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Study on the Effectiveness and Safety of Abatacept Biosimilar (DRL_AB) and Methotrexate for Patients with Moderate to Severe Rheumatoid Arthritis

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying the treatment of rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will compare the effects of a proposed biosimilar called DRL_AB with an existing medication known as Orencia, both of which are given through an intravenous infusion. These treatments will be used alongside another medication called methotrexate, which is commonly used to manage rheumatoid arthritis.

The purpose of the study is to evaluate how effective and safe these treatments are, as well as to understand their impact on the immune system. Participants will receive either the biosimilar or Orencia, in addition to methotrexate, over a period of time. The study will monitor changes in the participants' condition, particularly focusing on improvements in joint pain and swelling, as well as any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The study aims to provide valuable information on whether the new biosimilar is as effective and safe as the existing treatment option, Orencia, for people with moderate to severe rheumatoid arthritis. This research could potentially offer more treatment choices for managing this chronic 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 treatment phase
Upon joining the study, the patient will begin treatment with methotrexate tablets. The dosage will be at least 15 mg per week, adjusted based on tolerance and specific country guidelines. This medication is taken orally.
The patient will also receive Orencia (abatacept) through an intravenous infusion. This is a solution prepared from a powder concentrate. The infusion is administered at the study site.
Step 2
Comparison treatment phase
The patient will be randomly assigned to receive either the proposed Abatacept biosimilar (DRL_AB) or continue with Orencia. Both are administered via intravenous infusion.
This phase aims to compare the effectiveness and safety of the biosimilar with the original medication.
Step 3
Monitoring and assessment
Throughout the study, the patient's condition will be monitored regularly. This includes assessing changes in disease activity using the DAS28-CRP score, which measures inflammation and joint symptoms.
Assessments will occur at baseline, Week 13, and Week 25 to evaluate the treatment's impact.
Step 4
Safety evaluations
The study will monitor for any adverse effects, including allergic reactions, infections, and other potential side effects.
Blood tests will be conducted to check for the presence of antibodies that might affect the treatment's effectiveness.
Step 5
Completion of study
The study is expected to conclude by January 2026. Upon completion, the patient's overall response to the treatment will be evaluated.
The patient will receive information about the study's findings and any implications for their ongoing treatment.

Who can join the trial?

10 criteria

Patients must provide a written informed consent, which means they agree to participate in the study after understanding all the details.
Patients should be able to follow all the study requirements.
Patients must be between 18 and 80 years old.
Patients should have had moderately to severely active **Rheumatoid Arthritis** for at least 6 months. This means they have swelling in at least 10 joints and tenderness in at least 12 joints, along with a specific level of a protein called **CRP** in their blood.
Patients must have been taking **MTX** (a medication) and folic acid for at least 3 months before starting the study. They should be on a stable dose of MTX for at least 4 weeks before joining the study.
Patients should not be taking other specific medications for Rheumatoid Arthritis, like **cDMARDs**, for at least 4 weeks before starting the study.
Patients should not be on **bDMARDs** (another type of medication) for at least 4 weeks before starting the study.
If patients are taking **glucocorticoids** (a type of steroid), they should not be taking more than 10 mg per day and should be on a stable dose for at least 6 weeks before joining the study.
If patients are taking **NSAIDs** (pain relief medications), they should be on a stable dose for at least 4 weeks before joining the study and not take them right before certain study visits.
Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after. Men must agree to use birth control methods and not donate sperm during the study and for 6 months after.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to similar medications.
Patients who are currently participating in another clinical trial.
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 received certain treatments for rheumatoid arthritis recently.
Patients who have a weakened immune system.
Patients who have had a recent surgery.

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Verified sites

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

Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Kliiniliste Uuringute Keskus OÜ
Responsive
Tartu, Estonia
North Estonia Medical Centre Foundation
Responsive
Tallin, Estonia

Trial locations

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Investigated drugs

DRL_AB
is a proposed biosimilar medication being tested for its effectiveness, safety, and ability to trigger an immune response in patients with moderate to severe rheumatoid arthritis. It is administered through an intravenous route and is being compared to an existing medication to see if it works as well.
Orencia®
is an existing medication used in the treatment of moderate to severe rheumatoid arthritis. It is given to patients through an intravenous route and is used in this study as a comparison to evaluate the new biosimilar medication.
Methotrexate
is a medication commonly used to treat rheumatoid arthritis. In this study, it is used in combination with either DRL_AB or Orencia® to assess the overall effectiveness of the treatment in reducing the symptoms of the disease.

What is already known about the treatment

Abatacept – This medication is administered intravenously and is used as an add-on treatment for patients with moderate to severe rheumatoid arthritis. It is currently being studied in clinical trials to compare its efficacy, safety, and immunogenicity with an existing treatment called Orencia. Abatacept works by interfering with the activation of T-cells, which are part of the immune system, thereby reducing inflammation and joint damage. It is classified as a selective co-stimulation modulator, which helps in managing autoimmune conditions like rheumatoid arthritis.

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 joint tissues, resulting in 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 knees, hips, and shoulders. As the condition advances, it may lead to joint deformity and loss of function. Rheumatoid arthritis can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.