LY3871801 for Rheumatoid Arthritis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Eli Lilly and Company
Prior Safety Data
Trial Summary
What is the purpose of this trial?The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).
What safety data is available for LY3871801 in treating rheumatoid arthritis?The provided research does not contain any safety data specifically for LY3871801, ocadusertib, or any of its other names like Placebo, Control, or Dummy Treatment. The studies focus on the safety and efficacy of other treatments such as tofacitinib and upadacitinib for rheumatoid arthritis.3471011
What data supports the idea that LY3871801 for Rheumatoid Arthritis is an effective treatment?The available research does not provide any specific data on LY3871801 for Rheumatoid Arthritis. Instead, it focuses on other drugs like tofacitinib and peficitinib, which are used to treat the same condition. These studies show that tofacitinib and peficitinib can be effective in reducing symptoms and joint damage in patients with rheumatoid arthritis. However, there is no information here about LY3871801's effectiveness for this condition.14568
Is the drug LY3871801 a promising treatment for Rheumatoid Arthritis?The information provided does not directly mention LY3871801 or its effectiveness for Rheumatoid Arthritis. The articles focus on other drugs like tofacitinib, rituximab, and tocilizumab, but do not provide evidence about LY3871801. Therefore, we cannot determine if LY3871801 is promising based on this information.246912
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves evaluating a new treatment, it's possible that some medication adjustments might be required. Please consult with the trial coordinators for specific guidance.
Eligibility Criteria
This trial is for adults with active moderate-to-severe rheumatoid arthritis (RA) who have had RA for at least 3 months and haven't responded well to previous treatments. Participants should have a significant number of swollen and tender joints. Those with severe other diseases or heart, kidney, lung problems, or different inflammatory conditions are excluded.Treatment Details
The study tests the effectiveness and safety of LY3871801 compared to a placebo in treating RA. It's an adaptive Phase 2a/2b trial, meaning it can change based on results as the trial progresses to find the best dose and treatment response.
6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3871801 Phase 2aExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group II: LY3871801 Dose 3 Phase 2bExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group III: LY3871801 Dose 2 Phase 2bExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group IV: LY3871801 Dose 1 Phase 2bExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group V: Placebo Phase 2aPlacebo Group1 Intervention
Participants will receive placebo.
Group VI: Placebo Phase 2bPlacebo Group1 Intervention
Participants will receive placebo.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Hinsdale Orthopaedics - Illinois Bone & Joint InstituteHinsdale, IL
Accurate Clinical Research, IncLake Charles, LA
Overlake Arthritis and Osteoporosis CenterBellevue, WA
Newport Huntington Medical GroupHuntington Beach, CA
More Trial Locations
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
Rigel PharmaceuticalsIndustry Sponsor
References
Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. [2022]To compare the efficacy, safety, and tolerability of 5 doses of oral tofacitinib (CP-690,550) or adalimumab monotherapy with placebo for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response to disease-modifying antirheumatic drugs.
A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. [2022]To compare the efficacy, safety, and tolerability of 6 dosages of oral tofacitinib (CP-690,550) with placebo for the treatment of active rheumatoid arthritis (RA) in patients receiving a stable background regimen of methotrexate (MTX) who have an inadequate response to MTX monotherapy.
Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-label, longterm extension studies. [2022]To describe the longterm safety and efficacy profile of tofacitinib in patients with moderate to severe active rheumatoid arthritis (RA).
Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study. [2022]To evaluate oral tofacitinib versus placebo for treatment of active rheumatoid arthritis in Japanese patients with inadequate response to disease-modifying antirheumatic drugs.
Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis. [2018]To evaluate the efficacy and safety of orally administered once-daily peficitinib in combination with limited conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with moderate-to-severe rheumatoid arthritis (RA).
Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. [2020]Optimal targeted treatment in rheumatoid arthritis requires early identification of failure to respond. This post hoc analysis explored the relationship between early disease activity changes and the achievement of low disease activity (LDA) and remission targets with tofacitinib.
Efficacy and safety of tofacitinib modified-release 11 mg once daily plus methotrexate in adult patients with rheumatoid arthritis: 24-week open-label phase results from a phase 3b/4 methotrexate withdrawal non-inferiority study (ORAL Shift). [2021]To report the efficacy, safety and patient-reported outcome measures (PROs) of tofacitinib modified-release 11 mg once daily plus methotrexate in patients with rheumatoid arthritis (RA) from the open-label phase of Oral Rheumatoid Arthritis Trial (ORAL) Shift.
Post hoc analysis of clinical characteristics of patients with radiographic progression in a Japanese phase 3 trial of peficitinib and methotrexate treatment (RAJ4). [2023]To determine the efficacy of peficitinib in reducing joint damage and predictive factors affecting treatment response in Japanese patients with rheumatoid arthritis.
Rituximab versus tocilizumab in rheumatoid arthritis: synovial biopsy-based biomarker analysis of the phase 4 R4RA randomized trial. [2023]Patients with rheumatoid arthritis (RA) receive highly targeted biologic therapies without previous knowledge of target expression levels in the diseased tissue. Approximately 40% of patients do not respond to individual biologic therapies and 5-20% are refractory to all. In a biopsy-based, precision-medicine, randomized clinical trial in RA (R4RA; n = 164), patients with low/absent synovial B cell molecular signature had a lower response to rituximab (anti-CD20 monoclonal antibody) compared with that to tocilizumab (anti-IL6R monoclonal antibody) although the exact mechanisms of response/nonresponse remain to be established. Here, in-depth histological/molecular analyses of R4RA synovial biopsies identify humoral immune response gene signatures associated with response to rituximab and tocilizumab, and a stromal/fibroblast signature in patients refractory to all medications. Post-treatment changes in synovial gene expression and cell infiltration highlighted divergent effects of rituximab and tocilizumab relating to differing response/nonresponse mechanisms. Using ten-by-tenfold nested cross-validation, we developed machine learning algorithms predictive of response to rituximab (area under the curve (AUC) = 0.74), tocilizumab (AUC = 0.68) and, notably, multidrug resistance (AUC = 0.69). This study supports the notion that disease endotypes, driven by diverse molecular pathology pathways in the diseased tissue, determine diverse clinical and treatment-response phenotypes. It also highlights the importance of integration of molecular pathology signatures into clinical algorithms to optimize the future use of existing medications and inform the development of new drugs for refractory patients.
A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs. [2023]Upadacitinib, an oral Janus kinase (JAK) inhibitor, is used to manage rheumatoid arthritis. The objective was to generate statistical evidence from the existing data for upadacitinib efficacy and safety in various treatment regimens with different dosages in active rheumatoid arthritis patients. We searched PubMed, Cochrane, and ClinicalTrials.gov using PRISMA guidelines, providing data on the efficacy and safety of upadacitinib versus placebo in rheumatoid arthritis. 20% improvement in the American College of Rheumatology (ACR20) score response at 12 weeks was the primary outcome measure. Safety in adverse events, infections, or hepatic dysfunction was considered. The Mantel-Haenszel formula with random effect was used for the pooled odds ratio (OR) at a 95% confidence interval (CI) for dichotomous data. Meta-analysis was performed using RevMan version 5.4. Statistical heterogeneity was reported using I2 statistics; I2 > 75% was considered significant heterogeneity. A P value of less than 0.05 was considered significant. Data from 3233 patients were included in the analysis. The use of upadacitinib was associated with increased rates of achieving an ACR20 response compared with placebo (pooled OR 3.71; 95% CI 3.26-4.23; p-value <0.00001). Compared to a placebo, a 12 mg twice daily dose had the greatest effect, followed by a 15 mg once daily dose. Compared to the placebo, the incidence of any adverse event (pooled OR 1.66; 95% CI 1.36-2.02; p-value 0.0001) and infection (pooled OR 1.46; 95% CI 1.23-1.74; p-value 0.001) was found to be significantly higher in upadacitinib. Other adverse events, such as hepatic disorders and herpes zoster infections, were not statistically significant (p-value> 0.05). Maximum adverse events were seen at 12 mg twice daily. Upadacitinib, 15 mg once daily in combination with Methotrexate, was the most efficacious treatment regimen and was not associated with a significant risk for treatment-related adverse events in rheumatoid arthritis patients.
Clinical scenarios-based guide for tofacitinib in rheumatoid arthritis. [2023]Tofacitinib was the first Janus kinase inhibitor to be approved for the treatment of rheumatoid arthritis (RA), and there is a large body of data to inform the efficacy and safety of this drug for patients at different places in their treatment journeys and with diverse demographics and characteristics. Here, we summarize tofacitinib clinical efficacy and safety data from some clinical trials, post hoc analyses, and real-world studies, which provide evidence of the efficacy of tofacitinib in treating patients with RA at various stages of their treatment journeys, and with differentiating baseline characteristics, such as age, gender, race, and body mass index. In addition, we review the safety data available from different patient subpopulations in the tofacitinib clinical development program, real-world data, and findings from the ORAL Surveillance post-marketing safety study that included patients aged ⩾50 years with pre-existing cardiovascular risk factors. The available efficacy and safety data in these subpopulations can enable better discussions between clinicians and patients to guide informed decision-making and individualized patient care.
Biological/targeted synthetic DMARDs do not arrest bone loss in patients with rheumatoid arthritis: a multicenter prospective observational study. [2023]To elucidate the differential effects of biological/target synthesized DMARDs (b/tsDMARDs) on bone metabolism in patients with rheumatoid arthritis (RA) in a real-world cohort.