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Study on the Effects of Rituximab and Cyclophosphamide in Patients with ANCA Vasculitis

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What is this study about?

This clinical trial is focused on studying a condition called ANCA-associated vasculitis (AAV), which is a group of diseases that cause inflammation of blood vessels. The study is specifically looking at two types of AAV: granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). These conditions can affect major organs like the kidneys, lungs, and heart. The trial will explore the effects of two treatments: rituximab and cyclophosphamide. Rituximab is a medication that targets certain cells in the immune system, while cyclophosphamide is a chemotherapy drug that suppresses the immune system.

The purpose of the study is to compare the effectiveness of using rituximab alone versus a combination of rituximab and cyclophosphamide in maintaining remission, which means keeping the disease under control without symptoms. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to two years, during which the number of rituximab infusions needed to maintain remission will be evaluated. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, researchers will monitor various aspects, such as the time it takes for certain antibodies related to the disease to become undetectable, the duration of immune cell depletion, and any side effects experienced by participants. The study will also assess the quality of life and disease activity in participants. This information will help determine the best treatment approach for managing ANCA-associated vasculitis and improving patient outcomes.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and willingness to provide informed consent.

The study focuses on patients with a clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are types of ANCA vasculitis.

2 initial treatment phase

The initial treatment involves the administration of rituximab and possibly cyclophosphamide.

Rituximab is given as a solution for infusion, available in 100 mg and 500 mg concentrations.

Cyclophosphamide is provided as a powder for solution for injection or infusion, with a dosage of 500 mg.

3 treatment administration

Both medications are administered intravenously, meaning they are given directly into a vein.

The frequency and duration of administration are determined by the study protocol and the patient’s response to treatment.

4 monitoring and assessment

Throughout the study, the number of rituximab infusions needed to maintain clinical remission is monitored over a period of two years.

Regular assessments are conducted to evaluate the time to achieve a negative ANCA test and the duration of B-cell depletion.

5 safety and quality of life evaluation

Safety parameters are assessed, including any adverse events and infectious occurrences.

Quality of life is evaluated using patient-reported outcome scores, such as AAV-PRO and SNOT22.

6 study completion

The study is expected to conclude by June 2027, with ongoing assessments to ensure the effectiveness and safety of the treatment.

Who Can Join the Study?

  • Have a clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are specific types of ANCA vasculitis. These are conditions where the body’s immune system attacks its own blood vessels.
  • Be at least 18 years old and have either a newly-diagnosed or relapsed condition known as AAV (ANCA-associated vasculitis) that affects at least one major organ, such as the kidney, lung, heart, or nervous system. This condition requires treatment with medications like cyclophosphamide or rituximab.
  • Have a positive test for anti-PR3 or anti-MPO antibodies, which are specific proteins in the blood that help diagnose ANCA vasculitis. This can be a current or past test result.
  • Be willing and able to provide written Informed Consent, which means you understand the study and agree to participate, and be able to follow the study’s requirements.

Who Cannot Join the Study?

  • Patients who are not diagnosed with ANCA Vasculitis cannot participate. ANCA Vasculitis is a condition where the immune system attacks small blood vessels.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Amphia Hospital Breda The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Lighj Uvjlstwdkuej Mduwotq Clcxqjq (fhmcm Leiden The Netherlands
Akoqycion Ujg Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
03.05.2019

Trial locations

Investigated drugs:

Rituximab is a medication used in this trial to help manage a condition called AAV. It works by targeting specific cells in the immune system that are involved in causing inflammation and damage. The study is looking at how effective rituximab is in maintaining remission, which means keeping the disease under control without symptoms.

Cyclophosphamide is another medication being tested in combination with rituximab. It is used to suppress the immune system and reduce inflammation. The trial is comparing the effects of using cyclophosphamide together with rituximab versus using rituximab alone to see if the combination is more effective in treating AAV.

Investigated diseases:

ANCA Vasculitis – ANCA Vasculitis is an autoimmune disease characterized by inflammation of small blood vessels, which can lead to damage in various organs, most commonly the kidneys and lungs. The disease is associated with the presence of anti-neutrophil cytoplasmic antibodies (ANCAs) in the blood. Symptoms may include fatigue, fever, weight loss, and muscle or joint pain. As the disease progresses, it can cause more severe symptoms such as kidney dysfunction, respiratory issues, and skin rashes. The inflammation can lead to scarring and permanent damage to the affected organs if not managed. The course of the disease can vary, with periods of remission and flare-ups.

Trial ID:
2023-507868-39-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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