Study on the Effectiveness and Tolerability of Oral vs. Subcutaneous Methotrexate for Patients with Early Rheumatoid Arthritis

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What is this study about?

This clinical trial is focused on studying the effectiveness and patient preferences for two forms of the medication methotrexate in treating rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will compare the use of methotrexate as a tablet taken by mouth and as a solution injected under the skin. Methotrexate is a common treatment for rheumatoid arthritis, and this study aims to understand which form of the medication patients prefer and how well each form works in managing the disease.

Participants in the study will be randomly assigned to receive either the oral or subcutaneous form of methotrexate. The study will last for up to 24 weeks, during which time participants will take the medication once a week. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The study will also gather information on the number of swollen and tender joints, overall pain levels, and general health as reported by the participants.

The goal of the study is to determine any differences in the disease activity score, known as DAS28, over a 12-month period between the two groups. This score helps to measure the severity of rheumatoid arthritis. Additionally, the study will look at other factors such as the number of participants who continue with their assigned treatment, any side effects experienced, and the overall satisfaction with the treatment. This information will help doctors understand which form of methotrexate might be more beneficial for patients with early rheumatoid arthritis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of rheumatoid arthritis according to the 2010 Rheumatoid Arthritis Classification Criteria.

Eligibility is verified, including age between 18-95 years and the indication for methotrexate treatment.

Women of childbearing capacity must have a negative pregnancy test and agree to use effective contraception during the trial. Male participants with fertile female partners must also use adequate contraception.

2 randomization and treatment allocation

Participants are randomly assigned to receive methotrexate either orally or subcutaneously.

The objective is to compare the effectiveness and tolerability of these two methods over a 12-month period.

3 treatment administration

Participants receive methotrexate according to the assigned method: orally or subcutaneously.

The dosage and frequency are determined by the study protocol and monitored by the healthcare team.

4 regular follow-up visits

Regular follow-up visits are scheduled to monitor the disease activity and treatment response.

The primary measure is the DAS28 score, which assesses disease activity.

Secondary measures include the number of swollen and tender joints, pain levels, general health, fatigue, and other health assessments.

5 data collection and monitoring

Data on medication use, including any changes in dosage or administration route, is collected.

Participants’ preferences and any side effects are recorded.

Additional health assessments, such as blood tests for inflammation markers like ESR and CRP, are conducted.

6 end of study evaluation

At the end of the 12-month period, a final evaluation is conducted to assess the overall effectiveness and tolerability of the treatment.

Participants’ experiences and preferences are documented to inform future treatment options.

Who Can Join the Study?

The person must have given written consent to participate in the study. This means they have agreed in writing to join the study.
The person must have a diagnosis of rheumatoid arthritis by a rheumatologist, which meets the 2010 Rheumatoid Arthritis Classification Criteria. A rheumatologist is a doctor who specializes in treating arthritis and other joint conditions.
The person must need treatment with methotrexate, a medication commonly used to treat rheumatoid arthritis.
The person must be between 18 and 95 years old.
Women who can have children must:
- Agree to use highly effective birth control methods during the study.
- Have a negative pregnancy test, meaning they are not pregnant at the start of the study.
Male participants with female partners who can have children must use adequate birth control in their relationship during the study.

Who Cannot Join the Study?

Patients who are not newly diagnosed with rheumatoid arthritis cannot participate. Rheumatoid arthritis is a condition where the body’s immune system attacks its own joints, causing pain and swelling.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who belong to a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Region Vaestmanland	Vasteras	Sweden

Other Sites

Site Name	City	Country
Region Oerebro Laen	Orebro	Sweden
Region Stockholm – SLSO	Stockholm	Sweden
Region Dalarna	Falun	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen	Skovde	Sweden
Malarsjukhuset Eskilstuna	Eskilstuna	Sweden
Region Vaesterbotten	Umea	Sweden
Region Halland	Varberg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	28.04.2022

Trial locations

Investigated drugs:

Methotrexate

Methotrexate (oral) is a medication used in this trial to treat patients with early rheumatoid arthritis. It is taken by mouth and works by reducing inflammation and slowing the progression of the disease. The trial aims to evaluate how effective and tolerable this form of methotrexate is for patients.

Methotrexate (subcutaneous) is another form of the same medication used in the trial, but it is administered through an injection under the skin. This method may offer different benefits or side effects compared to the oral form. The trial compares the effectiveness and patient preferences between the subcutaneous and oral forms of methotrexate.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with symptoms such as joint pain, swelling, and stiffness, often starting in the small joints of the hands and feet. As the disease progresses, it can lead to joint damage and deformities. The inflammation can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. Over time, rheumatoid arthritis can cause reduced joint function and mobility. The severity and progression of symptoms can vary widely among individuals.

Trial ID:

2024-512453-25-00

Protocol code:

MTXRA

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Tolerability of Oral vs. Subcutaneous Methotrexate for Patients with Early Rheumatoid Arthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?