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Last Updated: February 7, 2023

CLINICAL TRIALS PROFILE FOR TOFACITINIB


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505(b)(2) Clinical Trials for Tofacitinib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT04925973 ↗ Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management Recruiting McGill University Phase 2 2021-06-01 The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib.
New Indication NCT04925973 ↗ Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management Recruiting University of Alberta Phase 2 2021-06-01 The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib.
New Indication NCT04925973 ↗ Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management Recruiting University of British Columbia Phase 2 2021-06-01 The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib.
New Indication NCT04925973 ↗ Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management Recruiting University of Manitoba Phase 2 2021-06-01 The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tofacitinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00413699 ↗ Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis Completed Pfizer Phase 3 2007-02-05 The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550 A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550
NCT01164579 ↗ Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA) Completed Pfizer Phase 2 2010-10-01 Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate na├»ve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.
NCT01375127 ↗ Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients Completed Pfizer 2011-08-01 This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.
NCT01458951 ↗ A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis Completed Pfizer Phase 3 2012-06-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tofacitinib

Condition Name

Condition Name for Tofacitinib
Intervention Trials
Rheumatoid Arthritis 26
Healthy 11
Psoriatic Arthritis 8
Ulcerative Colitis 7
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Condition MeSH

Condition MeSH for Tofacitinib
Intervention Trials
Arthritis 45
Arthritis, Rheumatoid 31
Colitis 10
Ulcer 9
[disabled in preview] 0
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Clinical Trial Locations for Tofacitinib

Trials by Country

Trials by Country for Tofacitinib
Location Trials
United States 450
China 79
Mexico 69
Canada 58
Australia 51
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Trials by US State

Trials by US State for Tofacitinib
Location Trials
California 27
Florida 27
Texas 23
Connecticut 20
Pennsylvania 20
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Clinical Trial Progress for Tofacitinib

Clinical Trial Phase

Clinical Trial Phase for Tofacitinib
Clinical Trial Phase Trials
Phase 4 22
Phase 3 25
Phase 2/Phase 3 1
[disabled in preview] 32
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Clinical Trial Status

Clinical Trial Status for Tofacitinib
Clinical Trial Phase Trials
Completed 54
Recruiting 33
Not yet recruiting 18
[disabled in preview] 7
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Clinical Trial Sponsors for Tofacitinib

Sponsor Name

Sponsor Name for Tofacitinib
Sponsor Trials
Pfizer 49
Yale University 4
Shanghai Zhongshan Hospital 4
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Sponsor Type

Sponsor Type for Tofacitinib
Sponsor Trials
Other 100
Industry 73
NIH 6
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