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Study Comparing Methotrexate or Leflunomide with Targeted Therapy vs. Methotrexate or Leflunomide with Drug Combination for Rheumatoid Arthritis Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study is comparing two different treatment approaches for patients who have not responded well to certain medications. One approach involves using either Methotrexate or Leflunomide combined with a targeted therapy, which is a treatment designed to specifically target certain parts of the immune system. The other approach uses a combination of Methotrexate or Leflunomide with Sulfasalazine and Hydroxychloroquine, which are medications that help reduce inflammation.

The purpose of the study is to find out if the targeted therapies are more effective than the combination of the three medications. The study will last for about 12 months, during which participants will receive one of the treatment combinations. The medications being studied include Rituximab, Tocilizumab, Infliximab, Golimumab, Certolizumab Pegol, Sarilumab, Etanercept, Abatacept, Filgotinib, Upadacitinib, Adalimumab, Tofacitinib, Baricitinib, and a placebo. These medications are administered either orally, through an injection, or as an infusion.

Throughout the study, participants will be monitored to assess the effectiveness of the treatments and any side effects. The goal is to achieve low disease activity, which means reducing the symptoms of Rheumatoid Arthritis to a manageable level. The study will also track the occurrence of any serious side effects and measure the levels of the medications in the blood. This information will help determine the best treatment strategy for patients with Rheumatoid Arthritis who have not had success with initial treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of rheumatoid arthritis and ensuring an insufficient response to previous treatments such as methotrexate or leflunomide.
A blood test will be performed to check for specific markers and to ensure overall health status. This step ensures that the study is suitable for participation.
Step 2
Randomization
Participants will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the study treatments.
The first group will receive methotrexate or leflunomide combined with a targeted therapy. The second group will receive methotrexate or leflunomide combined with sulfasalazine and hydroxychloroquine.
Step 3
Treatment administration
Participants will begin their assigned treatment regimen. The medications will be administered either orally or through injections, depending on the specific drug.
The treatment duration is expected to last for at least 11 months, with regular monitoring and adjustments as needed based on response and any side effects.
Step 4
Regular follow-up visits
Regular follow-up visits will be scheduled at 3, 6, 9, and 12 months. During these visits, the effectiveness of the treatment will be assessed, and any side effects will be monitored.
Blood tests will be conducted to measure drug levels and to ensure safety. Participants will also complete questionnaires to evaluate their quality of life and disease activity.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted. This will include a comprehensive evaluation of disease activity and overall health.
The results will help determine the effectiveness of the treatment strategies and contribute to future research in managing rheumatoid arthritis.

Who can join the trial?

9 criteria

Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria. (These are guidelines used to diagnose rheumatoid arthritis.)
DAS28-CRP greater than 3.2. (This is a score that measures the activity of rheumatoid arthritis. A score above 3.2 indicates active disease.)
Insufficient response to methotrexate at a weekly dose of 15 mg or more after at least 3 months, or to leflunomide at a dose of 10 to 20 mg per day after 3 months of treatment. (These are medications used to treat rheumatoid arthritis.)
Presence of RA radiographic erosions and/or serum rheumatoid factor and/or anti-Cyclic Citrullinated Peptide (Anti-CCP). (These are tests and signs that help confirm the diagnosis of rheumatoid arthritis.)
Age 18 years or older.
Written informed consent, dated and signed before starting any trial-related procedure. (This means you agree to participate in the study and understand what it involves.)
Affiliation to a social insurance system. (This means you have health insurance coverage.)
Women of childbearing potential must have a negative β-HCG assay (blood test). (This is a test to confirm you are not pregnant.)
Use of an effective method of birth control during the study and continuing after stopping the study drug. The duration will depend on the drug used. (This is to prevent pregnancy during the study.)

Who cannot join the trial?

7 criteria

Patients who have a different condition than Rheumatoid Arthritis cannot participate.
Patients who are not in the age range of 18 to 65 years old cannot participate.
Patients who are not able to understand or follow the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of severe allergic reactions to the study medications cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
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Besançon, France
CHU Grenoble Alpes
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La Tronche, France
Centre Hospitalier Departemental Vendee
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La Roche sur Yon, France

Trial locations

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Investigated drugs

Methotrexate
is a medication commonly used to treat rheumatoid arthritis. It works by slowing down the immune system to help reduce inflammation and pain in the joints. This medication is often used when other treatments have not been effective.
Leflunomide
is another medication used to manage rheumatoid arthritis. It helps to reduce inflammation and slow the progression of the disease by suppressing the immune system. This can help improve joint function and reduce pain.
Sulfasalazine
is a medication that helps to reduce inflammation in the body. It is often used in combination with other drugs to treat rheumatoid arthritis, helping to relieve symptoms such as joint pain and swelling.
Hydroxychloroquine
is a medication that is used to treat rheumatoid arthritis by reducing inflammation and pain in the joints. It is often used in combination with other medications to improve its effectiveness in managing the symptoms of the disease.
Targeted Therapy
refers to a type of treatment that specifically targets certain parts of the immune system that are involved in causing inflammation and damage in rheumatoid arthritis. These therapies are designed to be more precise in their action, potentially leading to better outcomes for patients who do not respond well to traditional treatments.

What is already known about the treatment

Methotrexate
Methotrexate is typically administered orally in the form of tablets or as an injection under the skin. It is a well-established medication in the treatment of rheumatoid arthritis, widely discussed in medical literature. The main therapeutic use of methotrexate is to reduce inflammation and slow the progression of rheumatoid arthritis. At the molecular level, methotrexate works by inhibiting an enzyme involved in the growth of cells, which helps to reduce inflammation. It is classified as a disease-modifying antirheumatic drug (DMARD).
Leflunomide
Leflunomide is usually taken orally in tablet form. It is a recognized treatment for rheumatoid arthritis and is frequently mentioned in medical studies. The primary use of leflunomide is to alleviate symptoms and prevent joint damage in rheumatoid arthritis. It works by interfering with the production of immune cells that cause inflammation. Leflunomide is also classified as a disease-modifying antirheumatic drug (DMARD).
Sulfasalazine
Sulfasalazine is administered orally in tablet form. It is a well-known medication for treating rheumatoid arthritis and is often referenced in medical literature. The main therapeutic indication for sulfasalazine is to reduce pain and swelling in rheumatoid arthritis. It works by modulating the immune system to decrease inflammation. Sulfasalazine is classified as a disease-modifying antirheumatic drug (DMARD).
Hydroxychloroquine
Hydroxychloroquine is taken orally in tablet form. It is a commonly used medication for rheumatoid arthritis and is widely discussed in medical literature. The primary therapeutic use of hydroxychloroquine is to reduce inflammation and pain in rheumatoid arthritis. It works by affecting the immune system to decrease inflammation. Hydroxychloroquine is classified as a disease-modifying antirheumatic drug (DMARD).

Investigated diseases

Rheumatoid Arthritis – Rheumatoid Arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation of the synovial membrane, leading to swelling, pain, and stiffness in the joints. Over time, the inflammation can cause damage to the cartilage and bone within the joint, resulting in joint deformity and loss of function. The disease often progresses symmetrically, meaning it affects the same joints on both sides of the body. In addition to joint symptoms, it can also cause systemic effects, such as fatigue and fever. The progression of the disease can vary, with periods of increased activity (flares) and periods of remission.