CLINICAL TRIAL

LY3462817 for Arthritis

Waitlist Available · 18+ · All Sexes · Zlin, Czechia

This study is evaluating whether a drug may help reduce symptoms of rheumatoid arthritis.

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About the trial for Arthritis

Eligible Conditions
Rheumatoid Arthritis · Arthritis · Arthritis, Rheumatoid

Treatment Groups

This trial involves 3 different treatments. LY3462817 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
LY3462817
DRUG
Experimental Group 2
LY3462817
DRUG
Control Group 3
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

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Odds of Eligibility
High>50%
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 12.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether LY3462817 will improve 1 primary outcome and 5 secondary outcomes in patients with Arthritis. Measurement will happen over the course of Baseline, Week 12.

Change from Baseline for Mean Simplified Disease Activity Index (SDAI)
BASELINE, WEEK 12
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. Lower SDAI values indicate lower disease activity.
Change from Baseline on the 36 Item Short Form Health Survey (SF-36)
BASELINE, WEEK 12
The SF-36 is a health-related survey that assesses participant's health status and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, and vitality. The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.
Change from Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)
BASELINE, WEEK 12
DAS28 consists of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), hsCRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity (PaGADA_VAS) on a 0 to 100 millimeter (mm) VAS (0=very well to 100=very poor). A decrease in DAS28-CRP indicates an improvement in participant's condition.
Change from Baseline for Mean Clinical Disease Activity Index (CDAI)
BASELINE, WEEK 12
The CDAI measures disease activity in RA. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-100 mm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-100 mm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. Lower CDAI scores indicate lower disease activity. A negative change from baseline indicates improvement in condition.
Pharmacokinetics (PK): Observed Concentration of LY3462817
WEEK 12
PK: Observed Concentration of LY3462817
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20), (ACR50) and (ACR70)
WEEK 12
ACR responders are participants with at least 20%, 50% and 70% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants perceived degree of difficulty performing daily activities, acute phase reactant as measured by hsCRP, Patient's Assessment of Pain-Visual Analog Scale (Pain-VAS), Patient's Global Assessment of Disease Activity (PaGADA_VAS), and Physician's Global Assessment of Disease Activity (PhGADA_VAS).

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for arthritis?

Several drug treatment interventions are commonly used for arthritis. The efficacy of treatments for arthritis is often improved when they are combined with other treatments, such as exercise, and psychological therapy.

Anonymous Patient Answer

What is arthritis?

Osteoarthritis is the most common chronic degenerative joint disorder. In the United States, arthritis affects about 8 percent of all adults aged 20 years and older. The National Institutes of Health (NIH) estimated that in the US, arthritis costs $33.2 billion and results in 1.9 years of lost productivity for adults and 16.5 years of lost productivity for people over the age of 65.

Anonymous Patient Answer

Can arthritis be cured?

This article concludes the following about curing arthritis: 1. the disease cannot be cured; if one wants it cured, and treatment is given, they should always be in touch with a doctor who can treat problems that may go undiagnosed and untreated if they weren’t given treatment first; 2. pain may be an indicator of untreated disease but does not imply that a disease is necessarily present; 3. if patients do not have access to adequate health care it is important to bring them into the arena of the doctor first and not ask them if they have pain; 4. arthritis is most prevalent among older adults who are of high social class; 5. many of them are poor and cannot afford to go to the doctor; 6.

Anonymous Patient Answer

How many people get arthritis a year in the United States?

The ASIP annual update survey, the largest study of the burden of rheumatic diseases in the population, indicates a persistent shift in arthritis burden from a higher incidence of osteoarthritis cases to RA and PsA.

Anonymous Patient Answer

What causes arthritis?

The pathogenesis of arthritis can be broadly classified into inflammation-driven and non-inflammation-driven mechanisms. Inflammation-driven arthritis is triggered by local or systemic stimuli, such as infection by pathogens, trauma, tumour, and autoimmune disease. Once triggered, the response is often self-sustained, and therefore not reversed. The lack of efficient elimination of the inciting stimulus leads to an ongoing systemic inflammatory response, which ultimately leads to destruction of the joint. Non-inflammation-driven arthritis is caused by a defect in the joint itself, rather than a local or systemic defect.

Anonymous Patient Answer

What are the signs of arthritis?

A medical history alone is not enough in assessing the presentation of RA. Patient's history and physical exam together with special lab tests, including biopsy, are still the cornerstone of the diagnosis of RA and are essential to anticipate and prevent possible complications. Rheumatoid factor test is used to screen RA. Rheumatoid factor is a protein in blood, and if found it indicates that someone has a new onset of arthritis and, in most cases, it is indicative of rheumatoid arthritis. In the United States, rheumatoid factor is a specific test that is more commonly used than the arthritis clinic.

Anonymous Patient Answer

What is the primary cause of arthritis?

Approximately 40s, women have a better chance of getting primary Sjögren's syndrome. Arthritis may occur in up to 90% of primary Sjögren's syndrome, and is more common in other connective tissue diseases.

Anonymous Patient Answer

What are the latest developments in ly3462817 for therapeutic use?

These studies confirmed that ly3462817 can induce apoptosis in a spectrum of human cancer cells, and demonstrated synergistic effects on the action of ly1462817 vs the drug vorinostat. They also demonstrated that vorinostat enhances the efficacy of ly1462817 in the treatment of cancer cells. Further evaluation of vorinostat's combination with ly1462817 in cancer patients is warranted to evaluate its therapeutic efficacy and toxicity profile.

Anonymous Patient Answer

What are the common side effects of ly3462817?

The most common side effects in clinical trials of ly3462817 were nausea and vomiting. This may be dose dependent and may require the use of antiemetics prior to ly3462817 therapy. Although the FDA did not find any evidence of serious side effects, the product is not permitted for use without adequate patient monitoring and information from patients who have used it. The patient has to be informed and be aware of the possibilities of serious adverse effects from the product.

Anonymous Patient Answer

Has ly3462817 proven to be more effective than a placebo?

Ly-3462817 is effective in reducing inflammation as indicated by the significant decreases in circulating levels of CRP, aggrecan, anti-CCP and IL-6 observed in this study. Results from a recent paper are similar to that obtained in clinical trials with the FDA approved drug rivaroxaban. No significant differences were found between ly3061717 and a placebo. Clinical trials addressing these questions should continue.

Anonymous Patient Answer

What is the latest research for arthritis?

Arthritis has a huge burden on health care expenditure in the UK, especially where there are complications (i.e., heart disease or respiratory disease) caused by RA and other coexisting conditions leading the patient to need multiple treatments in a single hospital visit.

Anonymous Patient Answer

Does arthritis run in families?

Familial aggregation of arthritis is largely due to genetically determined predisposition. Familial aggregation should be considered a marker of genetic predisposition to arthritis, and in particular, should be used to identify patients at a high risk for developing the disease. Data from a recent study did not detect any specific associations between familial aggregation and certain rheumatic indications.

Anonymous Patient Answer
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