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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 below
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I am 60 years old or older.
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You have a BMI of 30 or higher.

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

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
2,670 Previous Clinical Trials
3,227,469 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
15,878 Patients Enrolled for Rheumatoid Arthritis
Incyte CorporationIndustry Sponsor
391 Previous Clinical Trials
62,525 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
2,886 Patients Enrolled for Rheumatoid Arthritis
Study DirectorEli Lilly and Company
1,385 Previous Clinical Trials
425,091 Total Patients Enrolled
17 Trials studying Rheumatoid Arthritis
12,243 Patients Enrolled for Rheumatoid Arthritis

Media Library

Baricitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04086745 — Phase 4
Rheumatoid Arthritis Research Study Groups: Baricitinib High Dose, TNF Inhibitor, Baricitinib Low Dose
Rheumatoid Arthritis Clinical Trial 2023: Baricitinib Highlights & Side Effects. Trial Name: NCT04086745 — Phase 4
Baricitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04086745 — Phase 4
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT04086745 — Phase 4
~22 spots leftby Dec 2024
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