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Janus Kinase (JAK) Inhibitor

Baricitinib vs TNF Inhibitors for Rheumatoid Arthritis (RA-BRIDGE Trial)

Phase 4
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 60 years of age
Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
Must not have
Participants must not have cancer.
Participants must not have had more than one VTE.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (approximately 5.5 years)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the safety of baricitinib to TNF inhibitors with respect to VTEs in patients with RA.

Who is the study for?
This trial is for adults with rheumatoid arthritis who are overweight or older, have had a poor response to previous treatments, and may have had a blood clot before. It's not for those with recent drug abuse, pregnancy, multiple blood clots, cancer, serious infections or illnesses, recent live vaccines, or participation in another trial within the last month.
What is being tested?
The study compares Baricitinib against TNF inhibitors regarding the risk of venous thromboembolic events (blood clots) in patients with rheumatoid arthritis. The goal is to determine which treatment has fewer complications related to blood clots.
What are the potential side effects?
Baricitinib and TNF inhibitors can cause side effects like increased risk of infection due to immune system suppression. There might also be risks specific to each medication such as allergic reactions or other adverse effects that will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I have not responded well or am intolerant to at least one arthritis medication.
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I am between 50 and 59 years old with a BMI between 25 and 29.9.
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I am either over 30 BMI, or aged 50-59 with a BMI of 25-29.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have cancer.
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I have had one or no blood clots.
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I do not have any serious infections or illnesses like active herpes, tuberculosis, or similar.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion (approximately 5.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion (approximately 5.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Secondary study objectives
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
+2 more

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
5%
Nasopharyngitis
3%
Pharyngitis
2%
Urinary tract infection
2%
Bronchitis
1%
Back pain
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab Treatment B
BaricitinibTreatment B
Baricitinib Follow-up
Placebo Follow-up
Placebo Treatment B
Adalimumab Follow-up
Baricitinib Treatment A
Adalimumab Treatment A
Placebo Treatment A
Rescue

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Baricitinib Low DoseExperimental Treatment1 Intervention
Baricitinib administered orally.
Group II: Baricitinib High DoseExperimental Treatment1 Intervention
Baricitinib administered orally.
Group III: TNF InhibitorActive Control1 Intervention
Adalimumab or etanercept administered subcutaneously (SC) per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,667 Previous Clinical Trials
3,225,877 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
14,578 Patients Enrolled for Rheumatoid Arthritis
Incyte CorporationIndustry Sponsor
391 Previous Clinical Trials
61,324 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
1,586 Patients Enrolled for Rheumatoid Arthritis
Study DirectorEli Lilly and Company
1,383 Previous Clinical Trials
423,541 Total Patients Enrolled
17 Trials studying Rheumatoid Arthritis
10,943 Patients Enrolled for Rheumatoid Arthritis

Media Library

Baricitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03915964 — Phase 4
Rheumatoid Arthritis Research Study Groups: Baricitinib Low Dose, Baricitinib High Dose, TNF Inhibitor
Rheumatoid Arthritis Clinical Trial 2023: Baricitinib Highlights & Side Effects. Trial Name: NCT03915964 — Phase 4
Baricitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915964 — Phase 4
~183 spots leftby Apr 2025
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