Baricitinib vs TNF Inhibitors for Rheumatoid Arthritis

(RA-BRIDGE Trial)

No longer recruiting at 466 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for rheumatoid arthritis: baricitinib, a Janus kinase inhibitor, and TNF inhibitors, a class of biologic drugs. Researchers aim to determine which treatment is safer by specifically examining blood clot issues known as venous thromboembolic events (VTEs). The trial suits individuals with rheumatoid arthritis who have struggled with other treatments and meet certain health conditions, such as being over 60 or having a higher body weight. Participants should have no more than one past VTE and must not have certain serious health issues. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

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 is the safety track record for baricitinib and TNF inhibitors?

Research has shown that baricitinib is generally safe, similar to other treatments in its group, such as JAK inhibitors and biologics. Studies have found that people can take baricitinib safely for many years, even up to nine years. However, people with rheumatoid arthritis face a higher risk of infections.

TNF inhibitors, such as adalimumab and etanercept, also have a strong safety record. These medications have been used for a long time to treat rheumatoid arthritis and are usually well-tolerated. However, like many treatments that affect the immune system, they carry a risk of infections.

Both baricitinib and TNF inhibitors have received FDA approval for treating rheumatoid arthritis, indicating they have passed strict safety tests. Always consult a doctor if there are any concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Baricitinib is unique because it targets a different pathway than typical rheumatoid arthritis treatments. Most standard therapies, like TNF inhibitors (e.g., adalimumab and etanercept), focus on blocking tumor necrosis factor to reduce inflammation. In contrast, Baricitinib works by inhibiting Janus kinase (JAK) enzymes, which play a crucial role in the immune response. This different mechanism may offer hope for patients who don't respond well to TNF inhibitors, providing an alternative way to manage their symptoms. Researchers are excited about Baricitinib's potential to offer more personalized treatment options for those with rheumatoid arthritis.

What evidence suggests that this trial's treatments could be effective for rheumatoid arthritis?

This trial will compare Baricitinib with TNF inhibitors for treating rheumatoid arthritis. Research has shown that Baricitinib, which participants may receive in either a low or high dose, effectively treats rheumatoid arthritis. Studies indicate that taking Baricitinib helps maintain low symptoms or even eliminates them for over six years. Specifically, after 12 weeks, 20% of patients taking 2 mg of Baricitinib with other treatments experienced significant symptom relief, compared to only 8% who took a placebo. TNF inhibitors, such as adalimumab and etanercept, are another treatment option in this trial and are also proven treatments for rheumatoid arthritis. Both Baricitinib and TNF inhibitors have successfully controlled symptoms and improved the quality of life for people with this condition. ^{3 4 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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, 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38258434/

Efficacy of baricitinib in patients with moderate-to-severe ... Conclusion: Treatment with baricitinib 4 mg or 2 mg demonstrated efficacy up to 6.5 years with maintained LDA/remission results across SDAI, ...

2. academic.oup.com academic.oup.com/rheumatology/article/63/10/2799/7585442

Efficacy of baricitinib in patients with moderate-to-severe ... Treatment with baricitinib 4 mg or 2 mg demonstrated efficacy up to 6.5 years with maintained LDA/remission results across SDAI, CDAI and DAS28-hsCRP.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02265705

NCT02265705 | A Study of Baricitinib (LY3009104) in ... The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as baricitinib in participants with moderately to ...

4. olumiant.lilly.com olumiant.lilly.com/hcp/rheumatoid-arthritis

Rheumatoid Arthritis | HCP | Olumiant® (baricitinib) - Eli Lilly At week 12, 20% of patients taking Olumiant 2 mg/day plus cDMARDs achieved an ACR50 response compared to 8% of patients taking placebo plus cDMARDs, with a p- ...

5. jrheum.org jrheum.org/content/52/4/316

Baricitinib Dose Reduction in Patients With Rheumatoid ... Efficacy. Among those who achieved sustained disease control with baricitinib 4 mg, most patients, ranging from 60% to 91%, retained a state of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9443639/

A Review of Safety Outcomes from Clinical Trials ... Patients with RA, AD and SLE have an increased risk for infections compared with those without the disease or the general population, with the ...

7. ard.bmj.com ard.bmj.com/content/81/3/335

Safety of baricitinib for the treatment of rheumatoid arthritis ... The results suggest that baricitinib has a consistent safety profile as demonstrated in previous reports and is in line with other JAK inhibitors and biologic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12450180/

The RA-BE-REAL Study Long-term extension studies have shown sustained efficacy up to 7 years and safety up to 9 years [19–21]. Its long-term safety has also been ...