This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,317
Administered orally.
Administered SC
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Time from First Dose of Study Treatment to First Event of VTE
Time frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
Time from First Dose of Study Treatment to First ATE
Time frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
Time from First Dose of Study Treatment to First MACE
Time frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
Time from First Dose of Study Treatment to First Malignancy (excluding NMSC)
Time frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Opportunistic Infection
Time from First Dose of Study Treatment to First Opportunistic Infection
Time frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Serious Infection
Time from First Dose of Study Treatment to First Serious Infection
Time frame: Baseline through Study Completion (Approximately 5.5 Years)
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Arizona Research Clinic PLLC
Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research
Paradise Valley, Arizona, United States
Sun Valley Arthritis Center, LTD
Peoria, Arizona, United States
Arizona Arthritis & Rheumatology Associates
Phoenix, Arizona, United States
Arthritis and Rheumatism Associates
Jonesboro, Arkansas, United States
Providence St. Joseph's Medical Center
Burbank, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Medvin Clinical Research - Covina
Covina, California, United States
TriWest Research Associates LLC
El Cajon, California, United States
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