Clinical trial NCT01458951: A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active 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: 2011-10-25
Enrollment: 547
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 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 Score at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Desert Sun Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Gastroenterology
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Surgery Center
state: Arizona
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: San Diego
country: United States
facility: Clinical Application Laboratories
state: California
city: San Diego
country: United States
facility: San Diego Endoscopy Center
state: California
city: San Francisco
country: United States
facility: UCSF Endoscopy Unit at Mount Zion
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Bristol
country: United States
facility: Bristol Hospital
state: Connecticut
city: Bristol
country: United States
facility: Connecticut Clinical Research Foundation
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Plainville
country: United States
facility: Central Connecticut Endoscopy Center
state: Connecticut
city: Crystal River
country: United States
facility: Citrus Surgery & Endoscopy Center (Colonoscopy)
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Inverness
country: United States
facility: Suncoast Endoscopy Center (colonoscopy)
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Port Orange
country: United States
facility: Advanced Gastroenterology Center
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Port Orange
country: United States
facility: Endoscopy Center
state: Florida
city: Port Orange
country: United States
facility: Port Orange Urgent Care
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Shreveport
country: United States
facility: Gastrointestinal Specialists, A.M.C.
state: Louisiana
city: Shreveport
country: United States
facility: Shreveport Endoscopy Center, A.M.C.
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center (Endoscopies Only)
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Troy
country: United States
facility: Surgical Centers of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: Surgery Center of Columbia
state: Missouri
city: Hannibal
country: United States
facility: Hannibal Regional Hospital
state: Missouri
city: Mexico
country: United States
facility: Audrain Medical Center
state: Missouri
city: Mexico
country: United States
facility: Center for Digestive & Liver Disease, Inc.
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Marlton
country: United States
facility: South Jersey Gastroenterology
state: New Jersey
city: Vineland
country: United States
facility: The Gastroenterology Group of South Jersey
state: New Jersey
city: Voorhees
country: United States
facility: The Endo Center at Voorhees
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Greenville
country: United States
facility: Carolina Research - Carolina Digestive Diseases
state: North Carolina
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - IBD Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - GI Research Office
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Drug Shipment
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - GCRC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Heart Station
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Radiology
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institiute
state: Texas
city: Austin
country: United States
facility: Austin Gastroenterology PA/Professional Quality Research, Inc.
state: Texas
city: Austin
country: United States
facility: Austin Gastroenterology PA
state: Texas
city: Austin
country: United States
facility: Austin Endoscopy Center II
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Richmond
country: United States
facility: VCU Health System Digestive Health Center
state: Virginia
city: Richmond
country: United States
facility: VCU Health System Endoscopy Suite
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center Investigational Drug Service (IDS)
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University, Clinical Research Services (CRSU)
state: Virginia
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Concord
country: Australia
facility: Concord Hospital -Concord Repatriation Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital Eastern Campus
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
city: St. Veit an der Glan
country: Austria
facility: Krankenhaus Barmherzige Brueder St. Veit/Glan
city: Antwerpen
country: Belgium
facility: GZA St Vincentius
city: Kortrijk
country: Belgium
facility: AZ Groeninge, Campus Kennedylaan
city: Roeselare
country: Belgium
facility: H-Hartziekenhuis Roeselare-Menen vzw
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre - HCPA
state: Rio Grande do Sul
city: Edmonton
country: Canada
facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta - Zeidler Ledcor Centre
state: Alberta
city: Montreal
country: Canada
facility: Montreal General Hospital - McGill University Health Centre
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon City Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Medellin
country: Colombia
facility: Instituto de Coloproctologia ICO S.A.S.
state: Antioquia
city: Osijek
country: Croatia
facility: University Hospital Center Osijek, Clinic of Internal Medicine,
city: Rijeka
country: Croatia
facility: University Hospital Center Rijeka
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb,Department of Gastroenterology
city: Strakonice
country: Czech Republic
facility: Nemocnice Strakonice, a.s., Interni oddeleni
city: Usti nad Labem
country: Czech Republic
facility: Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Tallinn
country: Estonia
facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
city: Tallinn
country: Estonia
facility: Innomedica OU
city: Tallinn
country: Estonia
facility: X-Ray Unit, Qualitas AS (X-Ray Only)
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital Internal Medicine Clinic
city: Tallinn
country: Estonia
facility: ECG Unit, East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: X-Ray Unit, East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Quattromed HTI Laboratorid OU
city: Tallinn
country: Estonia
facility: Mammograaf OU (Endoscopy Only)
city: Amiens Cedex 1
country: France
facility: CHU Amiens PICARDIE - Hopital SUD
city: Bordeaux cedex
country: France
facility: Hopital Saint Andre
city: Clichy Cedex
country: France
facility: Hopital Beaujon
city: Paris Cedex 12
country: France
facility: Hopital Saint Antoine
city: Reims cedex
country: France
facility: C.H.U. de Reims - Hôpital Robert Debré
city: St Priest En Jarez
country: France
facility: Hopital Nord
city: Kiel
country: Germany
facility: Universitäetsklinik Schleswig-Holstein, Campus Kiel
state: Schlewig Holstein
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Munich
country: Germany
facility: University Hospital Munich-Grosshadern
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Bekescsaba
country: Hungary
facility: Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat
state: Europe
city: Budapest
country: Hungary
facility: Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
city: Budapest
country: Hungary
facility: MH Honvedkorhaz
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Mosonmagyarovar
country: Hungary
facility: "Karolina Korhaz Rendelointezet,Belgyogyaszat
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Holon
country: Israel
facility: The Edith Wolfson Medical Center/Gastroenterology Institute
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital, Clinical Laboratory
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Amsterdam
country: Netherlands
facility: VU University Medical Center (VUMC)
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre (AMC),
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: P3 Research Limited
city: Wellington
country: New Zealand
facility: Pacific Radiology (X-rays only)
city: Wellington
country: New Zealand
facility: Bowen Hospital
city: Lodz
country: Poland
facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
state: Iodzkie
city: Bydgoszcz
country: Poland
facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
state: Kujawsko-pomorskie
city: Bialystok
country: Poland
facility: Oddzial Chorob Wewnetrznych i Gastroenterologii,
state: Podlaskie
city: Tychy
country: Poland
facility: H-T Centrum Medyczne sp. z o.o. sp. komandytowa
state: Slaskie
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Sopot
country: Poland
facility: Endoskopia Sp. z.o.o.
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
state: Sector 5
city: jud. Mures
country: Romania
facility: Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
city: Moscow
country: Russian Federation
facility: State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
state: Russia
city: Yaroslavl
country: Russian Federation
facility: Municipal institution of healthcare "Clinical Hospital # 2"
state: Russia
city: Yaroslavl
country: Russian Federation
facility: OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
state: Russia
city: Moscow
country: Russian Federation
facility: Federal state budget institution "State scientific centre of coloproctology"
city: Moscow
country: Russian Federation
facility: State budget Healthcare Institution Moscow regional scientific research clinical institute
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Institution "Scientific Research Institute of Physiology and
city: Saratov
country: Russian Federation
facility: Municipal institution of healthcare "City clinical hospital 12"
city: Yaroslavl
country: Russian Federation
facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division
city: Subotica
country: Serbia
facility: General Hospital Subotica
city: Bratislava
country: Slovakia
facility: Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Nove Mesto Nad Vahom
country: Slovakia
facility: Aura SA, s.r.o.
city: Presov
country: Slovakia
facility: Gastro I., s.r.o.
city: Cape Town
country: South Africa
facility: Panorama Medi-Clinic
state: Western Cape
city: Cape Town
country: South Africa
facility: The Louis Leipoldt Medical Centre
state: Western Cape
city: Claremont, Cape Town
country: South Africa
facility: Dr JP Wright
state: Western Cape
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Chernivtsi,
country: Ukraine
facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital
city: Dnipropetrovsk
country: Ukraine
facility: State Institution Institute of Gastroenterology of the National Academy of Medical Sciences
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
city: Kiev
country: Ukraine
facility: Kyiv City Clinical Hospital #8,
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital"
city: Vinnytsya
country: Ukraine
facility: Medical Clinical Research Center "Health Clinic" on the base of
city: Zaporizhzhia
country: Ukraine
facility: Motor-Sich clinic, LLC
city: Zaporizhzhia
country: Ukraine
facility: Minicipal Institution "City Hospital #7" Therapeutic Department,
city: Bristol
country: United Kingdom
facility: Department of Gastroenterology, Old Building
state: England
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
state: Middlesex
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University 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.
citation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.
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.
citation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.
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.
citation: Dubinsky MC, DiBonaventura M, Fan H, Bushmakin AG, Cappelleri JC, Maller E, Thorpe AJ, Salese L, Panes J. Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):983-993. doi: 10.1093/ibd/izaa193.
citation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.
citation: Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.
citation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.
citation: Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.
citation: Hanauer S, Panaccione R, Danese S, Cheifetz A, Reinisch W, Higgins PDR, Woodworth DA, Zhang H, Friedman GS, Lawendy N, Quirk D, Nduaka CI, Su C. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-147. doi: 10.1016/j.cgh.2018.07.009. Epub 2018 Sep 10.
citation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.
citation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30.
citation: Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133.
citation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.