Study on Sarilumab and Etanercept for Rheumatoid Arthritis in Patients Not Responding to csDMARD Therapy

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What is this study about?

This clinical trial is focused on studying Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study will explore the effectiveness of two treatments: Kevzara (sarilumab) and Enbrel (etanercept). Both medications are solutions for injection and are used to help reduce inflammation and pain in the joints.

The purpose of the study is to see if certain markers in the body, called biomarkers, can help predict how well a patient will respond to these treatments. This is particularly for patients who have not had success with previous treatments known as csDMARDs. The study will involve taking a small sample of tissue from a joint, known as a biopsy, to look for these biomarkers. This biopsy is done before starting the new treatment.

Participants in the study will receive either Kevzara or Enbrel or a placebo. The study will last for about 12 weeks, during which time the participants will have regular check-ups to monitor their response to the treatment. The main goal is to determine if the treatment helps reduce the symptoms of Rheumatoid Arthritis and to see if the biomarkers can predict this improvement.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of rheumatoid arthritis and previous treatment with csDMARDs for at least three months.

Informed consent is required before any procedures begin.

2 initial assessment

An initial assessment is conducted to evaluate the condition, including the Disease Activity Score (DAS) and the number of swollen joints.

A biopsy may be performed on a selected joint with synovial thickening.

3 treatment initiation

Treatment begins with biologic therapy, which may include Kevzara (sarilumab) or Enbrel (etanercept).

Kevzara is administered as a subcutaneous injection, available in 150 mg or 200 mg doses.

Enbrel is administered as a subcutaneous injection, available in a 50 mg dose.

4 treatment duration

The treatment continues for a period of 12 weeks.

Regular monitoring and assessments are conducted to evaluate the response to the treatment.

5 evaluation of treatment response

The primary endpoint is assessed at 12 weeks, determining if the treatment is effective using the American College of Rheumatology 50 (ACR-50) measure.

Secondary endpoints include the percentage of patients achieving low disease activity and changes in health assessment scores.

Who Can Join the Study?

Must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR classification criteria. These are guidelines used by doctors to diagnose Rheumatoid Arthritis.
Must have experienced csDMARD failure and be eligible for anti-TNF therapy according to EULAR recommendations. This means the patient has tried certain medications for at least 3 months without success and is now eligible for a different type of treatment.
Must have a DAS score greater than 5.1 and at least 3 swollen joints. DAS is a measure of how active the arthritis is. If undergoing a biopsy, the swollen joints should include the one selected for biopsy and two others.
The joint selected for biopsy must have at least grade 2 synovial thickening. This means the lining of the joint is thicker than normal, as checked during the biopsy visit.
Must be 18 years of age or older.
Must be capable of giving informed consent. This means the patient understands the study and agrees to participate before any screening procedures begin.
Must be willing and able to follow the scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who Cannot Join the Study?

Patients who have not been 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 for the study cannot participate. The study includes certain age groups, so it’s important to check if you fall within these groups.
Patients who are not starting on a biologic therapy after failing csDMARD therapy cannot participate. Biologic therapy is a type of treatment that uses substances made from living organisms to treat disease.
Patients who have not had a biopsy at presentation prior to any RA treatment cannot participate. A biopsy is a small sample of tissue taken from the body to be examined more closely.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Alwydzhfd Uex	Amsterdam	The Netherlands
Cetetrumh Uuqbnfjtdbfdyu Srbcwndxc	Woluwe-Saint-Lambert	Belgium
Ulujkbzedf Dkorz Slldu Dk Rhqg Li Sgvevlux	Rome	Italy
Hsawqehw Ufcgqoscveyjj dj A Cbnutm	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.06.2023
Italy	Recruiting	01.06.2023
Portugal	Recruiting	01.06.2023
Spain	Recruiting	01.06.2023
The Netherlands	Not yet recruiting	01.06.2023

Trial locations

Investigated drugs:

Anti-TNF is a type of biologic therapy used in the treatment of rheumatoid arthritis (RA). It works by blocking the tumor necrosis factor (TNF), a substance in the body that causes inflammation and is involved in the immune response. By inhibiting TNF, this medication helps reduce inflammation, pain, and joint damage in RA patients.

IL6 Inhibitor is another biologic therapy used for treating rheumatoid arthritis. It targets and blocks the interleukin-6 (IL-6) protein, which plays a role in the inflammation process. By reducing the activity of IL-6, this medication helps decrease inflammation and alleviate symptoms associated with RA, such as swelling and pain.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body’s own tissues, leading to inflammation in the joint lining. Over time, this inflammation can cause joint damage, pain, swelling, and stiffness. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the wrists, knees, and ankles. As it advances, rheumatoid arthritis can lead to joint deformity and loss of function. It may also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.

Trial ID:

2022-502021-18-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Sarilumab and Etanercept for Rheumatoid Arthritis in Patients Not Responding to csDMARD Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?