Evaluating SAR441566 in Adults with Moderate-to-Severe Rheumatoid Arthritis

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    What is this study about?

    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.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Brno-Sever , Czechia

      Uherske Hradiste , Czechia

      Hamburg , Germany

      Ratingen , Germany

      Lublin , Poland

      Lublin , Poland

      Bialystok , Poland

      Bytom , Poland

      Poznan , Poland

      Grodzisk Mazowiecki , Poland

      Barcelona / Sabadell , Spain

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, here are the steps you, as a participant, would need to follow:

      1. **Run-in Period (6 weeks ± 3 days before randomization):** This period is used to determine your eligibility for the trial. During this time, your health and condition will be closely monitored to ensure that you meet the trial’s criteria.

      2. **Randomization:** If you are found eligible during the run-in period, you will be randomly assigned to one of the study groups. These groups include different dose regimens of the investigational drug SAR441566 or a placebo group. This process ensures the study’s fairness and scientific validity.

      3. **Treatment Period (12 weeks ± 3 days):** Depending on the group you are assigned to, you will receive:
      – **SAR441566 dose regimen A, B, C, or D:** If you are in one of these groups, you will receive the specified dose of SAR441566 for 12 weeks.
      – **Placebo group:** If you are in this group, you will receive a placebo that matches SAR441566 for 12 weeks.

      The investigational medicinal product (SAR441566 or placebo) will be added to a background therapy of Methotrexate (MTX), which you should already be on as part of your current treatment for Rheumatoid Arthritis.

      4. **Post-Treatment Period (Safety Follow-up, 2 weeks ± 3 days):** After completing the treatment period, there will be a safety follow-up for 2 weeks to monitor any side effects or reactions to the treatment.

      5. **Scheduled Study Visits:** Throughout the study, from the run-in period to the post-treatment safety follow-up, you will have a total of 8 scheduled visits to the study site. These visits are crucial for monitoring your health, the effectiveness of the treatment, and any side effects.

      6. **Study Duration:** The overall duration of your participation in the study will be approximately up to 149 days, including all the periods mentioned above.

      It’s important to follow the study protocol closely and attend all scheduled visits to ensure your safety and the reliability of the study results.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have the following disease:

      1. Rheumatoid Arthritis: This is a chronic inflammatory disorder affecting many joints, including those in the hands and feet. In rheumatoid arthritis, the body’s immune system attacks its own tissue, including joints. In severe cases, it attacks internal organs. Rheumatoid arthritis can cause joint swelling, pain, and stiffness that may be more pronounced in the morning or after inactivity. Over time, the inflammation associated with rheumatoid arthritis can cause bone erosion and joint deformity.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Sure, here’s a simplified list of the conditions you must meet to join the study, with explanations for medical terms where necessary:

      1. Diagnosis of adult-onset Rheumatoid Arthritis (RA): You must have been diagnosed with RA according to the ACR/EULAR 2010 revised classification criteria. This means your RA started when you were an adult, and you meet specific criteria based on symptoms, blood tests, and sometimes imaging tests that doctors use to identify RA.
      2. Moderate-to-severely active RA: Your RA should be active and considered moderate to severe. This is determined if you have persistently active disease with ≥ 6 tender and ≥ 6 swollen joints and a high sensitivity C-reactive protein > 5 mg/L. C-reactive protein (CRP) is a substance your liver makes in response to inflammation. A higher CRP level suggests you have inflammation in your body, which is common in RA.
      3. Continuous treatment with Methotrexate (MTX) for at least 12 consecutive weeks prior to randomization: You must have been on a stable dose of Methotrexate, which is a common medication used to treat RA, for at least 12 weeks before you can join the study. The dose should be between 10 to 25 mg/week, or per local labeling requirements if different, and you should also be taking folic/folinic acid as part of your MTX regimen.
      4. Inadequate clinical response to MTX: Despite taking Methotrexate at the required dose, your RA symptoms have not improved enough according to local standards.
      5. Body Mass Index (BMI) within the range 18 – 35 kg/m^2: Your BMI, which is a measure of body fat based on your weight in relation to your height, must fall within this range to participate.

      These criteria are designed to select participants who have a specific level of disease activity and have been on stable treatment, but who are not responding adequately to their current medication. This helps ensure that the study can accurately assess the effects of the new treatment being tested.

      What Reasons Could Exclude Me from the Study?

      Sure, here’s a simplified list of conditions that would prevent you from taking part in the study:

      1. Immunologic disorder other than Rheumatoid Arthritis: If you have an immune system disorder that isn’t Rheumatoid Arthritis, except for secondary Sjogren’s syndrome (a condition often seen with autoimmune disorders, causing dry eyes and mouth) or controlled diabetes or thyroid disorder.
      2. Need for glucocorticoid therapy: If you require treatment with glucocorticoids, which are steroids used to reduce inflammation.
      3. Uncontrolled polymyalgia rheumatica or fibromyalgia: These are conditions that cause muscle pain and stiffness.
      4. Recent serious infection: If you’ve had a serious infection like pneumonia or septicemia (blood poisoning), or needed hospital treatment or IV antibiotics within the last 30 days.
      5. Significant immunosuppression: If you have a weakened immune system, either from a condition or treatment that lowers your body’s ability to fight infections.
      6. Heart failure or stroke: If you’ve had moderate-to-severe heart failure or a recent stroke.
      7. History of solid organ transplant: If you’ve received an organ transplant.
      8. Alcohol or drug abuse: If you’ve had issues with alcohol or drug abuse within the last 2 years.
      9. Demyelinating disease: Conditions that damage the protective covering of nerves, such as Multiple Sclerosis.
      10. Planned surgery: If you have any surgery planned during the study period.
      11. Severe disability: If you’re largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care ability.
      12. Recent vaccination with live vaccines: If you’ve had a live or live-attenuated virus vaccine within 6 weeks before joining the study.
      13. Active malignancy: If you have an active cancer or one in remission for less than 5 years, except for certain treated skin cancers or localized carcinoma in situ of the cervix or ductal breast.
      14. Previous or current use of certain RA medications: If you’ve used biologic therapy or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs) for RA.
      15. Use of high-dose oral glucocorticoids: If you’re taking more than 10 mg per day of prednisone or equivalent, or if the dosage changed within 4 weeks before screening.
      16. Use of parenteral glucocorticoids or intra-articular glucocorticoids: If you’ve used these within 4 weeks before screening.
      17. Change in dose for NSAIDs: If you’ve started or changed the dose of nonsteroidal anti-inflammatory drugs within 1 week before screening.
      18. Prior use of certain RA medications other than MTX: If you’ve used conventional disease-modifying anti-rheumatic drugs other than Methotrexate.

      These conditions are in place to ensure the safety of participants and the integrity of the study results.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      In this study, the following drugs are involved:

      1. SAR441566 – This is the investigational medicinal product being tested in the study. SAR441566 is a drug under investigation for its potential use in treating moderate-to-severe rheumatoid arthritis (RA) in adults. It is given to participants in different dose regimens to assess its efficacy and safety. The role of SAR441566 in this study is to determine its effectiveness in improving symptoms of RA when added to methotrexate therapy.
      2. Methotrexate (MTX) – Methotrexate is a disease-modifying antirheumatic drug (DMARD) that is commonly used in the treatment of rheumatoid arthritis. It helps to reduce inflammation and slow down disease progression. In this study, methotrexate serves as the background therapy for all participants, providing a standard treatment against which the effects of SAR441566 can be measured.
      3. Placebo – A placebo is a substance with no active therapeutic effect. It is used in clinical trials as a control to test the efficacy of new drugs. In this study, a placebo matching SAR441566 is given to a comparator group to assess the true effect of SAR441566 against no active treatment while maintaining the same background therapy of methotrexate.

      The main focus of the study is to evaluate the safety and efficacy of SAR441566 in comparison to placebo, all while participants continue their stable dose of methotrexate.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Certainly! Here’s a list of the substances participating in the clinical trial, along with a description of their familiarity in medicine and medical literature:

      1. SAR441566: This is an investigational medicinal product, which means it is currently being studied and is not yet known to medicine and medical literature as an approved treatment. Its efficacy and safety are being evaluated in this clinical trial for adults with moderate-to-severe rheumatoid arthritis.
      2. Methotrexate (MTX): Methotrexate is a well-known medication in medicine and medical literature, especially for its use in treating various types of cancer, autoimmune diseases, and as a disease-modifying antirheumatic drug (DMARD) in rheumatoid arthritis. It has been widely studied and used for decades.
      3. Placebo: A placebo is a substance with no therapeutic effect, often used as a control in clinical trials. While not an active medication, it is a critical component of clinical research to compare the effects of investigational drugs against no treatment.

      Study ID

      CT-EU-00115453

      Recruitment status

      Recruting new patients

      Start of the trial

      7 months ago

      Study phase

      Phase
      II

      Medicinal Product