A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
NCT ID: NCT00787202
Last Updated: 2013-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2008-12-31
2010-09-30
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
TRIPLE
Study Groups
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15 mg BID
CP- 690 550
Administration via oral route twice daily for the duration of treatment
10 mg BID
CP- 690 550
Administration via oral route twice daily for the duration of treatment
3 mg BID
CP- 690 550
Administration via oral route twice daily for the duration of treatment
0.5 mg BID
CP- 690 550
Administration via oral route twice daily for the duration of treatment
Placebo
placebo
Administration via oral route twice daily for the duration of treatment
Interventions
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CP- 690 550
Administration via oral route twice daily for the duration of treatment
CP- 690 550
Administration via oral route twice daily for the duration of treatment
CP- 690 550
Administration via oral route twice daily for the duration of treatment
CP- 690 550
Administration via oral route twice daily for the duration of treatment
placebo
Administration via oral route twice daily for the duration of treatment
Eligibility Criteria
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Inclusion Criteria
* Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
* Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
* Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.
Exclusion Criteria
* Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
* Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon
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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Pfizer Investigational Site
Antwerp, , Belgium
Pfizer Investigational Site
Ghent, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Independencia, Santiago Metropolitan, Chile
Pfizer Investigational Site
Independencia, Santiago RM, Chile
Pfizer Investigational Site
Viña del Mar, , Chile
Pfizer Investigational Site
Hradec Králové, , Czechia
Pfizer Investigational Site
Olomouc, , Czechia
Pfizer Investigational Site
Usti N. Labem, , Czechia
Pfizer Investigational Site
Ústí nad Labem, , Czechia
Pfizer Investigational Site
Aalborg, , Denmark
Pfizer Investigational Site
Aarhus C, , Denmark
Pfizer Investigational Site
Lille, France, France
Pfizer Investigational Site
Bordeaux, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Nantes, , France
Pfizer Investigational Site
Békéscsaba, , Hungary
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Debrecen, , Hungary
Pfizer Investigational Site
Győr, , Hungary
Pfizer Investigational Site
Gyula, , Hungary
Pfizer Investigational Site
Kaposvár, , Hungary
Pfizer Investigational Site
Miskolc, , Hungary
Pfizer Investigational Site
Mosonmagyaróvár, , Hungary
Pfizer Investigational Site
Szeged, , Hungary
Pfizer Investigational Site
Szekszárd, , Hungary
Pfizer Investigational Site
Szentes, , Hungary
Pfizer Investigational Site
Haifa, , Israel
Pfizer Investigational Site
Petah Tikva, , Israel
Pfizer Investigational Site
Tel Aviv, , Israel
Pfizer Investigational Site
Bologna, , Italy
Pfizer Investigational Site
Roma, , Italy
Pfizer Investigational Site
Delegacion Benito Juarez, Mexico DF, Mexico
Pfizer Investigational Site
Tlalpan, Mexico DF, Mexico
Pfizer Investigational Site
Amsterdam, North Holland, Netherlands
Pfizer Investigational Site
Bydgoszcz, , Poland
Pfizer Investigational Site
Lodz, , Poland
Pfizer Investigational Site
Wroclaw, , Poland
Pfizer Investigational Site
Bratislava, Slovakia, Slovakia
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Nitra, , Slovakia
Pfizer Investigational Site
Overport, Durban, South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa
Pfizer Investigational Site
Durban, KwaZulu-Natal, South Africa
Pfizer Investigational Site
Claremont, Western Cape, South Africa
Pfizer Investigational Site
Durbanville, Western Cape, South Africa
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Majadahonda, Madrid, Spain
Pfizer Investigational Site
Umeå, , Sweden
Pfizer Investigational Site
Vaxjo, , Sweden
Pfizer Investigational Site
Bristol, , United Kingdom
Pfizer Investigational Site
Glasgow, , United Kingdom
Pfizer Investigational Site
Glasgow, , United Kingdom
Pfizer Investigational Site
Manchester, , United Kingdom
Countries
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References
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Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
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.
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.
Loftus EV, Baumgart DC, Gecse K, Kinnucan JA, Connelly SB, Salese L, Su C, Kwok KK, Woolcott JC, Armuzzi A. Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program. Inflamm Bowel Dis. 2023 May 2;29(5):744-751. doi: 10.1093/ibd/izac139.
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.
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.
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.
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.
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.
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.
Sandborn WJ, Panes J, Zhang H, Yu D, Niezychowski W, Su C. Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial. Gastroenterology. 2016 Jan;150(1):96-102. doi: 10.1053/j.gastro.2015.09.001. Epub 2015 Sep 12.
Panes J, Su C, Bushmakin AG, Cappelleri JC, Mamolo C, Healey P. Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. BMC Gastroenterol. 2015 Feb 5;15:14. doi: 10.1186/s12876-015-0239-9.
Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.
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Other Identifiers
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A3921063
Identifier Type: -
Identifier Source: org_study_id
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