Study on Methotrexate and Glucocorticoid Combination for Early Rheumatoid Arthritis, with Optional Etanercept for Non-Responders

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What is this study about?

This clinical trial is focused on studying the effectiveness of treatments for Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study involves a combination of medications, including Methotrexate, a commonly used drug for this condition, and a specific plan of glucocorticoids, which are a type of steroid medication. For patients who do not respond well to this initial treatment, the study explores the use of a medication called Etanercept, which is known to block a protein called tumor necrosis factor (TNF) that contributes to inflammation. The study also includes a medication called Leflunomide, which is taken orally and helps reduce joint damage and improve physical function.

The purpose of the study is to determine how effective these treatments are in helping patients achieve remission, which means reducing the symptoms of the disease to a minimal level. The study is designed to follow patients over a period of time to see how well they respond to the treatments. Initially, patients will receive the combination of Methotrexate and glucocorticoids. If they do not respond sufficiently, they may receive Etanercept for a period of up to 24 weeks. The study will monitor the patients’ progress and adjust treatments as needed to find the most effective approach for each individual.

Participants in the study will be observed over a long period to assess the safety and effectiveness of the treatments. This includes a follow-up phase where patients’ health and disease progression will be monitored for three years after the initial treatment phase. The study aims to provide valuable information on the best strategies for managing early Rheumatoid Arthritis and improving the quality of life for those affected by this condition.

1 initial treatment phase

The trial begins with the administration of a combination of Methotrexate and a step-down glucocorticoid regimen, known as COBRA-Slim. This phase aims to induce remission in patients with early rheumatoid arthritis.

During this phase, the effectiveness of the treatment is monitored. If the response is insufficient, defined as not achieving a specific score on a disease activity scale within 32 weeks, further steps are taken.

2 treatment adaptation

For patients who do not respond adequately to the initial treatment, an accelerated access to a six-month course of anti-TNF therapy is considered. The medication used is Etanercept, administered as a 50 mg solution for injection.

This treatment is given subcutaneously, which means it is injected under the skin. The timeframe for this treatment is from week 8 up to week 32.

3 long-term evaluation

The long-term effectiveness of the treatment is assessed over a period of 104 weeks. This involves monitoring the overall evolution of the disease burden, taking into account the speed and stability of the response.

The primary measure used is the area under the curve of a specific disease activity score, which reflects the patient’s condition over time.

4 extended follow-up

After completing the initial 104-week period, patients may participate in a long-term observational follow-up for three years. This phase evaluates the clinical course and safety of the treatments received during the trial.

The follow-up involves regular assessments to monitor the patient’s condition and any potential side effects of the treatments.

Who Can Join the Study?

Have a diagnosis of Rheumatoid Arthritis (RA) as defined by specific criteria for early RA. This means the condition has been identified using guidelines from medical organizations.
The RA diagnosis must have been made within the last year.
If you are a woman who can have children, you must use a reliable method of birth control, as evaluated in regular medical practice.
You must be able and willing to give written informed consent, which means you agree to participate in the study after understanding what it involves.
You need to understand and be able to write in Dutch or French.
For the long-term follow-up part of the study, you must have participated in a previous study called CareRA2020 RCT, completed a specific part of it, and be able and willing to give written informed consent for this follow-up.

Who Cannot Join the Study?

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 the study medication or similar drugs.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have been diagnosed with cancer in the past five years.
Patients who have a history of heart disease or uncontrolled high blood pressure.
Patients who have liver or kidney problems.
Patients who have a history of tuberculosis or have been in contact with someone with tuberculosis.
Patients who have received a live vaccine within the last month.
Patients who have a history of blood disorders or problems with blood clotting.
Patients who have a history of autoimmune diseases other than Rheumatoid Arthritis.
Patients who have had a major surgery within the last three months.
Patients who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
CHU Saint Pierre	Brussels	Belgium
Vrije Universiteit Brussel	Jette	Belgium
Grand Hopital De Charleroi	Charleroi	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Reumaclinic	Genk	Belgium
AZ St.-Elisabeth Herentals VZW	Herentals	Belgium
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Sint-Lucas General Hospital	Brugge	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Cazmkttwi Uofpumfumxbpub Selnwcmrt	Woluwe-Saint-Lambert	Belgium
Iuzfan	Bonheiden	Belgium
Ayryxygj Zgqoatvuze Jlh Pqdpzpmb	Vilvoorde	Belgium
Rfofz Idkeuxhmg Hkkjnaa	Hasselt	Belgium
Rzuqftyddseg Gmuf	Genk	Belgium
Oiabnfhilvtaobkawjfhqbkaiy	Aalst	Belgium
Rdiwhjvkq zirqzturbl Hgtrxs Hwyz Ljxchn	Leuven	Belgium
Uml Muiktrbfeahc	Yvoir	Belgium
Uunzwsrzxp Of Awbwvhh	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.06.2018

Trial locations

Investigated drugs:

Methotrexate is a medication used to treat rheumatoid arthritis by reducing inflammation and slowing down the progression of the disease. It is often used as a first-line treatment and works by suppressing the immune system to prevent joint damage.

Glucocorticoids are a type of steroid medication used in the COBRA-Slim regimen to quickly reduce inflammation and pain in patients with early rheumatoid arthritis. They help in achieving remission by controlling symptoms and preventing further joint damage.

Etanercept is a medication used in patients who do not respond adequately to the initial treatment. It is a type of anti-TNF therapy that helps reduce inflammation by blocking the tumor necrosis factor, a substance in the body that causes inflammation in rheumatoid arthritis.

Investigated diseases:

Rheumatoid arthritis

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 hands and feet. Over time, the inflammation can lead to joint damage and deformities. The disease can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The progression of rheumatoid arthritis can vary, with some people experiencing periods of remission and others having persistent symptoms. The exact cause of rheumatoid arthritis is not fully understood, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:

2023-510189-28-00

Protocol code:

S59474; KCE-16002

NCT ID:

NCT03649061

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Methotrexate and Glucocorticoid Combination for Early Rheumatoid Arthritis, with Optional Etanercept for Non-Responders

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?