Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01465763
Registration number
NCT01465763
Ethics application status
Date submitted
21/10/2011
Date registered
6/11/2011
Date last updated
7/06/2016
Titles & IDs
Public title
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2011-004578-27
Query!
Secondary ID [2]
0
0
A3921094
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
OCTAVE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - tofacitinib
Treatment: Drugs - Placebo
Experimental: tofacitinib 10 mg BID -
Placebo comparator: Placebo -
Treatment: Drugs: tofacitinib
10 mg oral BID
Treatment: Drugs: Placebo
Plabebo oral BID
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Remission at Week 8
Query!
Assessment method [1]
0
0
Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Query!
Timepoint [1]
0
0
Week 8
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving Mucosal Healing at Week 8
Query!
Assessment method [1]
0
0
Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Query!
Timepoint [1]
0
0
Week 8
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving Clinical Response at Week 8
Query!
Assessment method [2]
0
0
Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Query!
Timepoint [2]
0
0
Week 8
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Endoscopic Remission at Week 8
Query!
Assessment method [3]
0
0
Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Query!
Timepoint [3]
0
0
Week 8
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Clinical Remission at Week 8
Query!
Assessment method [4]
0
0
Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Query!
Timepoint [4]
0
0
Week 8
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Symptomatic Remission at Week 8
Query!
Assessment method [5]
0
0
Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Query!
Timepoint [5]
0
0
Week 8
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Deep Remission at Week 8
Query!
Assessment method [6]
0
0
Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Query!
Timepoint [6]
0
0
Week 8
Query!
Secondary outcome [7]
0
0
Partial Mayo Scores
Query!
Assessment method [7]
0
0
A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.
Query!
Timepoint [7]
0
0
Baseline, Weeks 2, 4, 8
Query!
Secondary outcome [8]
0
0
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Query!
Assessment method [8]
0
0
Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.
Query!
Timepoint [8]
0
0
Baseline, Weeks 2, 4, 8
Query!
Secondary outcome [9]
0
0
Change From Baseline in Total Mayo Scores at Week 8
Query!
Assessment method [9]
0
0
Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Query!
Timepoint [9]
0
0
Baseline, Week 8
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
614
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [3]
0
0
Eastern Health Box Hill Hospital - Box Hill
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [3]
0
0
3128 - Box Hill
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Utah
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Wisconsin
Query!
Country [14]
0
0
Austria
Query!
State/province [14]
0
0
Wien
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Leuven
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Alberta
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Ontario
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Quebec
Query!
Country [19]
0
0
Colombia
Query!
State/province [19]
0
0
Atlantico
Query!
Country [20]
0
0
Croatia
Query!
State/province [20]
0
0
Zadar
Query!
Country [21]
0
0
Czech Republic
Query!
State/province [21]
0
0
Hradec Kralove
Query!
Country [22]
0
0
Czech Republic
Query!
State/province [22]
0
0
Praha 4
Query!
Country [23]
0
0
Czech Republic
Query!
State/province [23]
0
0
Praha 7
Query!
Country [24]
0
0
Denmark
Query!
State/province [24]
0
0
Aalborg
Query!
Country [25]
0
0
Denmark
Query!
State/province [25]
0
0
Aarhus C
Query!
Country [26]
0
0
Estonia
Query!
State/province [26]
0
0
Tallinn
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Nantes
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Paris
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Toulouse Cedex 9
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Berlin
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Halle
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Hannover
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Lüneburg
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Budapest
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Pecs
Query!
Country [36]
0
0
Hungary
Query!
State/province [36]
0
0
Szeged
Query!
Country [37]
0
0
Hungary
Query!
State/province [37]
0
0
Vac
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Petah Tikva
Query!
Country [39]
0
0
Israel
Query!
State/province [39]
0
0
Tel Aviv
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
CZ
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Milano
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
PA
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Aviano
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Milan
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Aichi
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Aomori
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Chiba
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Fukuoka
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Hokkaido
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Hyogo
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Ibaraki
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Kochi
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Miyagi
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Osaka
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Shiga
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Tokyo
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Hiroshima
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Kagoshima
Query!
Country [59]
0
0
Latvia
Query!
State/province [59]
0
0
Riga
Query!
Country [60]
0
0
Netherlands
Query!
State/province [60]
0
0
ZH
Query!
Country [61]
0
0
New Zealand
Query!
State/province [61]
0
0
Auckland
Query!
Country [62]
0
0
New Zealand
Query!
State/province [62]
0
0
Dunedin
Query!
Country [63]
0
0
New Zealand
Query!
State/province [63]
0
0
Tauranga
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Kujawsko-pomorskie
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Mazowieckie
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Lodz
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Wroclaw
Query!
Country [68]
0
0
Romania
Query!
State/province [68]
0
0
Jud Timis
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Stavropol Region
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Nizhniy Novgorod
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Novosibirsk
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Saint-Petersburg
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Samara
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
St. Petersburg
Query!
Country [75]
0
0
Serbia
Query!
State/province [75]
0
0
Serbia, Europe
Query!
Country [76]
0
0
Serbia
Query!
State/province [76]
0
0
Belgrade
Query!
Country [77]
0
0
Serbia
Query!
State/province [77]
0
0
Kragujevac
Query!
Country [78]
0
0
Slovakia
Query!
State/province [78]
0
0
Bratislava
Query!
Country [79]
0
0
South Africa
Query!
State/province [79]
0
0
Gauteng
Query!
Country [80]
0
0
South Africa
Query!
State/province [80]
0
0
Western Cape
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Barcelona
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Madrid
Query!
Country [83]
0
0
Ukraine
Query!
State/province [83]
0
0
Ar Krym
Query!
Country [84]
0
0
Ukraine
Query!
State/province [84]
0
0
Kharkov
Query!
Country [85]
0
0
Ukraine
Query!
State/province [85]
0
0
Kyiv
Query!
Country [86]
0
0
Ukraine
Query!
State/province [86]
0
0
Lviv
Query!
Country [87]
0
0
Ukraine
Query!
State/province [87]
0
0
Odesa
Query!
Country [88]
0
0
Ukraine
Query!
State/province [88]
0
0
Uzhgorod
Query!
Country [89]
0
0
Ukraine
Query!
State/province [89]
0
0
Vinnytsia
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Cambridge
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01465763
Query!
Trial related presentations / publications
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z. 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. 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. 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. 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. 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. 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. 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. 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. Erratum In: Intest Res. 2018 Jul;16(3):499-501. doi: 10.5217/ir.2018.16.3.499. 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. Erratum In: J Crohns Colitis. 2019 Jan 1;13(1):139-140. doi: 10.1093/ecco-jcc/jjy135. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01465763
Download to PDF