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Janus Kinase (JAK) Inhibitor
Baricitinib for Rheumatoid Arthritis (RA-BRANCH Trial)
Phase 4
Recruiting
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
Documented evidence of a VTE prior to this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (approximately 5.5 years)
Awards & highlights
RA-BRANCH Trial Summary
This trial will compare the safety of baricitinib to other drugs used to treat rheumatoid arthritis with respect to the risk of developing blood clots.
Who is the study for?
This trial is for people over 60 with rheumatoid arthritis who've had a blood clot (VTE) and are overweight (BMI ≥30 kg/m²). It's not for those with cancer, previous JAK inhibitor use, or more than one TNF inhibitor treatment. Participants should have tried at least one RA medication without success.Check my eligibility
What is being tested?
The study compares the safety of Baricitinib, a drug targeting immune response, to TNF inhibitors in preventing blood clots in patients with rheumatoid arthritis. The goal is to see which treatment has fewer risks associated with VTEs.See study design
What are the potential side effects?
Baricitinib may cause side effects like infections, high cholesterol levels, liver enzyme elevations, and possibly increase the risk of developing blood clots. TNF inhibitors can lead to infections and reactions at the injection site.
RA-BRANCH 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...
You have a BMI of 30 or higher.
RA-BRANCH 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 moreRA-BRANCH 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
2,619 Previous Clinical Trials
3,205,299 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
15,878 Patients Enrolled for Rheumatoid Arthritis
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
53,889 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
2,886 Patients Enrolled for Rheumatoid Arthritis
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
404,445 Total Patients Enrolled
17 Trials studying Rheumatoid Arthritis
12,243 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a BMI of 30 or higher.I have not responded well or am intolerant to at least one arthritis medication.I have not responded well or am intolerant to at least one arthritis medication.I do not have cancer.I am 60 years old or older.I have not used a JAK inhibitor or more than one TNF inhibitor.To be eligible for the study, you need to have at least one of the following characteristics:I am between 50 and 59 years old with a BMI of 25 to just under 30.I am 60 years old or older.I am either over 30 BMI, or aged 50-59 with a BMI of 25-29.
Research Study Groups:
This trial has the following groups:- Group 1: Baricitinib High Dose
- Group 2: TNF Inhibitor
- Group 3: Baricitinib Low Dose
Awards:
This trial has 3 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT04086745 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any former experiments utilized Baricitinib?
"At present, 96 studies of Baricitinib are active with 34 trials in their 3rd Phase. Although a large number of them take place in London, City Of, this medication is being tested around the world at 3216 sites."
Answered by AI
What medical conditions are typically treated with Baricitinib?
"Baricitinib is a viable treatment option for polyarticular juvenile idiopathic arthritis, phototherapy, and in-patient care."
Answered by AI
How many sites are offering access to this experiment?
"This medical trial is currently being conducted at 100 clinics, including ones in Mesquite, Amarillo and Hagerstown. For the most convenient experience possible when signing up for this study, it's recommended that you select a clinic nearest to your location."
Answered by AI
How many participants are partaking in this medical experiment?
"This venture necessitates the recruitment of 1300 people that meet all eligibility criteria. Eli Lilly and Company are running this trial, with Southwest Rheumatology, P.A in Mesquite, Texas and Amarillo Center for Clinical Research situated in Maryland among their sites of operation."
Answered by AI
Have any recruitment efforts been initiated for this research endeavor?
"Absolutely. Clinicaltrials.gov has evidence that this clinical trial, initially released on February 14th 2020, is searching for volunteers now. The study calls for 1300 patients to be recruited from 100 separate medical sites."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New Jersey
Other
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Arizona Arthritis & Rheumatology Research
Clinical Research Philadelphia, LLC
Clinical Research of Philadelphia
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
3+
What questions have other patients asked about this trial?
How long does the screening take?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I tried drugs they don’t work. Nothing else has worked for me. I had plantar fasciitis surgery.
PatientReceived no prior treatments
What to know more about arthritis. Well I'm tired of pain all the time.
PatientReceived no prior treatments
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