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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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial compares the safety of two treatments for rheumatoid arthritis, focusing on the risk of blood clots. One treatment is baricitinib, an oral medication used for moderate to severe cases.
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.
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.
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.
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.
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
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 moreSide effects data
From 2015 Phase 3 trial • 1307 Patients • NCT017103586%
Nasopharyngitis
3%
Upper respiratory tract infection
3%
Bronchitis
2%
Influenza
2%
Back pain
2%
Urinary tract infection
1%
Pharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
BaricitinibTreatment B
Baricitinib Follow-up
Adalimumab Treatment B
Placebo Follow-up
Placebo Treatment B
Adalimumab Follow-up
Baricitinib Treatment A
Adalimumab Treatment A
Placebo Treatment A
Rescue
Awards & Highlights
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.
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
2,679 Previous Clinical Trials
3,465,029 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
15,878 Patients Enrolled for Rheumatoid Arthritis
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
62,666 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
2,886 Patients Enrolled for Rheumatoid Arthritis
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
426,979 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