A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Baricitinib
* Drug: TNF Inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have at least one of the following characteristics: Documented evidence of a VTE prior to this study At least 60 years of age A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or Age 50 to less than 60 years and BMI 25 to less than 30 kg/m². Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic). Exclusion Criteria: Participant should have no reason to not take a TNF inhibitor. Participants must not be pregnant or breastfeeding. Participants must not have had more than one VTE. Participants must not have cancer. Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness. Participants must not have had a live vaccine within four weeks of study start. Participants must not have participated in any other clinical trial within four weeks of study start. Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricitinib Low Dose<br>Baricitinib administered orally. | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;|
| Experimental: Baricitinib High Dose<br>Baricitinib administered orally. | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;|
| Active Comparator: TNF Inhibitor<br>Adalimumab or etanercept administered subcutaneously (SC) per standard of care. | Drug: TNF Inhibitor<br>* Administered SC<br>* Other names: Adalimumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline through Study Completion (Approximately 5.5 Years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) | Time from First Dose of Study Treatment to First ATE | 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 | 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) | 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 | 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 | Baseline through Study Completion (Approximately 5.5 Years) |