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Study on Maximizing Methotrexate Therapy for Patients with Active Rheumatoid Arthritis

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What is this trial about?

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

This clinical trial, known as the MethMax trial, is focused on studying the effects of a medication called methotrexate in patients with rheumatoid arthritis. Rheumatoid arthritis is a chronic condition that causes pain, swelling, and stiffness in the joints. The study aims to explore how different ways of taking methotrexate can help manage the symptoms of this disease. Methotrexate is a medication that can be taken as a tablet or as an injection. In this trial, participants will either continue taking methotrexate as a tablet or switch to an injection form to see which method is more effective in reducing disease activity.

The purpose of the study is to assess how well patients achieve remission, which means a significant reduction in disease symptoms, by the end of 24 weeks. Participants will be randomly assigned to one of two groups: one group will increase their methotrexate dose and switch from taking it orally to receiving it as an injection, while the other group will increase their dose but continue taking it orally. The study will monitor the participants' progress over a period of 24 weeks to determine which method of taking methotrexate is more effective in achieving remission.

Throughout the study, participants will have regular check-ups to assess their condition and any changes in their symptoms. The trial will also look at other factors, such as the overall activity of the disease and the participants' quality of life. By comparing the two groups, the study aims to provide valuable information on optimizing methotrexate treatment for people with rheumatoid arthritis, potentially leading to better management of the disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of rheumatoid arthritis, and current methotrexate treatment.
Participants must have been on a stable dose of oral methotrexate for at least three months.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current disease activity using the Clinical Disease Activity Index (CDAI).
This assessment includes a count of swollen and tender joints and may involve blood tests to measure inflammation markers.
Step 3
Randomization and treatment allocation
Participants are randomly assigned to one of two treatment groups.
One group will increase the oral methotrexate dose to 25 mg weekly, while the other group will switch to 25 mg methotrexate administered subcutaneously weekly.
Step 4
Treatment phase
The treatment phase lasts for 24 weeks.
Participants follow the assigned methotrexate regimen, either orally or subcutaneously, as per their group allocation.
Step 5
Mid-study assessment
At week 12, a mid-study assessment is conducted to evaluate disease activity and response to treatment.
This includes measuring CDAI, assessing joint counts, and possibly conducting additional blood tests.
Step 6
Final assessment
At the end of the 24-week period, a final assessment is performed.
The primary goal is to determine if remission, defined as a CDAI score of 2.8 or lower, has been achieved.
Secondary outcomes include evaluating low disease activity and response rates at various thresholds.
Step 7
Completion of study
Upon completion of the study, participants may be asked to provide feedback on their experience.
The study results will contribute to understanding the effectiveness of different methotrexate administration routes and dosages in managing rheumatoid arthritis.

Who can join the trial?

5 criteria

Men and women who are **18 years or older** and can understand and sign a consent form. This means they can read and understand the local language and follow the study steps.
Patients who have **rheumatoid arthritis** as defined by specific medical guidelines from 2010.
Patients who have been taking a medication called **methotrexate** by mouth, in doses between **10mg and 25mg weekly**, for at least **3 months**. The dose should be stable, and the patient should be able to handle this treatment well for at least **12 weeks**.
Patients with a **CDAI** (Clinical Disease Activity Index) score greater than **2.8** and at least **1 swollen joint** out of 28 joints checked.
Patients who are willing to **increase the methotrexate dose** and change how it is given, as per the study's requirements.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to medications similar to those used in the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain treatments for rheumatoid arthritis within a specific time frame before the study.
Patients who have been diagnosed with certain types of cancer.
Patients who have a history of certain blood disorders.
Patients who have had a recent surgery or are planning to have surgery during the study period.

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Verified sites

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

Verified
IRCCS Humanitas Research Hospital
Rozzano, Italy
Verified
Karolinska University Hospital
Solna, Sweden
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

Trial locations

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Investigated drugs

Methotrexate is a medication used in this trial to treat patients with active rheumatoid arthritis. It works by slowing down the immune system to help reduce inflammation and pain in the joints. The goal of using methotrexate in this study is to maximize its potential in achieving remission of the disease activity.

Methotrexate

What is already known about the treatment

Methotrexate – Methotrexate is typically administered orally or by injection and is used to treat rheumatoid arthritis. It is well-established in medical literature as a disease-modifying antirheumatic drug (DMARD). The main therapeutic indication for methotrexate is to reduce inflammation and slow the progression of rheumatoid arthritis. At the molecular level, methotrexate works by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis and cell replication, thereby reducing the proliferation of immune cells that cause inflammation. It is classified pharmacologically as an antimetabolite and immunosuppressant.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the small joints of the hands and feet. Over time, it can lead to joint damage and deformities. The disease may also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. It progresses through periods of flares and remissions, where symptoms can worsen or improve. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.