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Study on the Effectiveness and Safety of Tocilizumab and Methotrexate for Adults with Moderate to Severe Rheumatoid Arthritis

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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 two treatments: a proposed biosimilar called DRL_Tocilizumab and a reference product known as RoActemra. Both treatments are given as a solution for injection under the skin and are used alongside another medication called methotrexate, which is commonly used to treat rheumatoid arthritis.

The purpose of the study is to evaluate how effective and safe these treatments are for patients with moderate to severe rheumatoid arthritis. Participants will receive either the biosimilar or the reference product, and some may receive a placebo. The study will last for several weeks, during which participants will have regular check-ups to monitor their condition and any changes in their symptoms. The main goal is to see how the treatments affect the disease activity score, which measures the severity of rheumatoid arthritis symptoms.

Throughout the study, participants will be closely monitored for any side effects or reactions to the treatments. The study aims to provide valuable information on the potential benefits and risks of using the biosimilar compared to the reference product, helping to improve treatment options for people living with rheumatoid arthritis.

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
Joining the study
Upon joining the study, the patient will be assessed to ensure they meet the eligibility criteria. This includes having moderate to severe rheumatoid arthritis for at least 6 months and being on a stable dose of methotrexate (MTX) for at least 8 weeks prior to the study.
Step 2
Randomization and treatment initiation
The patient will be randomly assigned to receive either the proposed tocilizumab biosimilar (DRL_TC) or the reference product (RoActemra®).
Both medications are administered as a subcutaneous injection.
The patient will continue their current dose of MTX and folic acid throughout the study.
Step 3
Treatment administration
The patient will receive the assigned medication as an add-on to their existing MTX treatment. The specific dosage and frequency will be determined by the study protocol and the healthcare provider.
Step 4
Monitoring and assessments
The patient's response to the treatment will be monitored through regular assessments. These include measuring changes in disease activity using the DAS28-ESR score at various time points: baseline, week 5, week 9, week 13, week 17, week 21, and week 25.
Safety assessments will also be conducted to monitor any adverse effects or reactions to the treatment.
Step 5
Completion of the study
The study is expected to conclude by March 31, 2025. Upon completion, the patient's overall response to the treatment will be evaluated, and any necessary follow-up care will be provided.

Who can join the trial?

13 criteria

Must be a male or female aged between 18 and 80 years old.
Must be willing to provide informed consent to participate in the study.
Must have active moderate to severe rheumatoid arthritis for at least 6 months.
Must have at least 6 swollen joints and 8 tender joints.
Must have an erythrocyte sedimentation rate (ESR) of at least 28 mm/hour. ESR is a blood test that can show inflammation in the body.
Must have been on stable doses of methotrexate (MTX) for at least 8 weeks before joining the study. MTX is a medication used to treat rheumatoid arthritis.
Must be taking a stable dose of folic acid for at least 4 weeks before joining the study. Folic acid is a type of vitamin B that helps reduce side effects of MTX.
If taking other medications for rheumatoid arthritis, must have stopped them for a certain period before starting the study.
If taking glucocorticoids, must not be taking more than 10 mg per day and must be on a stable dose for at least 6 weeks before joining the study. Glucocorticoids are a type of steroid medication.
If taking NSAIDs (non-steroidal anti-inflammatory drugs), must be on a stable dose for at least 4 weeks before joining the study. NSAIDs are medications that reduce pain and inflammation.
Women who can have children must have a negative pregnancy test and agree to use reliable birth control during the study and for 6 months after. Men must agree to use birth control or be permanently sterile.
Must be able to self-administer the study treatment or have help from a caregiver.
Must be able to follow all study requirements according to the study doctor's opinion.

Who cannot join the trial?

1 criterion

Patients who have been previously exposed to JAK pathway inhibitors cannot participate. These are medications that affect certain proteins involved in the immune response.

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Verified sites

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

Verified
Clinicmed Daniluk Nowak Sp. k.
Bialystok, Poland
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Futuremeds Łódź
Lodz, Poland

Trial locations

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Investigated drugs

DRL_Tocilizumab
is a proposed biosimilar medication being tested for its effectiveness, safety, and ability to trigger an immune response in patients. It is used in the treatment of moderate to severe rheumatoid arthritis. This medication is administered by injection under the skin and is being compared to an existing treatment to see if it works just as well.
RoActemra
is a reference medication already used to treat moderate to severe rheumatoid arthritis. It is also given by injection under the skin. This medication helps reduce inflammation and pain in the joints by targeting specific proteins in the body that cause these symptoms.
Methotrexate
is a medication commonly used in combination with other treatments for rheumatoid arthritis. It helps to reduce inflammation and slow down the progression of the disease. Methotrexate is taken regularly to help manage symptoms and improve joint function.

Tocilizumab

What is already known about the treatment

Tocilizumab – Tocilizumab is administered subcutaneously and is currently being studied as a biosimilar to the reference product RoActemra®. It is used primarily for treating moderate to severe rheumatoid arthritis in adults who have not responded adequately to conventional disease-modifying antirheumatic drugs (cDMARDs) and are on stable doses of methotrexate. The medication works by inhibiting the interleukin-6 (IL-6) receptor, which plays a role in the inflammatory process associated with rheumatoid arthritis. Tocilizumab is classified as an immunosuppressive agent, specifically a monoclonal antibody targeting cytokines.

Investigated diseases

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, it can lead to joint damage and deformities. The disease progresses through periods of flares and remissions, where symptoms can worsen or improve. It can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.