Recruiting

A Study of Baricitinib in Participants With Rheumatoid Arthritis

I4V-MC-JAJD - ClinicalTrials.gov - NCT04086745

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).
How long will I be in the trial?
Your participation in this trial could last up to 5 years.
Email
Recruiting

A Study of Baricitinib in Participants With Rheumatoid Arthritis

I4V-MC-JAJD - ClinicalTrials.gov - NCT04086745

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).
How long will I be in the trial?
Your participation in this trial could last up to 5 years.
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

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)

Participants must NOT

Participant must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was: - Discontinued for IR (lack or loss of efficacy) for RA, or - Discontinued for intolerance (AE) when used for any indication

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

Trial Summary

Conditions the trial is for

Rheumatoid Arthritis

What the trial is testing?

Baricitinib, TNF Inhibitor

Could I receive a Placebo?

no

Enrollment Goal

1300

Trial Dates

February 2020 - December 2024

Trial Phase

4

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

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)

Participants must NOT

Participant must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was: - Discontinued for IR (lack or loss of efficacy) for RA, or - Discontinued for intolerance (AE) when used for any indication

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

Trial Summary

Conditions the trial is for

Rheumatoid Arthritis

What the trial is testing?

Baricitinib, TNF Inhibitor

Could I receive a Placebo?

no

Enrollment Goal

1300

Trial Dates

February 2020 - December 2024

Trial Phase

4

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Trial Locations

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Rheumatoid Arthritis Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?