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Last Updated: October 18, 2021

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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.
New Indication NCT04925973 ↗ Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management Recruiting McMaster 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.
>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 Active, not recruiting Pfizer Phase 3 2007-02-01 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 N/A 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.
NCT01465763 ↗ A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis Completed Pfizer Phase 3 2012-04-01 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.
NCT01484561 ↗ A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis Completed Pfizer Phase 1 2012-04-01 The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).
NCT01499004 ↗ A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers Completed Pfizer Phase 1 2011-11-01 This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tofacitinib

Condition Name

Condition Name for Tofacitinib
Intervention Trials
Rheumatoid Arthritis 19
Healthy 11
Psoriatic Arthritis 7
Arthritis, Rheumatoid 6
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Condition MeSH

Condition MeSH for Tofacitinib
Intervention Trials
Arthritis 37
Arthritis, Rheumatoid 24
Arthritis, Psoriatic 8
Colitis 8
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Clinical Trial Locations for Tofacitinib

Trials by Country

Trials by Country for Tofacitinib
Location Trials
United States 327
Mexico 45
Canada 41
Australia 37
Spain 33
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Trials by US State

Trials by US State for Tofacitinib
Location Trials
Florida 22
California 21
Texas 19
Pennsylvania 16
Ohio 14
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Clinical Trial Progress for Tofacitinib

Clinical Trial Phase

Clinical Trial Phase for Tofacitinib
Clinical Trial Phase Trials
Phase 4 16
Phase 3 23
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Tofacitinib
Clinical Trial Phase Trials
Not yet recruiting 38
Recruiting 32
Completed 23
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Clinical Trial Sponsors for Tofacitinib

Sponsor Name

Sponsor Name for Tofacitinib
Sponsor Trials
Pfizer 47
Yale University 4
Shanghai Zhongshan Hospital 3
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Sponsor Type

Sponsor Type for Tofacitinib
Sponsor Trials
Other 68
Industry 62
NIH 5
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