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

3 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CHU Grenoble Alpes La Tronche France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Jean Rougier Cahors France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Bhyxmaql Ukxelklosx Hymxznti Closcm Besançon France
Iffbkxir dr Ceejnnrymvjc Hfcbkbxarfm Uutxgwggdtmlu dj Scaut Emfbezr (wrqsuqz Saint Priest En Jarez France
Hsktjfhx Upmakuivwkxnql Smlvdwaowv &eufmsg Hqruotl dj Hrjesuyjbcn STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
30.03.2016

Trial locations

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.

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.

Trial ID:
2024-516704-41-00
Protocol code:
6020
NCT ID:
NCT02714634
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • A Study of Cizutamig for Patients with Severe Autoimmune Inflammatory Diseases That Did Not Respond to Previous Treatments

    Recruiting

    1 1 1
    Germany
  • A long-term safety study of KYV-101 in patients previously treated for lupus nephritis, systemic sclerosis, myasthenia gravis, rheumatoid arthritis, or stiff person syndrome

    Recruiting

    4 1 1
    Investigated drugs:
    Germany