Study on Tocilizumab and Prednisolone for Arthritis Caused by Cancer Immunotherapy in Cancer Patients

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What is this study about?

This clinical trial is focused on studying a condition known as arthritis, which can develop in patients undergoing treatment for cancer with a type of therapy called immune checkpoint inhibitors. These inhibitors are used to help the immune system fight cancer but can sometimes lead to joint inflammation, resulting in arthritis. The study aims to compare the effectiveness and safety of two treatment approaches for this type of arthritis. One approach involves using a medication called tocilizumab, which is given as an injection, in combination with a short course of glucocorticoids, a type of steroid medication. The other approach uses glucocorticoids alone.

The purpose of the study is to determine if the combination of tocilizumab and glucocorticoids is more effective in controlling arthritis symptoms than glucocorticoids alone. Participants in the study will be randomly assigned to one of the two treatment groups. The study will last for a period of 12 weeks, during which participants will receive their assigned treatment. The effectiveness of the treatments will be assessed at various points, including at 16 weeks, to see how well the arthritis is being managed.

Throughout the study, participants will be monitored for any changes in their arthritis symptoms, as well as for any side effects from the treatments. The study will also look at other factors such as pain levels, general health, and quality of life. This research is important for finding better ways to manage arthritis caused by cancer treatments, potentially improving the quality of life for patients experiencing this condition.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. This is done to compare the effectiveness of two different treatments for arthritis caused by cancer immunotherapy.

2 treatment group assignment

If assigned to arm A, you will receive only glucocorticoids. These are medications that help reduce inflammation and are taken orally in the form of tablets.

If assigned to arm B, you will receive a combination of tocilizumab and glucocorticoids. Tocilizumab is given as an injection under the skin, while glucocorticoids are taken orally.

3 medication details

For arm A, you will take Prednisolon Pfizer tablets. The dosage and frequency will be determined by the study team based on your specific needs.

For arm B, you will receive RoActemra injections, which contain tocilizumab, along with Prednisolon Pfizer tablets. The dosage and frequency will be determined by the study team.

4 treatment duration

The treatment will last for up to 16 weeks. During this time, your response to the medication will be closely monitored.

5 monitoring and assessments

Throughout the trial, regular assessments will be conducted to monitor your arthritis symptoms and overall health. This includes measuring the Clinical Disease Activity Index (CDAI), which helps evaluate the severity of your arthritis.

Additional assessments may include questionnaires about your pain, general health, fatigue, functional status, and quality of life.

6 end of treatment evaluation

At the end of the 16-week treatment period, a final evaluation will be conducted to assess the effectiveness of the treatment you received. This will include a review of your arthritis symptoms and any changes in your condition.

Who Can Join the Study?

The person is willing and able to give informed consent to participate in the trial.
The person is 18 years or older on the day of signing the informed consent.
The person has cancer confirmed by a doctor and has developed arthritis (joint inflammation) as a side effect of treatment with immune checkpoint inhibitors (a type of cancer treatment). This includes those who have received one or two types of these treatments, or in combination with chemotherapy. All currently approved immune checkpoint inhibitors are allowed.
At least 2 joints are affected, and the CDAI score (a measure of arthritis activity) is greater than 10.
The person has an Eastern Cooperative Oncology Group/World Health Organization Performance Status (a measure of general well-being and ability to perform daily activities) of 0-1. A status of 2 is allowed if it is due to ongoing immune-related side effects.
People already taking glucocorticoids (a type of steroid medication) for arthritis can join if they have been on this treatment for no more than 1 week.
Women who can have children must have a negative pregnancy test at the start of the study.
Female participants must be either 1 year post-menopausal or willing to use highly effective contraception during the study and for 3 months after the last dose of the study medication. Acceptable forms of birth control include hormonal contraceptives, intrauterine devices, surgical sterilization, or having a vasectomized partner.

Who Cannot Join the Study?

Patients who do not have cancer confirmed by a tissue sample (histology) or cell study (cytology).
Patients who have not developed arthritis as a result of treatment with immune checkpoint inhibitors (a type of cancer treatment that helps the immune system fight cancer).
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Hopital Beaujon	Clichy	France
Uuyvgsc Uxywwxmyoo Hhodxhqp	Uppsala	Sweden
Hgjymoyh Uojvpwlgkexjvd Sbiewtjbjm &wghvaf Hsvumbs dr Hxgggukjbzt	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	16.01.2023
Sweden	Recruiting	16.01.2023

Trial locations

Investigated drugs:

Tocilizumab is a medication used in this trial to help manage arthritis that can be caused by cancer treatments known as checkpoint inhibitors. It works by blocking a specific protein in the body called IL-6, which is involved in inflammation. By blocking this protein, tocilizumab can help reduce the inflammation and pain associated with arthritis, potentially improving joint function and quality of life for patients.

Glucocorticoids are a type of steroid medication used in this trial to reduce inflammation and suppress the immune system. They are commonly used to treat a variety of inflammatory conditions, including arthritis. In this study, glucocorticoids are used either alone or in combination with tocilizumab to see which approach is more effective in controlling arthritis symptoms caused by cancer treatments.

Investigated diseases:

Eastern Cooperative Oncology Group performance status

Arthritis Induced by Immune Checkpoint Inhibitors – This form of arthritis occurs as a side effect of cancer treatment with immune checkpoint inhibitors. It involves inflammation of the joints, leading to pain, swelling, and stiffness. The condition can affect multiple joints and may vary in severity. Symptoms typically develop after the initiation of cancer therapy and can persist for varying durations. The progression of the disease can lead to decreased joint function and mobility. Management focuses on controlling inflammation and alleviating symptoms to improve quality of life.

Trial ID:

2022-501130-33-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Tocilizumab and Prednisolone for Arthritis Caused by Cancer Immunotherapy in Cancer Patients

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