Baricitinib for Rheumatoid Arthritis

(RA-BRANCH Trial)

Recruiting at 162 trial locations

Overseen By Alan Kivitz

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Eli Lilly and Company

Must be taking: DMARDs

Must not be taking: JAK inhibitors

Disqualifiers: Cancer, Active tuberculosis, Serious infection, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you must not have used a Janus kinase (JAK) inhibitor before or more than one TNF inhibitor that was stopped due to lack of effectiveness or intolerance.

What data supports the effectiveness of the drug Baricitinib for treating rheumatoid arthritis?

Research shows that Baricitinib, an oral medication, effectively reduces symptoms and slows joint damage in patients with rheumatoid arthritis who haven't responded well to other treatments. It works by targeting specific enzymes involved in the disease process, and studies have demonstrated its benefits in improving physical function and reducing disease activity. ^{1 2 3 4 5}

Is Baricitinib safe for humans?

Baricitinib is generally considered safe for humans, but there are some safety concerns, especially with the higher 4 mg dose, which is linked to an increased risk of blood clots. The approved 2 mg dose has an acceptable safety profile, though rare serious side effects like infections and heart or liver issues have been observed. ^{1 3 5 6 7}

How is the drug Baricitinib different from other treatments for rheumatoid arthritis?

Baricitinib is unique because it is an oral medication that works by inhibiting specific enzymes called JAK1 and JAK2, which are involved in the immune response, making it different from other treatments like TNF inhibitors that target different pathways. It is particularly useful for patients who have not responded well to other treatments, and it has shown effectiveness in reducing joint damage and inflammation. ^{1 3 4 7 8}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

You have a BMI of 30 or higher.

I am 60 years old or older.

Documented evidence of a VTE prior to this study

Exclusion Criteria

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either baricitinib or TNF inhibitors to compare safety with respect to venous thromboembolic events

Approximately 5.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Baricitinib (Janus Kinase (JAK) Inhibitor)
• TNF Inhibitor (TNF Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Baricitinib Low Dose Experimental Treatment 1 Intervention

Baricitinib administered orally.

Group II: Baricitinib High Dose Experimental Treatment 1 Intervention

Baricitinib administered orally.

Group III: TNF Inhibitor Active Control 1 Intervention

Adalimumab or etanercept administered subcutaneously (SC) per standard of care.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

Baricitinib is an effective oral treatment for rheumatoid arthritis (RA), particularly in patients who have not responded to other therapies, showing efficacy in four clinical trials and delaying radiographic progression of the disease.

While the 4 mg dose of baricitinib demonstrated greater efficacy, only the 2 mg dose is FDA approved due to safety concerns, particularly the risk of thromboembolism, highlighting the importance of weighing safety and effectiveness when prescribing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib: The Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis. Mogul, A., Corsi, K., McAuliffe, L.[2021]

Baricitinib is an effective oral treatment for moderate to severe rheumatoid arthritis (RA), showing significant improvements in symptoms, disease activity, and physical function in patients who did not respond well to other DMARDs, based on pivotal trials involving multiple countries.

The treatment was generally well tolerated over a duration of up to 5.5 years, with common side effects including upper respiratory infections and increased LDL cholesterol, making it a viable option for patients with limited treatment alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib: A Review in Rheumatoid Arthritis. Al-Salama, ZT., Scott, LJ.[2021]

In a double-blind phase III study involving 527 patients with moderately to severely active rheumatoid arthritis who had not responded to previous treatments, baricitinib significantly improved patient-reported outcomes (PROs) compared to placebo over 24 weeks.

Patients receiving the higher dose of baricitinib (4 mg) experienced more rapid and greater improvements in physical functioning, fatigue, pain, and morning joint stiffness, indicating its efficacy as a treatment option for those with treatment-refractory rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Smolen, JS., Kremer, JM., Gaich, CL., et al.[2021]

Baricitinib, a selective JAK1/JAK2 inhibitor, has demonstrated significant clinical efficacy in patients with rheumatoid arthritis (RA) who did not respond adequately to conventional and biological DMARDs, showing improvements in radiographic joint damage in pivotal phase III trials.

The drug was well tolerated with no unexpected safety issues reported, and a long-term phase III study is currently assessing its safety and efficacy over four years, indicating ongoing commitment to understanding its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib: JAK inhibition for rheumatoid arthritis. Gras, J.[2021]

In a two-year study of 44 patients with rheumatoid arthritis, both baricitinib and tofacitinib were found to be effective in reducing disease activity, with baricitinib showing slightly greater reductions in the DAS28 scale and pain levels over 12 months.

Both medications had similar safety profiles, with low rates of adverse reactions (10% for baricitinib and 12.5% for tofacitinib) and comparable treatment discontinuation rates due to loss of effectiveness, indicating they are both viable options for managing rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib and tofacitinib in patients with rheumatoid arthritis: results of regular clinical practice. González-Freire, L., Giménez-Candela, RM., Castro-Luaces, S., et al.[2021]

Baricitinib is an effective treatment for moderately to severely active rheumatoid arthritis (RA), showing significant benefits over placebo, methotrexate, and adalimumab in improving symptoms and quality of life, as demonstrated in Phase III randomized controlled trials.

While baricitinib has an acceptable safety profile, it is associated with some rare but serious adverse events, including infections and malignancies, making monitoring necessary during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New alternative in the treatment of rheumatoid arthritis: clinical utility of baricitinib. Kawalec, P., Śladowska, K., Malinowska-Lipień, I., et al.[2020]

Baricitinib demonstrated a consistent safety profile over 128 weeks in patients with rheumatoid arthritis, with treatment-emergent adverse events occurring in 63% of patients on 4 mg and 67% on 8 mg, and no unexpected late safety signals identified.

Clinical improvements in disease symptoms were maintained beyond the initial 24-week blinded period, with similar or increased rates of disease improvement observed at weeks 76 and 128, indicating the long-term efficacy of baricitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. Keystone, EC., Genovese, MC., Schlichting, DE., et al.[2021]

Baricitinib has shown real-world effectiveness in treating moderate-to-severe rheumatoid arthritis, with 8.7-60% of patients achieving remission within 12 weeks and 20.2-81.6% reaching low disease activity by 24 weeks, indicating its efficacy across various patient backgrounds.

The safety profile of baricitinib remains consistent with previous clinical studies, and it demonstrates high drug persistence rates comparable to anti-tumor necrosis factor drugs, suggesting it is a reliable treatment option for patients with rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis. Hernández-Cruz, B., Kiltz, U., Avouac, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Baricitinib: The Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Baricitinib: A Review in Rheumatoid Arthritis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Baricitinib: JAK inhibition for rheumatoid arthritis. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

Baricitinib and tofacitinib in patients with rheumatoid arthritis: results of regular clinical practice. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

New alternative in the treatment of rheumatoid arthritis: clinical utility of baricitinib. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis. [2023]