A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
NCT ID: NCT02281552
Last Updated: 2018-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
209 participants
INTERVENTIONAL
2014-11-18
2017-03-15
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
DOUBLE
Study Groups
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tofacitinib modified release tablet
Tofacitinib
tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks
tofacitinib immediate release tablet
Tofacitinib
tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks
Interventions
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Tofacitinib
tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks
Tofacitinib
tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* currently taking a stable dose of methotrexate
* no evidence of active or latent or inadequately treated tuberculosis
Exclusion Criteria
* clinically significant infections within the past 6 months
20 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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Japanese Red Cross Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
National Hospital Organization Toyohashi Medical Center
Toyohashi, Aichi-ken, Japan
Yamada Rheumatology Clinic
Matsuyama, Ehime, Japan
St. Mary's Hospital
Kurume, Fukuoka, Japan
Gunma Rheumatism Clinic
Takasaki-shi, Gunma, Japan
Inoue Hospital
Tohrimachi, Takasaki, Gunma, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan
Katayama Orthopaedic Rheumatology Clinic
Asahikawa, Hokkaido, Japan
Yoshida orthopaedics and rheumatologyclinic
Morioka, Iwate, Japan
Komagamine Rheumatoid Orthopaedic Clinic
Morioka, Iwate, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan
Osaki Citizen Hospital
Oosaki, Miyagi, Japan
Tohoku University Hospital/ Department of Hematology and Rheumatology
Sendai, Miyagi, Japan
Nagano Red Cross Hospital
Nagano, Nagano, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, Japan
National Hospital Organization Ureshino Medical Center
Ureshino-shi, Saga-ken, Japan
Soshigayaokura clinic
Setagaya-ku, Tokyo, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, Japan
Honjo Rheumatism Clinic
Takaoka-shi, Toyama, Japan
Miyasato Clinic
Shūnan, Yamaguchi, Japan
National Hospital Organization Chiba-East Hospital
Chiba, , Japan
Sugimoto rheumatology and internal medicine clinic
Fukui, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
SHONO Rheumatism Clinic
Fukuoka, , Japan
Sagawa Akira Rheumatology Clinic
Hokkaido, , Japan
Matsubara Mayflower Hospital
Hyōgo, , Japan
Yokohama Minami Kyosai Hospital
Kanagawa, , Japan
Kumamoto Orthopaedic Hospital
Kumamoto, , Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, , Japan
Oribe Clinic of Rheumatology and Internal Medicine
Ōita, , Japan
Otsuka Clinic of Rheumatism and Medicine
Ōita, , Japan
Rabbit Clinic
Saitama, , Japan
Hirose Clinic
Saitama, , Japan
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.
Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
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.
Tanaka Y, Sugiyama N, Toyoizumi S, Lukic T, Lamba M, Zhang R, Chen C, Stock T, Valdez H, Mojcik C, Fan H, Deng C, Yuasa H. Modified- versus immediate-release tofacitinib in Japanese rheumatoid arthritis patients: a randomized, phase III, non-inferiority study. Rheumatology (Oxford). 2019 Jan 1;58(1):70-79. doi: 10.1093/rheumatology/key250.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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TOFACITINIB QD P3
Identifier Type: OTHER
Identifier Source: secondary_id
A3921215
Identifier Type: -
Identifier Source: org_study_id
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