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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (approximately 5.5 years)
Awards & highlights
RA-BRIDGE 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.Check my eligibility
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.See study design
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.
RA-BRIDGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I have not responded well or am intolerant to at least one arthritis medication.
Select...
I am between 50 and 59 years old with a BMI between 25 and 29.9.
Select...
I am either over 30 BMI, or aged 50-59 with a BMI of 25-29.
RA-BRIDGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion (approximately 5.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion (approximately 5.5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Secondary outcome measures
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 moreSide effects data
From 2015 Phase 3 trial • 1307 Patients • NCT0171035810%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Headache
4%
Pharyngitis
3%
Alanine aminotransferase increased
3%
Back pain
3%
Erectile dysfunction
3%
Nausea
3%
Hypertension
2%
Diarrhoea
2%
Cough
2%
Dyspepsia
2%
Bronchitis
2%
Influenza
2%
Rash
1%
Hypercholesterolaemia
1%
Hyperlipidaemia
1%
Rheumatoid arthritis
1%
Anaemia
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab Treatment A
Placebo Treatment B
Adalimumab Treatment B
Baricitinib Follow-up
Placebo Follow-up
BaricitinibTreatment B
Baricitinib Treatment A
Adalimumab Follow-up
Placebo Treatment A
Rescue
RA-BRIDGE 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
2,613 Previous Clinical Trials
3,198,329 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
14,578 Patients Enrolled for Rheumatoid Arthritis
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
52,565 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
1,586 Patients Enrolled for Rheumatoid Arthritis
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
402,652 Total Patients Enrolled
17 Trials studying Rheumatoid Arthritis
10,943 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 years old or older.I have not responded well or am intolerant to at least one arthritis medication.I do not have cancer.You have not used illegal drugs, injected drugs, or abused alcohol regularly in the past year.I have not received a live vaccine in the last four weeks.I am between 50 and 59 years old with a BMI between 25 and 29.9.I have had one or no blood clots.I do not have any serious infections or illnesses like active herpes, tuberculosis, or similar.I am either over 30 BMI, or aged 50-59 with a BMI of 25-29.You need to have at least one of the following traits:I have no medical reasons preventing me from taking TNF inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Baricitinib Low Dose
- Group 2: Baricitinib High Dose
- Group 3: TNF Inhibitor
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants currently being accepted into this experiment?
"As of right now, this clinical trial has completed recruitment for participants. This particular study was first posted on April 25th, 2019 and most recently updated on June 20th, 2022. There are other active trials though: 399 studies related to rheumatoid arthritis and 101 involving Baricitinib specifically are still admitting patients."
Answered by AI
Could you tell me if there is any other research that has been conducted on Baricitinib?
"There are currently one hundred and one clinical trials for Baricitinib that have not yet concluded, with thirty-six of them in Phase 3. Most of these studies are based in London, but there are 3240 total locations where clinical trials for Baricitinib are taking place."
Answered by AI
Are there any other research institutions conducting this investigation in our state?
"In total, this clinical trial has 84 locations with the Pennsylvania Regional Center for Arthritis and Osteoporosis Research in Wyomissing, Pennsylvania, Cincinnati Rheumatic Disease Study Group in Cincinnati, Ohio, and Center for Arthritis and Osteoporosis in Elizabethtown, Kentucky being some of them."
Answered by AI
What is the total number of patients that will be participating in this research?
"The trial wrapped up recruitment and is no longer looking for participants. The listing was first created on April 25th, 2019 and updated June 20th, 2022. However, there are many other similar trials that may be of interest. There are 399 ongoing clinical studies involving rheumatoid arthritis patients and 101 active trials using Baricitinib recruiting right now."
Answered by AI
Has the FDA cleared Baricitinib for patient use?
"Baricitinib has been approved, so it receives a score of 3 for safety."
Answered by AI
What are the primary conditions that Baricitinib has been proven to ameliorate?
"Baricitinib, while typically used to treat hospitalized patients, can also be effective for treating conditions like polyarticular juvenile idiopathic arthritis, phototherapy, and coronavirus disease 2019 (covid‑19)."
Answered by AI
Who else is applying?
What site did they apply to?
Arizona Arthritis & Rheumatology Research, PLLC
East Penn Rheumatology Associates
What portion of applicants met pre-screening criteria?
Met criteria
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