Baricitinib vs TNF Inhibitors for Rheumatoid Arthritis

(RA-BRIDGE Trial)

Recruiting at 411 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Eli Lilly and Company

Must be taking: DMARDs

Disqualifiers: Cancer, Serious infection, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 5.5 years

2600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

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

Research shows that Baricitinib, an oral medication, is effective in improving symptoms and slowing joint damage in patients with rheumatoid arthritis who did not respond well to other treatments. It has been shown to work quickly and is generally well tolerated, providing a new option for those who have not had success with other drugs. ^{1 2 3 4 5}

Is baricitinib safe for humans?

Baricitinib is generally considered safe for humans, but there are some safety concerns, such as the risk of blood clots (thromboembolism), serious infections, and other rare but severe side effects like heart and liver issues. The 2 mg dose is approved due to these safety concerns, and it should be used cautiously, especially in patients who have not responded to other treatments. ^{1 2 6 7 8}

How does the drug baricitinib differ from TNF inhibitors for rheumatoid arthritis?

Baricitinib is unique because it is an oral medication that works by inhibiting specific enzymes called Janus Kinases (JAK1 and JAK2), which are involved in the immune response, whereas TNF inhibitors are typically injected and target a different part of the immune system. Baricitinib is often used when patients do not respond well to TNF inhibitors. ^{1 2 6 9 10}

What is the purpose of this trial?

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.

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 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.

Inclusion Criteria

I am 60 years old or older.

I have not responded well or am intolerant to at least one arthritis medication.

I am between 50 and 59 years old with a BMI between 25 and 29.9.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either baricitinib or a TNF inhibitor 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
• TNF Inhibitor

Trial Overview 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.

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.

Baricitinib is already approved in United States, European Union for the following indications:

Approved in United States as Olumiant for:

• Rheumatoid arthritis
• Severe alopecia areata
• COVID-19

Approved in European Union as Olumiant for:

• Rheumatoid arthritis
• Severe alopecia areata
• COVID-19

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

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 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, 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]

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 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]

In a study of 179 rheumatoid arthritis patients treated with either baricitinib (BARI) or tofacitinib (TOFA), both medications showed similar efficacy and safety profiles, with no significant difference in achieving low disease activity (LDA).

Baricitinib was found to be more effective in reducing pain compared to tofacitinib, indicating that while both treatments are effective, BARI may offer additional benefits in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of different Janus kinase inhibitors combined with methotrexate for the treatment of rheumatoid arthritis: a single-center randomized trial. Liao, X., Huo, W., Zeng, W., et al.[2023]

References

1. 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]

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

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

3. Spain pubmed.ncbi.nlm.nih.gov

Baricitinib: JAK inhibition for rheumatoid arthritis. [2021]

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

Comparative Effectiveness of First-Line Baricitinib in Patients With Rheumatoid Arthritis in the Australian OPAL Data Set. [2023]

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

Baricitinib: A Review in Rheumatoid Arthritis. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

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

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

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

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

Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of different Janus kinase inhibitors combined with methotrexate for the treatment of rheumatoid arthritis: a single-center randomized trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tofacitinib versus baricitinib in patients with rheumatoid arthritis in real clinical practice: analyses with propensity score-based inverse probability of treatment weighting. [2021]