Recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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).
Step 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 trial?

9 criteria

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 trial?

3 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Responsive
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Azienda Ospedaliera Universitaria Di Cagliari
Monserrato, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

Abatacept

What is already known about the treatment

Abatacept – This medication is administered through an injection, typically given under the skin or directly into a vein. It is currently used in the treatment of rheumatoid arthritis and is well-documented in medical literature. Abatacept is primarily indicated for patients with rheumatoid arthritis to help reduce symptoms and slow disease progression. It works by interfering with the activity of T-cells, a type of immune cell, by blocking the CD80/CD86 proteins, which are necessary for T-cell activation. Abatacept is classified as a selective co-stimulation modulator, which helps in modulating the immune response.

Investigated diseases

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.