What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis, particularly biologic agents such as TNF inhibitors (adalimumab, infliximab, etanercept), abatacept, and rituximab, are associated with several side effects. These can include an increased risk of infections, injection site reactions, and infusion-related reactions. More serious but less common side effects include the potential for developing certain cancers, cardiovascular issues, and autoimmune conditions. Patients may also experience headaches, gastrointestinal symptoms, and hypersensitivity reactions. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several biologic agents and immunomodulatory drugs for the treatment of Rheumatoid Arthritis (RA). These include TNF inhibitors such as infliximab, adalimumab, and etanercept, which work by blocking tumor necrosis factor to reduce inflammation. Other biologics like abatacept, which inhibits T-cell activation, and rituximab, which targets B-cells, are also used. Additionally, JAK inhibitors like tofacitinib and baricitinib, which interfere with the Janus kinase pathway, have been approved for RA treatment.

What other types of research exist?

Promising, novel alternatives to Imvotamab for Rheumatoid Arthritis patients in 2024 include Janus kinase (JAK) inhibitors such as tofacitinib, baricitinib, upadacitinib, and filgotinib. These have shown efficacy and safety in patients with inadequate responses to methotrexate.

← Back to Search

Monoclonal Antibodies

Imvotamab for Rheumatoid Arthritis

Phase 1

Recruiting

Research Sponsored by IGM Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

- Intolerance to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD.

Minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count at the screening and baseline visit (SJC/TJC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 52

Awards & highlights

Study Summary

This trial will test if a drug (imvotamab) is safe and tolerable in people with RA who have failed other treatments. Placebos will also be given.

Who is the study for?

Adults over 18 with moderate to severe rheumatoid arthritis who haven't responded well to at least two different biologic or targeted synthetic DMARDs. Participants should have active disease, shown by a certain number of swollen and tender joints and high inflammation markers in blood tests. They shouldn't have other autoimmune diseases (except secondary Sjögren's syndrome) or be on high doses of steroids.Check my eligibility

What is being tested?

The trial is testing the safety and effects of Imvotamab, an experimental medication for rheumatoid arthritis, compared to a placebo. The drug or placebo is given intravenously. The goal is to see if Imvotamab can help people who didn't get better with previous treatments.See study design

What are the potential side effects?

While specific side effects for Imvotamab are not listed, common side effects for drugs treating rheumatoid arthritis may include injection site reactions, increased risk of infections, headaches, nausea, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I cannot tolerate at least 2 different types of advanced arthritis medications.

Select...

I have at least 6 swollen and 6 tender joints.

Select...

I tested positive for ACPA and/or RF.

Select...

I have been on a stable dose of corticosteroids, not more than 10 mg/day of prednisone, for at least 2 weeks.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Imvotamab (Dose Escalation)Experimental Treatment1 Intervention

Imvotatmab administered intravenously

Group II: PBO IV QW x 4 dosesPlacebo Group1 Intervention

Placebo administered intravenously

0 / 5Eligibility criteria met

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) include biologics and immunomodulatory drugs. Biologics, such as TNF inhibitors (e.g., infliximab) and IL-6 inhibitors, work by targeting specific components of the immune system that drive inflammation and joint damage. Immunomodulatory drugs like methotrexate suppress the overall immune response to reduce inflammation. These treatments are crucial for RA patients as they help manage symptoms, prevent joint damage, and improve quality of life. The study of Imvotamab, likely a biologic, aims to offer another targeted approach for patients who have not responded to existing therapies.

[Mechanism of action of gold compounds].

Find a Location

Who is running the clinical trial?

IGM Biosciences, Inc.Lead Sponsor

7 Previous Clinical Trials

345 Total Patients Enrolled

Rebecca KunderStudy DirectorIGM Biosciences

1 Previous Clinical Trials

18 Total Patients Enrolled

~12 spots leftby Feb 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.