Study on Stopping Rituximab vs. Continuing Rituximab for Patients with ANCA-Associated Vasculitis in Stable Remission

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What is this study about?

This clinical trial is focused on studying a condition known as ANCA-associated vasculitis, which is a type of inflammation that affects blood vessels. The study is examining the effects of a medication called rituximab, which is often used to help manage this condition. The purpose of the study is to compare the outcomes of patients who continue using rituximab with those who stop using it, to see how it affects the likelihood of the disease returning.

Participants in the study will be randomly assigned to either continue with rituximab treatment or to discontinue it. The study will monitor the participants over a period of time to observe any changes in their condition, particularly focusing on whether the disease comes back. The study will also look at other factors such as kidney function, overall health quality, and any side effects experienced during the trial.

The trial aims to provide valuable information on the best approach to managing ANCA-associated vasculitis in patients who are in stable remission. By understanding the effects of continuing or stopping rituximab, the study hopes to improve treatment strategies for this condition.

1 joining the study

Upon joining the study, informed consent must be provided according to national regulations.

Eligibility includes a diagnosis of ANCA-associated vasculitis, either granulomatosis with polyangiitis or microscopic polyangiitis, with a history of PR3/MPO-ANCA positivity.

A stable remission for the last 24 months is required, with a minimum of 24 months of rituximab maintenance therapy completed, and the last dose administered at least 6 months prior to screening.

2 randomization

Participants are randomly assigned to either discontinue rituximab or continue with rituximab maintenance therapy.

The primary goal is to compare the relapse rate between these two groups.

3 treatment phase

For those continuing rituximab, the medication is administered via intravenous drip.

The dosage is either 500 mg or 1000 mg, based on previous treatment history.

4 monitoring and follow-up

Participants are monitored for disease relapse from the time of randomization.

Secondary outcomes include time to relapse, maintenance of remission at 24 and 36 months, serological response, kidney function, and health-related quality of life.

Regular assessments are conducted to evaluate these outcomes.

5 end of study

The study is estimated to conclude by December 31, 2029.

Final evaluations will include cumulative exposure to rituximab and glucocorticoids, as well as any adverse events experienced during the study.

Who Can Join the Study?

The patient must provide informed consent, which means they agree to participate in the study after understanding all the details and risks.
The patient must have a condition called ANCA-associated vasculitis (AAV), which includes types like granulomatosis with polyangiitis or microscopic polyangiitis, as defined by a specific medical conference.
The patient must currently have or have had a positive test for PR3/MPO-ANCA, which are specific antibodies, using a test called ELISA.
The patient must have been in a stable state of remission, meaning no active disease symptoms, for the last 24 months.
The patient must have received at least 24 months of Rituximab (RTX) maintenance therapy, with the last dose given at least 6 months before the study starts. Acceptable doses are 500 mg or 1000 mg given 6 months before joining the study.
Females who can become pregnant must agree to avoid pregnancy during the treatment with RTX and for 12 months after stopping RTX. They must have a negative pregnancy test at the start of the study and use effective birth control methods as advised by their doctor.

Who Cannot Join the Study?

Patients who are not in stable remission from ANCA-associated vasculitis. This means their condition is not currently under control.
Patients who have not been treated with rituximab. Rituximab is a medication used to treat certain autoimmune diseases.
Patients who are part of a vulnerable population. This refers to groups of people who may need special protection or care.
Patients who are outside the specified age range for the study. The study is only for certain age groups.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Oestergoetland	Linkoping	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Region Vaesterbotten	Umea	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Unrcpit Uhudndoezn Hycnfnnb	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.08.2024
Denmark	Not yet recruiting	01.08.2024
Germany	Not yet recruiting	01.08.2024
Ireland	Not yet recruiting	01.08.2024
Sweden	Recruiting	01.08.2024
The Netherlands	Not yet recruiting	01.08.2024

Trial locations

Rituximab is a medication used in this clinical trial to treat patients with ANCA-associated vasculitis, a condition that causes inflammation of blood vessels. The trial is investigating the effects of stopping rituximab treatment compared to continuing it as a maintenance therapy in patients who are in stable remission. The goal is to understand how discontinuing or maintaining the medication affects the relapse rate of the disease.

ANCA-associated vasculitis – This is a group of diseases characterized by inflammation of small blood vessels, often affecting organs such as the kidneys, lungs, and skin. The inflammation is associated with the presence of anti-neutrophil cytoplasmic antibodies (ANCA) in the blood. Symptoms can vary widely but often include fatigue, fever, weight loss, and organ-specific symptoms like kidney dysfunction or respiratory issues. The disease can progress with periods of remission and relapse, where symptoms may worsen or improve over time. It is considered a rare condition and can lead to significant organ damage if not managed properly.

Trial ID:

2023-508398-10-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Stopping Rituximab vs. Continuing Rituximab for Patients with ANCA-Associated Vasculitis in Stable Remission

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?