Recruiting

Study on Adjusting Tocilizumab Doses for Patients with Rheumatoid Arthritis

Verified siteRegistered 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 Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The treatment being tested is called Tocilizumab, which is given as a subcutaneous injection, meaning it is injected under the skin. Tocilizumab is also known by other names such as RO4877533 and BIIB800. The purpose of the study is to explore whether adjusting the dose of Tocilizumab based on the concentration in the blood is as effective as the standard dosing method.

Participants in the study will be randomly assigned to one of two groups. One group will continue receiving the standard dose of Tocilizumab, while the other group will have their dosing interval increased to every two weeks. The study will last for a total of 52 weeks, during which the participants' disease activity will be monitored. This will help determine if the adjusted dosing is as effective as the regular dosing in managing the symptoms of Rheumatoid Arthritis.

Throughout the study, various aspects will be observed, such as the difference in disease activity scores, the number of flare-ups, and any side effects experienced by participants. Additionally, the study will look at the cost differences between the two dosing methods and gather feedback from participants about their experience with the adjusted dosing. The goal is to find the most effective and efficient way to use Tocilizumab in treating Rheumatoid Arthritis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria, including a diagnosis of rheumatoid arthritis according to established guidelines, and current use of tocilizumab 162 mg weekly for at least six months.
Consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the Disease Activity Score in 28 joints, including the erythrocyte sedimentation rate (DAS28-ESR).
This score helps determine the current state of rheumatoid arthritis activity.
Step 3
Randomization
Participants are randomly assigned to one of two groups: continuation of the standard dose of tocilizumab or an increased dosing interval to every two weeks.
This randomization is crucial for comparing the effectiveness of different dosing strategies.
Step 4
Treatment phase
Participants receive tocilizumab through subcutaneous injection as per their assigned group.
The treatment phase lasts for 52 weeks, with regular monitoring of disease activity and drug levels.
Step 5
Mid-study evaluation
After 28 weeks, an evaluation is conducted to compare the mean time-weighted DAS28 between the two groups.
Additional assessments include the Clinical Disease Activity Index (CDAI), Simple Disease Activity Index (SDAI), and Health Assessment Questionnaire (HAQ) scores.
Step 6
Final assessment
At the end of 52 weeks, a final assessment is performed to evaluate the long-term effects of the dosing strategies.
This includes a comparison of disease activity scores, drug levels, and any adverse events experienced during the trial.
Step 7
Feedback and conclusion
Participants provide feedback on their experience with dose optimization and therapeutic drug monitoring.
The study concludes with an analysis of the data collected to determine the most effective dosing strategy for tocilizumab in treating rheumatoid arthritis.

Who can join the trial?

7 criteria

You must have **rheumatoid arthritis**, which is a condition that causes pain and swelling in the joints, diagnosed according to specific guidelines from 1987 or 2010.
You should currently be using a medication called **subcutaneous tocilizumab** at a dose of 162 mg every week, and you must have been using it for at least the last 6 months.
Your doctor, who specializes in treating joint problems, must believe that continuing with tocilizumab is beneficial for you.
There should be no changes in your treatment with **glucocorticoids** (a type of steroid medication) and **DMARDs** (disease-modifying antirheumatic drugs, like methotrexate) in the past three months.
You need to provide **written informed consent**, which means you agree to participate in the study after being fully informed about it.
Both men and women can participate in the study.
The study is open to adults, which generally means people aged 18 and older.

Who cannot join the trial?

9 criteria

Patients who do not have rheumatoid arthritis cannot participate. Rheumatoid arthritis is a condition that causes pain and swelling in the joints.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are taking medications that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have a known allergy to the study medication cannot participate.

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Reade revalidatie & reumatologie centrum te Amsterdam
Verified
Amsterdam, The Netherlands

Trial locations

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Investigated drugs

Tocilizumab is a medication used in this trial to treat rheumatoid arthritis. It works by blocking a specific protein in the body that causes inflammation and joint damage. The trial is investigating whether adjusting the dosing schedule of tocilizumab, based on the concentration of the drug in the blood, can be as effective as the standard dosing schedule.

Tocilizumab

What is already known about the treatment

Tocilizumab – Tocilizumab is administered as an injection, either 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. The main therapeutic indication for tocilizumab is to reduce inflammation and slow the progression of rheumatoid arthritis. It works by blocking the interleukin-6 receptor, which plays a role in the immune response and inflammation. Tocilizumab is classified as a monoclonal antibody and is part of the class of drugs known as immunosuppressants.

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 small joints of the hands and feet. Over time, the inflammation can lead to joint damage and deformities. The disease can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. Symptoms may vary in severity and can come and go, with periods of increased disease activity known as flares. The exact cause of rheumatoid arthritis is not fully understood, but it involves the immune system attacking the body's own tissues.