Targeted Therapies for Rheumatoid Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test new targeted treatments for rheumatoid arthritis (RA), a condition that causes joint pain and swelling. The study consists of three parts, each testing different approaches: one with lutikizumab alone (a type of targeted therapy), another with ravagalimab alone (another targeted therapy), and a third combining both. The goal is to determine the effectiveness and safety of these treatments for individuals whose RA is not well-managed by their current medications. Participants who have tried one or two RA treatments without success might be suitable for this trial. Regular clinic visits will monitor the treatment's effects. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of methotrexate (a medication for rheumatoid arthritis). If you're taking NSAIDs, acetaminophen, certain opioids, or corticosteroids, you must be on a stable dose for at least one week before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that lutikizumab was generally well-tolerated. Participants experienced less pain than those taking a placebo, suggesting its potential safety. Some side effects occurred, but they were uncommon and mostly mild.
Ravagalimab has also undergone safety studies in other inflammatory diseases. Research has shown it to be generally safe, with most side effects being mild or moderate. The most common issue was reactions at the injection site, typical for this kind of treatment.
The combination of lutikizumab and ravagalimab is newer, and specific safety data remains limited. This trial, in its early stages, aims to gather more safety information. Treatments at this phase usually have some safety data but require further testing to confirm their safety.
Participants should know that while these treatments have shown promise, ongoing research seeks to better understand their safety. Regular check-ups and monitoring during the trial will help manage any potential side effects.12345Why are researchers excited about this trial's treatments?
Lutikizumab and Ravagalimab are exciting new treatments for rheumatoid arthritis because they offer a novel approach to managing this condition. Unlike most traditional therapies, which often involve nonsteroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs), Lutikizumab and Ravagalimab target specific inflammatory pathways. Lutikizumab works by inhibiting interleukin-1, a key player in the inflammatory process, while Ravagalimab blocks the interaction between the immune cells and the receptors that lead to inflammation. This targeted approach could mean fewer side effects and potentially better efficacy in reducing joint inflammation and pain. Researchers are hopeful that these treatments could offer more personalized and effective options for patients with rheumatoid arthritis.
What evidence suggests that this trial's treatments could be effective for Rheumatoid Arthritis?
This trial will evaluate different treatment options for rheumatoid arthritis. Participants in one arm will receive Lutikizumab, which studies have shown can significantly reduce pain compared to a placebo in certain conditions. Specifically, a 100 mg dose lowered pain levels according to the WOMAC score, a tool used to measure pain. However, it did not improve pain or imaging results for some types of arthritis. Another arm will study Ravagalimab, which researchers are investigating for its effects on joint inflammation. While detailed human data for its use in rheumatoid arthritis is not yet available, it is being tested to see if it can reduce the number of tender and swollen joints. Additionally, the trial includes an arm that combines Lutikizumab and Ravagalimab, although specific results on its effectiveness are not yet available. Together, these treatments aim to better target inflammation and help manage symptoms of rheumatoid arthritis.12346
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for people with moderately to severely active Rheumatoid Arthritis who have tried at least one but no more than two biologic/targeted synthetic DMARD therapies without success or had to stop due to side effects. They must be on a stable dose of methotrexate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive targeted therapies, including lutikizumab and ravagalimab, in various substudies
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lutikizumab
- Placebo
- Ravagalimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois