Baricitinib for Rheumatoid Arthritis
(RA-BRANCH Trial)
Recruiting in Palo Alto (17 mi)
+162 other locations
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.
12345Is 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.
13567How 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.
13478Eligibility 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.
+5 more
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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical Research Philadelphia, LLCPhiladelphia, PA
Arizona Research Clinic PLLCChandler, AZ
Arizona Arthritis & Rheumatology ResearchParadise Valley, AZ
Arizona Arthritis & Rheumatology AssociatesPhoenix, AZ
More Trial Locations
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Who Is Running the Clinical Trial?
Eli Lilly and CompanyLead Sponsor
Incyte CorporationIndustry Sponsor
References
Baricitinib: The Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis. [2021]Objective: To review the pharmacology, pharmacokinetics, safety, and efficacy of baricitinib, a recently approved selective Janus Kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA), and explore its potential role in therapy. Data Sources: Articles were identified using a PubMed search from inception through January 2019 using the terms rheumatoid arthritis, Olumiant, baricitinib, and LY3009104, its molecular name. Study Selection and Data Extraction: Articles relating to randomized clinical trials, pharmacology, pharmacokinetics, efficacy, and safety of baricitinib were evaluated. Data Synthesis: Baricitinib exerts its effects by inhibiting JAK1 and JAK2 enzymes, targeting cytokine and growth factor receptor stimulation, thus reducing downstream immune cell function. Four trials have demonstrated the efficacy of baricitinib with or without methotrexate in patients naïve to disease-modifying antirheumatic drugs (DMARDs) and those who had an inadequate response to or intolerance to both conventional and biological DMARDs. Furthermore, baricitinib was associated with delayed radiographic progression. Despite baricitinib 4 mg often demonstrating greater efficacy compared with the 2 mg dose, only the 2 mg dose is Food and Drug Administration approved because of safety concerns with the 4 mg dose, primarily thromboembolism. Relevance to Patient Care and Clinical Practice: Baricitinib provides an oral treatment option for patients failing tumor necrosis factor inhibitors (TNFis). Safety, cost, and comparative effectiveness to tofacitinib should be considered prior to prescribing baricitinib. Conclusion: Baricitinib is the second medication in its class and has been proven efficacious for the treatment of RA. Given concerns for adverse effects associated with baricitinib, it should be reserved for patients who have failed one or more TNFis.
Baricitinib: A Review in Rheumatoid Arthritis. [2021]Baricitinib (Olumiant®) is an oral, targeted synthetic DMARD that inhibits JAK1 and JAK2, which are implicated in the pathogenesis of rheumatoid arthritis (RA). This novel, small molecule is approved for use as monotherapy, or in combination with methotrexate, for the treatment of adults with moderate to severe active RA who responded inadequately to or were intolerant of ≥ 1 DMARD. In pivotal multinational trials, once-daily baricitinib 4 mg, with/without methotrexate (± another csDMARD), improved the signs and symptoms of RA, disease activity and physical function in DMARD-naive patients and in patients with an inadequate response to methotrexate, csDMARDs or TNF inhibitors; baricitinib treatment also slowed structural joint damage in DMARD-naive patients and in those with an inadequate response to methotrexate and csDMARDs. Baricitinib plus methotrexate was more effective than adalimumab plus methotrexate in patients with an inadequate response to methotrexate. The onset of these benefits was generally rapid and sustained over time. Baricitinib was generally well tolerated during up to 5.5 years' treatment; the most commonly reported adverse drug reactions were upper respiratory tract infections, increased LDL cholesterol, nausea and thrombocytosis. Thus, once-daily baricitinib, as monotherapy or in combination with methotrexate, is an effective and generally well tolerated emerging treatment for patients with moderate to severe active RA who have responded inadequately to or are intolerant of ≥ 1 DMARD, and extends the options available for this population.
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]To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).
Baricitinib: JAK inhibition for rheumatoid arthritis. [2021]Rheumatoid arthritis (RA), a chronic autoimmune inflammatory disease characterized by inflammation and joint destruction, is associated with pain, progressive disability, systemic comorbidities and early death. Conventional disease-modifying antirheumatic drugs (DMARDs) and biological DMARDs (bDMARDs) have been able to achieve remission or a very low disease activity status for RA. Nevertheless, since many patients do not reach a sufficient response with DMARDs or present with unacceptable side effects, new therapies are needed. Baricitinib (LY-3009104, INCB-028050), a new potent and selective tyrosine-protein kinase JAK1/JAK2 inhibitor, has shown clinical efficacy in patients with RA refractory to aggressive standard-of-care treatment (with both conventional DMARDs and bDMARDs) when administered orally at 4 mg q.d. in pivotal phase III clinical trials. In these studies, radiographic joint damage assessments showed significant improvements with baricitinib, and the drug was well tolerated with no unexpected safety findings. A phase III study aimed at assessing long-term (4 years) safety and efficacy of baricitinib is ongoing. Registration processes are ongoing in Europe, the U.S. and Japan.
Baricitinib and tofacitinib in patients with rheumatoid arthritis: results of regular clinical practice. [2021]Main objective: Describe the effectiveness and safety of baricitinib and tofacitinib in patients diagnosed with rheumatoid arthritis in our hospital.
New alternative in the treatment of rheumatoid arthritis: clinical utility of baricitinib. [2020]Baricitinib is an innovative small-molecule drug that reversibly inhibits continuous activation of JAK/STAT pathway, thus reducing joint inflammation. The drug was approved for use as monotherapy or in combination with methotrexate (MTX) in the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The aim of this paper was to review the studies on pharmacology, mode of action, pharmacokinetics, efficacy, and safety of baricitinib in patients with RA. Baricitinib provides an innovative approach to modulating the immune and inflammatory response in patients with RA, which is especially important in individuals who do not respond to disease-modifying antirheumatic drugs or standard biologic drugs (tumor necrosis factor inhibitors) or who lose response over time. Baricitinib therapy reduces symptoms of RA and improves the quality of life. Moreover, it has shown high efficacy and an acceptable safety profile in Phase III randomized controlled trials (RCTs) and become another JAK inhibitor approved for RA treatment, providing a useful alternative option. RCTs have revealed a significant benefit of baricitinib over placebo, MTX, and adalimumab in terms of standard efficacy outcomes, especially the American College of Rheumatology ACR20, ACR50, and ACR70 response rates. Additionally, a clinically meaningful improvement in patient-reported outcomes, including the quality of life, compared with placebo has been reported. The safety profile seems acceptable, although some rare but potentially severe adverse events have been observed, such as serious infections, opportunistic infections (eg, herpes zoster), malignancies, and cardiac or hepatic disorders. Baricitinib administered at an approved dose of 2 or 4 mg once daily offers a novel and promising alternative to parenterally administered biologic drugs used in RA treatment.
Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. [2021]To assess the safety and efficacy of baricitinib in patients with rheumatoid arthritis (RA) up to 128 weeks in a phase IIb study (NCT01185353).
Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis. [2023]Baricitinib, an orally available small-molecule inhibitor of Janus kinase (JAK)1 and JAK2, is indicated to treat active moderate-to-severe rheumatoid arthritis (RA).