Study on Abatacept for Predicting Treatment Response in Patients with Early Rheumatoid Arthritis

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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 use a treatment called ORENCIA, which is an injection containing the active substance abatacept. This medication is designed to help manage the symptoms of rheumatoid arthritis by targeting specific proteins in the body that contribute to inflammation.

The purpose of the study is to see if certain markers in the body, known as CD80/CD86 biomarkers, can predict how well patients with early rheumatoid arthritis will respond to treatment with abatacept. Participants in the study will receive either the active medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for 16 weeks, during which participants will receive regular injections and attend scheduled visits to monitor their progress.

Throughout the study, researchers will assess changes in the participants’ condition using various measures, such as the Disease Activity Score and the American College of Rheumatology criteria. These assessments will help determine the effectiveness of the treatment in reducing symptoms and improving the quality of life for those with rheumatoid arthritis. The study aims to provide valuable insights into personalized treatment approaches for this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and routine laboratory tests.

Eligibility criteria include being an adult aged 18 or over, having a diagnosis of rheumatoid arthritis, and having symptoms for less than 12 months.

2 baseline evaluation

A baseline evaluation is performed to assess the current state of the condition. This involves measuring disease activity using the DAS28 score, which evaluates the number of swollen and tender joints, and other health indicators.

A synovial biopsy is conducted if there is at least one swollen joint with a minimum grade 2 synovial thickening.

3 treatment administration

The treatment phase involves administering the medication abatacept or a placebo. The medication is given as a subcutaneous injection using a pre-filled syringe containing 125 mg of solution.

Injections are administered according to the study schedule, which is designed to evaluate the response to the treatment over time.

4 follow-up visits

Regular follow-up visits are scheduled to monitor progress and assess the response to treatment. These visits include laboratory tests and evaluations of disease activity.

The primary endpoint is measured at 16 weeks, focusing on changes in the Clinical Disease Activity Index (CDAI).

5 final assessment

At the end of the study period, a final assessment is conducted to evaluate the overall effectiveness of the treatment.

Secondary endpoints include the percentage of patients achieving low disease activity, remission, and improvements in health-related quality of life measures.

Who Can Join the Study?

Adults, both female and male, aged 18 or over.
Willing and capable of giving informed consent, which means you understand the study and agree to participate.
Have a diagnosis of Rheumatoid Arthritis based on the 2010 ACR/EULAR classification criteria. This is a set of guidelines used by doctors to diagnose rheumatoid arthritis.
Have had symptoms for less than 12 months.
Have at least one swollen joint that can be used for a synovial biopsy. A synovial biopsy is a procedure where a small sample of tissue is taken from the joint lining.
Have moderate to severe disease activity, which means a DAS28 score greater than 3.2. DAS28 is a measure of how active the rheumatoid arthritis is.
Have not received any prior DMARD therapies. DMARDs are drugs used to treat rheumatoid arthritis.
Be considered a suitable candidate by the supervising clinician based on medical history, physical examination, vital signs, and routine laboratory tests.
Willing and able to attend scheduled visits, undergo laboratory tests, and follow other study procedures.

Who Cannot Join the Study?

Patients who do not have 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 are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
Azienda Ospedaliera di Padova	Padua	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Capkygrrc Uxlnnnhrjydnyr Sdnmwxvbw	Woluwe-Saint-Lambert	Belgium
Aqsfbcimn Uuk	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.11.2024
Italy	Recruiting	01.11.2024
Portugal	Recruiting	01.11.2024
Spain	Recruiting	01.11.2024
The Netherlands	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

Abatacept

Abatacept is a medication used in this trial to treat patients with early rheumatoid arthritis. It works by interfering with the immune system’s activity, specifically targeting certain proteins that contribute to inflammation and joint damage in rheumatoid arthritis. The trial aims to see if specific molecular markers in the body can predict how well a patient will respond to treatment with abatacept.

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. Over time, this inflammation can cause damage to the cartilage and bones within the joints. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees, hips, and shoulders. Symptoms typically include joint pain, swelling, stiffness, and reduced joint function. As the disease progresses, it can lead to joint deformities and loss of mobility.

Trial ID:

2024-511470-79-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Abatacept for Predicting Treatment Response in Patients with Early Rheumatoid Arthritis

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