
country: Hungary
facility: Javorszky Odon Korhaz/Gasztroenterologiai Osztaly
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Catanzaro
country: Italy
facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva
state: CZ
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCSS
state: Milano
city: Palermo
country: Italy
facility: A.O.R. Villa Sofia- Cervello
state: PA
city: Palermo
country: Italy
facility: Comitato Etico Palermo 2
state: PA
city: Aviano
country: Italy
facility: SOC Gastroenterologia Centro di Riferimento Oncologico
city: Milan
country: Italy
facility: IBD Center - IRCCS Humanitas
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki National Hospital
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
city: Higashi-ibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
state: Ibaraki
city: Kochi-shi
country: Japan
facility: Kuniyoshi Hospital
state: Kochi
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi
city: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kagoshima
country: Japan
facility: Sameshima Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Riga
country: Latvia
facility: Digestive Diseases Center GASTRO
city: Riga
country: Latvia
facility: ECG room, Clinic "Linezers"
city: Riga
country: Latvia
facility: X-Ray Department, Clinic "Linezers"
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: ZH
city: Milford
country: New Zealand
facility: Shakespeare Specialist Group
state: Auckland
city: Dunedin
country: New Zealand
facility: Southern District Health Board
city: Tauranga
country: New Zealand
facility: Bop Clinical School Clinical Trials Unit
city: Bydgoszcz
country: Poland
facility: Gabinet Lekarski - Janusz Rudzinski
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia
state: Mazowieckie
city: Lodz
country: Poland
facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki
city: Wroclaw
country: Poland
facility: Lexmedica
city: Timisoara
country: Romania
facility: Cabinet Particular Policlinic Algomed SRL
state: Jud Timis
city: Pyatigorsk
country: Russian Federation
facility: Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"
state: Stavropol Region
city: Nizhniy Novgorod
country: Russian Federation
facility: State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"
city: Novosibirsk
country: Russian Federation
facility: Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: State Budget Educational Institution of Higher Professional Education
city: Saint-Petersburg
country: Russian Federation
facility: GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"
city: Saint-Petersburg
country: Russian Federation
facility: GUZ City Hospital #26
city: Samara
country: Russian Federation
facility: Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock
city: Samara
country: Russian Federation
facility: Limited Liability Company Medical Company "Hepatolog"
city: Samara
country: Russian Federation
facility: Samara Diagnostic center, X-ray Department
city: St. Petersburg
country: Russian Federation
facility: Federal State Budgetary Military Educational Institution of High Professional Education
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology
state: Serbia, Europe
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: Clinical Centre of Kragujevac
city: Bratislava
country: Slovakia
facility: Medak s.r.o.
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Gauteng
city: Cape Town
country: South Africa
facility: Endocare Research Centre
state: Western Cape
city: Barcelona
country: Spain
facility: Hospital Clínic i provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Simferopol
country: Ukraine
facility: InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University
state: Ar Krym
city: Kharkov
country: Ukraine
facility: State Institution "National L.T. Malaya Therapy Institute of National Academy
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #18, Proctology Department
city: Lviv
country: Ukraine
facility: LTD "St. Paraskeva Medical Center"
city: Lviv
country: Ukraine
facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
city: Odesa
country: Ukraine
facility: SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
city: Uzhgorod
country: Ukraine
facility: SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI
city: Vinnytsia
country: Ukraine
facility: Vinnytsia National Medical University
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals Nhs Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.
citation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.
citation: 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.
citation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.
citation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.
citation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.
citation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.
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citation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.
citation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.
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citation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.
citation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.
citation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
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