Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
NCT01932372 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9968
Last updated 2024-10-26
Summary
The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.
1\) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2) Long-term safety (particularly, malignant tumors and serious infections) and efficacy
Occurrences of malignant tumors and serious infections will be compared with a control group.
Conditions
Interventions
- DRUG
-
Tofacitinib (Xeljanz)
5 mg Tablet BID
- DRUG
-
Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Eligibility
- Min Age
- 0 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-26
- Primary Completion
- 2021-08-24
- Completion
- 2021-08-24
Countries
- Japan
Study Locations
More Related Trials
-
To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks
NCT05606107 ·Status: UNKNOWN ·Phase: PHASE4
-
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
NCT03868072 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
NCT02147587 ·Status: COMPLETED ·Phase: PHASE2
-
Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX
NCT03975790 ·Status: COMPLETED
-
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
NCT01362062 ·Status: COMPLETED
-
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
NCT00531817 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis
NCT05572567 ·Status: COMPLETED
-
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
NCT02281552 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
NCT03980483 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
NCT01617005 ·Status: COMPLETED
-
Examination of Efficacy and Safety of Baricitinib in RA Patients
NCT03755466 ·Status: RECRUITING ·Phase: PHASE2
-
TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
NCT04413617 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
NCT02092467 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
NCT02996500 ·Status: COMPLETED ·Phase: PHASE2
-
Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis
NCT02087696 ·Status: UNKNOWN ·Phase: PHASE4
-
An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
NCT01254331 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis
NCT00535782 ·Status: COMPLETED ·Phase: PHASE3
-
Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation
NCT03100253 ·Status: TERMINATED ·Phase: PHASE4
-
Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
NCT04079920 ·Status: COMPLETED
-
Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement
NCT04062695 ·Status: UNKNOWN ·Phase: PHASE2
-
A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
NCT00771251 ·Status: COMPLETED ·Phase: PHASE3
-
T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade
NCT01060098 ·Status: COMPLETED
-
Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
NCT02097524 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
NCT01089023 ·Status: COMPLETED ·Phase: PHASE4
-
An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy
NCT03155347 ·Status: COMPLETED ·Phase: PHASE3