Clinical trials on Rheumatoid arthritis

Rheumatoid Arthritis: An Overview

Rheumatoid arthritis (RA) is a chronic, autoimmune disorder that primarily affects joints but can also have systemic implications, impacting various organs and tissues throughout the body. Characterized by inflammation and swelling in the joint lining, RA leads to pain, stiffness, and eventually, loss of joint function. Unlike osteoarthritis, which results from wear and tear of the joints, RA involves the body’s immune system mistakenly attacking the joint tissues, causing damage over time.

The exact cause of RA remains elusive, but it is believed to be a combination of genetic, environmental, and hormonal factors. Symptoms of RA can vary in severity and may come and go in episodes known as flares. Common signs include joint pain, swelling, stiffness (especially in the morning or after periods of inactivity), and fatigue. As the disease progresses, it can lead to joint deformity and erosion, significantly affecting a person’s quality of life.

Diagnosis of RA involves a combination of physical examinations, blood tests (to detect specific antibodies like rheumatoid factor and anti-CCP), and imaging tests such as X-rays and MRIs to assess joint damage. While there is no cure for RA, treatment options have significantly advanced, focusing on managing symptoms and improving joint function. These include medications (like NSAIDs, corticosteroids, DMARDs, and biologics), physical therapy, and in severe cases, surgery. Early diagnosis and aggressive treatment are crucial to slowing the progression of the disease and maintaining a high quality of life.

  • CT-EU-00116359

    Adalimumab-800CW distribution study and its fluorescence imaging in inflammatory bowel diseases and rheumatoid arthritis

    This clinical trial used a special fluorescent version of the drug adalimumab to precisely examine its distribution in inflamed areas in people with inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). These autoimmune diseases provoke the body’s immune system to attack the intestines or joints, leading to significant inflammation and discomfort.

    Typically, adalimumab works by inhibiting a protein called tumor necrosis factor alpha (TNFa), a major trigger of inflammation. However, the effectiveness of this medicine may vary and the reasons for this are not always clear. Therefore, in this study, adalimumab was combined with a special luminous dye, called adalimumab-800CW, that allows the drug to be precisely tracked in inflamed areas using advanced imaging techniques.

    The primary goal is to determine whether the glowing adalimumab reaches targeted inflamed areas in the gut or joints and to assess whether the level of accumulation correlates with therapeutic efficacy in each participant. The insights gained are intended to increase the ability to predict treatment response and adjust dosing for individual patients before initiating therapy.

    Participants in this study will be given a low dose of glowing adalimumab a few days before undergoing specialized imaging tests or endoscopy to monitor the drug’s location in the body. The safety and well-being of participants will be closely monitored throughout the study.

    • Adalimumab-800CW
  • TolDCB29 dendritic cell therapy in the treatment of rheumatoid arthritis

    This study aims to evaluate a new treatment for people suffering from rheumatoid arthritis. The treatment involves taking parts of a person’s own immune cells, called dendritic cells, and filling them with a special protein called B29 peptide. This produces TolDCB29, which is then injected back into the body near the lymph nodes in the groin area.

    The main goal of this study is to determine whether TolDCB29 treatment is safe for patients with rheumatoid arthritis. Scientists also want to see if it can help train the immune system to stop attacking the body’s own body, which causes joint inflammation and damage in rheumatoid arthritis.

    The patient will receive two injections of TolDCB29 approximately four weeks apart. Study doctors will start by giving a low dose to a small group, then increase the dose to the next group until they find the highest safe dose. Patients will be closely monitored for any side effects or worsening of symptoms of rheumatoid arthritis.

    This study only includes adults over 18 years of age with rheumatoid arthritis that has been well controlled with current medications for at least 12 weeks. During the study, patients can continue to take their existing arthritis medications, except Janus kinase inhibitors.

    • autologous mature tolerogenic monocyte-derived Dendritic Cells loaded with the B29 peptide of HSP70/TolDCB29
  • Study of the new oral drug LY3871801 for rheumatoid arthritis

    The aim of this study is to test a new drug called LY3871801 for people suffering from moderate to severe rheumatoid arthritis. The main goal is to see if this new drug can help reduce disease activity and improve symptoms better than a placebo. In the first part of the study, doctors will check how much the Disease Activity Score changes after 12 weeks of taking LY3871801 or a placebo. Then, in the second part, they will look at what percentage of patients experience significant improvement, defined as achieving an ACR50 response, which means reducing symptoms of rheumatoid arthritis by 50% or more. Both the real drug and the placebo will be taken by mouth.

    • placebo
    • LY3871801
  • Efficacy and safety study of rosnilimab in moderate to severe rheumatoid arthritis

    This study will evaluate the effectiveness and safety of Rosnilimab in patients with moderate to severe rheumatoid arthritis. Rosnilimab is an antibody that activates the PD-1 receptor, also known as ANB030. Patients will be randomly assigned to receive Rosnilimab or placebo.

    The main aim of the study is to assess changes in the 28-Joint Disease Activity Index based on the concentration of C-reactive protein (DAS28-CRP) after 12 weeks of treatment. DAS28-CRP is a validated tool that assesses disease activity based on the number of painful and swollen joints and the concentration of C-reactive protein in the blood. A reduction in DAS28-CRP indicates an improvement in the patient’s condition.

    This study aims to test whether Rosnilimab is effective and safe in the treatment of rheumatoid arthritis. If the results are promising, this drug could become a new treatment option for patients suffering from this disease.

    • placebo
    • Rosnilimab
  • A study comparing upadacitinib versus adalimumab in the treatment of rheumatoid arthritis

    This clinical trial is studying a new medication called upadacitinib for treating moderate to severe rheumatoid arthritis. Rheumatoid arthritis is a chronic condition that causes pain, stiffness, swelling, and loss of joint function. The study will compare upadacitinib, which is taken as an oral tablet once daily, to adalimumab (brand name Humira), which is an injection given under the skin every other week.

    The main goal is to see how effective upadacitinib is at reducing disease activity compared to adalimumab. The study will measure the percentage of participants who achieve a certain level of low disease activity based on a score called the DAS28-CRP, which looks at tender and swollen joints, overall disease activity, and inflammation levels.

    This is a double-blind study, meaning neither the participants nor the study doctors will know which treatment each participant is receiving. Participants will attend regular visits at a hospital or clinic for medical assessments, checking for side effects, and completing questionnaires. There may be a higher treatment burden compared to standard care. The study is designed to assess the safety and effectiveness of upadacitinib compared to adalimumab in treating moderate to severe rheumatoid arthritis.

    • Adalimumab
    • Upadacitinib
  • Exploring a new treatment combination for rheumatoid arthritis: baricitinib plus anti-TNF

    This clinical trial is focused on finding a more effective treatment for people with Rheumatoid Arthritis (RA) who haven’t responded well to previous therapies. The study is comparing two different approaches: one group will receive a combination of baricitinib treatment and an anti-TNF therapy (adalimumab), while the other group will receive baricitinib along with a placebo. The main goal is to see which group shows a greater improvement in their RA symptoms, specifically looking for a 50% improvement in symptoms, known as an ACR 50 response, after 24 weeks from the start of the treatment.

    Baricitinib is a medication that targets certain pathways in the body’s immune system to reduce inflammation and pain in RA. Anti-TNF therapy, like adalimumab, works by blocking the action of a protein in the body that causes inflammation. By combining these two treatments, researchers hope to see a more significant improvement in RA symptoms than with baricitinib alone.

    The trial is important because it aims to provide a new option for patients with RA who have not found relief with current treatments. It’s designed to test the safety and effectiveness of using these two different types of medications together.

    • placebo
    • Adalimumab
    • Baricitinib
  • To evaluate the efficacy and safety of burfiralimab in combination with standard treatment for rheumatoid arthritis

    The study is investigating a new treatment option for people with moderate to severe rheumatoid arthritis (RA). This study focuses on assessing the effectiveness and safety of a drug called burfiralimab, administered as intravenous infusions. The drug is being tested alongside standard treatments for RA, known as disease-modifying antirheumatic drugs, to see if it can provide better relief from RA symptoms.

    This is a multicenter, randomized, double-blind, placebo-controlled study. This means that participants will be randomly assigned to receive the drug burfiralimab or a placebo, and neither participants nor researchers will know who is receiving which treatment. This helps ensure the results are impartial.

    Study participants will receive biweekly intravenous infusions of burfiralimab or placebo for a total of 10 weeks. The main goal is to see whether people receiving burfiralimab experience significant improvement in RA symptoms compared to those receiving placebo. Improvement is measured by ACR 20 criteria, which include a reduction in joint swelling and tenderness.

    The study is open to people aged 18 to 80 who have moderate to severe RA and have not responded well to standard therapy. The safety and effects of treatment will be closely monitored throughout the study period, with particular emphasis on improving disease activity and quality of life for up to 18 weeks after treatment initiation.

    • Burfiralimab
    • placebo
  • Study of the safety of Imvotamab in the treatment of rheumatoid arthritis

    This test is for people with moderate or severe rheumatoid arthritis who has not improved with previous treatment. The main goal is to test the safety and tolerance of the body to a new drug called Imvotamab.

    In this study, participants will receive Imvotamab or a placebo directly into their veins. A placebo looks like a drug but contains no active drug. This method helps to understand the effects of Imvotamab by comparing it with a placebo. The study was carefully designed to monitor the effects of the drug, including any side effects and side effects that participants may experience. Of particular interest is the body’s response to the drug and the behavior of the drug in the body over time.

    This study is being conducted at multiple sites and involves approximately 24 participants. Each participant will participate in the study for a maximum of 52 weeks. During this time, their health and any changes in symptoms of rheumatoid arthritis will be closely monitored.

    Participating in this study could potentially provide new insight into an individual’s condition and contribute to the development of new treatments for rheumatoid arthritis. Participation in the study is voluntary, and all necessary information will be provided to enable you to make an informed decision about joining the study.

    • Imvotamab
    • placebo
  • Study of the effects of filgotinib on B cells in patients with rheumatoid arthritis

    This clinical trial focuses on the treatment of Rheumatoid Arthritis (RA), specifically in patients who have not fully responded to standard treatments like methotrexate. The study is exploring the effectiveness of a medication called Filgotinib, which works by targeting and inhibiting certain enzymes in the body known as Janus kinases. These enzymes are involved in the inflammation and immune response that contribute to RA. By inhibiting these enzymes, Filgotinib may help reduce the activity of harmful B cells that produce anti-citrullinated protein antibodies (ACPA), which are believed to play a key role in driving the disease.

    The trial will compare the effects of Filgotinib to another medication called Adalimumab, which works by targeting a different part of the immune response. The main goal is to see if there is a change in the frequency of ACPA-expressing B cells after 24 weeks of treatment. This could indicate whether Filgotinib is effective in altering the course of the disease by targeting these specific cells.

    Patients participating in this study have RA and are ACPA-positive, meaning their condition is associated with a specific type of antibody that is linked to more severe disease activity. The study is particularly interested in those who have not fully benefited from methotrexate, a commonly used medication for RA. By joining this trial, patients have the opportunity to receive a potentially new treatment that could offer better control of their RA symptoms and disease progression.

    • Adalimumab
    • Filgotinib
  • To evaluate the safety and effects of GS-0272 in patients with rheumatoid arthritis or lupus

    A clinical trial is being introduced focusing on a new drug called GS-0272, intended for people with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). The goal of this study is to gather more information about GS-0272, especially regarding its safety and good tolerability when administered in multiple doses.

    The Phase 1b study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of GS-0272 in adult participants with rheumatoid arthritis or systemic lupus erythematosus. The study will be conducted at multiple sites, and participants will be randomly assigned to receive the study drug GS-0272 or a placebo administered subcutaneously.

    The main goals of this study are to understand how safe GS-0272 is and how participants’ bodies respond to it after receiving multiple doses. Adverse events or serious adverse events will be closely monitored, as will any changes in laboratory test results that may indicate that the medicine is not well tolerated. Additionally, the study will examine how GS-0272 travels and is processed by the body, which is known as pharmacokinetics.

    This study is an important step in determining whether GS-0272 may be a beneficial treatment option for people with RA or SLE. The safety and well-being of participants are the highest priority and a commitment has been made to provide all necessary information and support throughout the study.

    • GS-0272- new potential medication for Rheumatoid Arthritis and Systemic Lupus Erythematosus
    • placebo
  • Study of Tc 99m tilmanocept, a radiotracer used in patients with rheumatoid arthritis

    This clinical trial is focused on understanding how a special imaging technique using a substance called Tc 99m tilmanocept compares with a detailed tissue analysis in detecting inflammation in the joints of people with Rheumatoid Arthritis (RA). Rheumatoid Arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and swelling. In this study, researchers are using Tc 99m tilmanocept, which is a type of radiotracer that specifically targets and binds to certain cells in the immune system that are active in areas of inflammation. By doing so, it helps create clear images of inflamed areas in the joints.

    The main goal of the study is to see how well the uptake of Tc 99m tilmanocept in the joints, shown through imaging, matches with the levels of a specific marker called CD206 found in the joint tissues. CD206 is a marker present on certain immune cells involved in RA, and its presence can be determined through a method called Immunohistochemical (IHC) analysis. This analysis involves looking at the joint tissues under a microscope after they have been treated with special dyes that highlight the CD206 marker.

    This study is important because it might provide a new way to measure the severity of RA in patients without the need for invasive tissue sampling. The study involves a single dose of the radiotracer and will track participants for up to 45 days to assess the relationship between the imaging results and the tissue analysis findings. This could help doctors better understand and treat Rheumatoid Arthritis in the future.

    • Tc 99m tilmanocept
  • Evaluating SAR441566 in Adults with Moderate-to-Severe Rheumatoid Arthritis

    This clinical trial is designed to explore the effectiveness and safety of a new medication called SAR441566 in adults who are dealing with moderate-to-severe rheumatoid arthritis (RA). If you’re an adult who hasn’t found relief from RA with methotrexate alone and haven’t tried biologic or targeted synthetic disease-modifying anti-rheumatic drugs yet, this study might be of interest to you.

    The study is set up as a double-blind, placebo-controlled experiment, which means neither you nor the study team will know if you’re receiving the actual medication or a placebo. This is a key part of ensuring the results are unbiased. You’ll be randomly placed into one of five groups, with some receiving SAR441566 and others a placebo, all alongside your regular methotrexate treatment.

    The trial will last for about 149 days, including a 6-week period before the treatment starts to confirm your eligibility, a 12-week treatment phase, and a 2-week follow-up period after treatment ends to monitor your safety. Throughout the study, you’ll visit the study center 8 times.

    One of the main goals of this study is to see if participants show a significant improvement in their RA symptoms, specifically looking for a 20% improvement in the American College of Rheumatology (ACR) score by week 12. This score measures various aspects of RA, including joint tenderness and swelling, pain levels, and overall physical function.

    By participating, you’ll be contributing to research that could lead to new treatment options for RA, potentially offering relief to many who are searching for more effective therapies.

    • SAR441566
    • placebo
  • Safety study of IMB-101 in patients with rheumatoid arthritis and healthy volunteers

    A clinical trial is underway focusing on a new treatment called IMB-101 for people with rheumatoid arthritis (RA). The purpose of this study is to investigate the safety and body tolerability of IMB-101 administered intravenously. The study will also analyze the effect of this treatment on the body and how the body processes it.

    The study will include both healthy volunteers and participants with active RA who are currently taking a stable dose of methotrexate. This is intended to compare the effects of IMB-101 in different bodies, providing a comprehensive understanding of its impact.

    A key part of this study is monitoring for any side effects or adverse reactions, known as treatment-emergent adverse events and serious adverse events. These are essentially any health changes or health problems that arise after you start treatment, ranging from minor to major. Participants’ safety is a top priority, and any health changes will be closely monitored and recorded for up to 85 days after the first dose of the study drug.

    This study is a randomized, double-blind, placebo-controlled trial. This means that participants will be randomly assigned to receive IMB-101 or a placebo, and neither the participants nor the research team will know who will receive the treatment or the placebo. This method helps ensure the impartiality and reliability of the research results.

    • IMB-101
    • placebo
  • Study of the effectiveness of CPL409116 in the treatment of rheumatoid arthritis

    A clinical trial is being presented that focuses on evaluating the efficacy and safety of a new drug called CPL409116 in individuals with active rheumatoid arthritis (RA) who have not achieved improvement with methotrexate alone. The study is designed to last for 12 weeks and aims to enroll approximately 100 participants, who will be divided into four groups. Each group will receive different doses of CPL409116 or a placebo, in addition to their continued methotrexate treatment.

    CPL409116 is a promising drug that works by targeting specific pathways in the body known to contribute to inflammation and RA symptoms. By inhibiting these pathways, CPL409116 could potentially reduce disease activity and improve symptoms. The main objective of this study is to determine how well CPL409116 can decrease disease activity compared to a placebo, which will be measured using the DAS28(CRP) score. This score takes into account the number of swollen or tender joints, the level of a specific protein in the blood that indicates inflammation, and how the patient assesses their disease activity.

    Participants in this study will be randomly assigned to one of the treatment groups and will take the study drug or placebo twice daily for 85 consecutive days. It is important for participants to have been on a stable dose of methotrexate for at least 12 weeks prior to joining the study, with no dosage changes for at least 8 weeks before the study begins.

    This study aims not only to evaluate the efficacy of CPL409116 but also its safety, ensuring that it is well-tolerated by participants. If someone is struggling with active rheumatoid arthritis and has not achieved an adequate response to methotrexate, this study may provide an opportunity to access a potentially new treatment option while contributing to significant research that could benefit other individuals with RA in the future.

    • CPL409116
    • placebo
  • Study of the safety and effects of SOL-116 in healthy subjects and patients with rheumatoid arthritis

    This is a study of a monoclonal antibody (SOL-116) targeting BSSL (biliary salt-stimulated lipase). The study aims to investigate a new treatment option that could potentially provide relief to people suffering from rheumatoid arthritis. This is a phase I placebo-controlled trial, which means that participants will be randomly assigned to receive the study drug or a placebo. Neither participants nor the research team will know who is receiving the actual drug, ensuring the results are unbiased.

    The study is divided into three parts. In the first part, different doses of the drug will be tested on healthy volunteers to find the safest dose. In the second part, this dose will be tested in patients with rheumatoid arthritis. Finally, the third part will involve administering the drug repeatedly to healthy volunteers to understand how the body responds to it over time.

    Throughout the study, the safety, and tolerability of SOL-116 will be closely monitored by monitoring for any adverse events, changes in clinical laboratory assessments, immune responses, and changes in vital signs such as blood pressure, heart rate, and body temperature. You will also be checked for reactions at the injection site, and an electrocardiogram (ECG) will be taken to monitor your heart health.

    The study will last approximately 90 days from screening to completion, during which time it will collect valuable information on how SOL-116 is processed in the body (pharmacokinetics) and its safety and tolerability.

    • SOL-116
    • placebo
  • Exploring new treatment options for rheumatoid arthritis with the new drug Resomelagon

    The RESOLVE trial will investigate the effectiveness and safety of the new treatment option AP1189 (Resomelagon) in adults with rheumatoid arthritis (RA) who have not achieved relief with methotrexate (MTX) alone. This study is divided into two main parts, each focusing on different aspects of treatment to ensure a thorough assessment.

    In the first part of the study, participants will be randomly assigned to receive one of three different doses of AP1189 (Resomelagon) or placebo, in addition to their ongoing MTX treatment. This phase will last 4 weeks and is intended to determine the most effective dose of AP1189 by observing changes in the severity of RA symptoms, specifically looking for a 20% improvement in symptoms as measured by the American College of Rheumatology (ACR20) criteria. The results of this stage will help in selecting the dose for the next part of the study.

    The second part extends the treatment period to 12 weeks, during which participants will continue selected doses of AP1189 or placebo, along with stable MTX treatment. The primary objectives are to further evaluate the effectiveness of AP1189 by observing changes in ACR20 compared to baseline and to monitor the safety and tolerability of treatment by recording any adverse events that occur.

    This study provides an opportunity for RA patients who have not responded well to MTX alone to potentially improve symptoms and contribute to the development of a new treatment option. The safety and well-being of participants is of the utmost importance and should be monitored and assessed regularly to ensure any risks are minimized.

    • placebo
    • Resomelagon/AP1189