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.
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.
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
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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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