A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (NCT03915964) | Clinical Trial Compass
CompletedPhase 4
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
United States, Australia, Austria2,659 participantsStarted 2019-04-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 drug (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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)