What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis, particularly immune-modulating therapies like TNF-alpha inhibitors and IL-6 inhibitors, often have side effects such as increased risk of infections, injection site reactions, and gastrointestinal issues. TNF-alpha inhibitors can also lead to a higher risk of cardiovascular events, although some studies suggest they may reduce this risk. Other biologics may cause hypersensitivity reactions, liver toxicity, and bone marrow suppression. It is essential to monitor patients closely for these adverse effects to manage them effectively.

What prior FDA approvals exist?

Several drugs have been FDA-approved for the treatment of Rheumatoid Arthritis, focusing on immune modulation to reduce inflammation. TNF inhibitors such as etanercept, infliximab, and adalimumab are commonly used and have shown significant efficacy in reducing RA symptoms. IL-6 inhibitors like tocilizumab and sarilumab also play a crucial role in managing RA by targeting inflammatory pathways. Additionally, other biologic agents like abatacept, which modulates T-cell activation, and rituximab, which depletes B cells, have been approved for RA treatment. These treatments aim to control the immune response and reduce inflammation, similar to the investigational drug Peresolimab.

What other types of research exist?

Promising novel alternatives to Peresolimab for rheumatoid arthritis patients include: 1) Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, which has shown efficacy in immune-mediated disorders. 2) Risankizumab, another monoclonal antibody targeting interleukin-23, which has demonstrated positive results in inflammatory conditions. 3) JAK inhibitors like Tofacitinib and Upadacitinib, which modulate the JAK-STAT signaling pathway involved in inflammation. These alternatives offer different mechanisms of action and have shown promising results in clinical trials for RA.

← Back to Search

Monoclonal Antibodies

Peresolimab for Rheumatoid Arthritis (RESOLUTION-1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Summary

This trial is testing a new medication called peresolimab to see if it is safe and effective for adults with moderate to severe rheumatoid arthritis. The medication aims to reduce inflammation and joint damage by calming the immune system.

Who is the study for?

This trial is for adults with rheumatoid arthritis that's moderately-to-severely active. Participants must have had the condition for at least 3 months and not responded well to previous treatments. They should not have severe RA, poorly controlled diabetes or hypertension, serious heart issues, chronic kidney disease stage IIIb or worse, or other major inflammatory diseases.

What is being tested?

The study tests Peresolimab's safety and effectiveness against a placebo in treating rheumatoid arthritis. It aims to see if Peresolimab can help those who haven't done well on standard treatments.

What are the potential side effects?

While specific side effects of Peresolimab are not listed here, common side effects from drugs like it may include injection site reactions, increased risk of infections, headaches, nausea and potential liver enzyme abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving American College of Rheumatology (ACR)20

Secondary study objectives

Percentage of Participants Achieving ACR50 or ACR70

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Peresolimab Dose 3Experimental Treatment1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group II: Peresolimab Dose 2Experimental Treatment1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group III: Peresolimab Dose 1Experimental Treatment1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group IV: PlaceboActive Control1 Intervention

Participants will be give placebo by subcutaneous injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peresolimab

2023

Completed Phase 1

~60

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rheumatoid Arthritis (RA) focus on modulating the immune system to reduce inflammation, which is crucial for preventing joint damage and improving quality of life. Methotrexate, a cornerstone in RA treatment, inhibits dihydrofolate reductase, reducing the proliferation of immune cells. TNF inhibitors, such as infliximab and etanercept, block tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. JAK inhibitors, like tofacitinib, interfere with the Janus kinase pathways, which are critical for the signaling of various inflammatory cytokines. These treatments help to decrease the inflammatory response, thereby reducing pain, swelling, and long-term joint damage in RA patients. Peresolimab, being studied for its immune-modulating properties, aims to offer similar benefits by targeting specific immune pathways to control inflammation.

Ten years of infliximab: insights from clinical trials in rheumatoid arthritis.