Rituximab versus azathioprine for remission maintenance in patients with primary angiitis of the central nervous system – randomized controlled trial

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What is this study about?

The trial focuses on patients with primary angiitis of the central nervous system, a rare condition in which blood vessels in the brain become inflamed, leading to headaches, weakness, vision problems, or strokes. The main goal is to find out whether one medication can keep the disease in remission better than the standard treatment.

Two medicines are being compared: an intravenous infusion of rituximab, which is given through a vein to target immune cells, and oral tablets of azathioprine, a pill that also reduces immune activity. Participants will receive the assigned medication over a period of up to two years while doctors monitor their health.

During the study, participants will have regular clinic visits, blood tests, and brain scans using MRI with contrast dye to check for any new or worsening signs of disease. The study will track how long participants stay free of relapse and record any side effects or changes in medication over the 24‑month follow‑up.

1 randomization

after joining the study you will be assigned by the study team to one of two groups. the assignment is done randomly, so you will receive either the test medication or the comparison medication.

the group assignment determines which medication you will take for the next 24 months.

2 start of maintenance therapy

once you are assigned to a group, you will begin the maintenance therapy that is used to keep the disease in remission.

the therapy will continue for up to 24 months unless the study protocol requires a change.

3 medication administration

if you are assigned to the comparison group you will take azathioprine tablets. each tablet contains 160 mg of the active substance. the tablets are taken orally, usually once a day, as directed by the study staff.

if you are assigned to the test group you will receive rituximab by intravenous infusion. the infusion contains a total dose of 1000 mg of rituximab, prepared as a solution for infusion. the infusion is given in a clinical setting according to the schedule defined by the trial protocol.

4 regular follow‑up visits

throughout the 24‑month period you will attend scheduled visits with the study team. at each visit you will be asked about any new symptoms, side effects, and overall health.

the visits also include physical examinations and collection of blood samples to monitor safety and drug levels.

5 imaging and relapse monitoring

periodically you will undergo magnetic resonance imaging (mri) of the brain. the scans are used to look for new or worsening lesions that could indicate a relapse of the disease.

relapse is defined as the return or worsening of neurological symptoms that are linked to the underlying condition. any sign of relapse will be recorded by the study staff.

6 study completion

after 24 months of therapy the study period ends for you. final assessments are performed, including evaluation of disease status, functional outcome, and any adverse events that occurred during the trial.

the results will be used to compare the effectiveness of rituximab versus azathioprine for maintaining remission.

Who Can Join the Study?

  • Be at least 18 years old.
  • Have a confirmed diagnosis of primary angiitis of the central nervous system (PACNS), which means inflammation of the blood vessels in the brain and spinal cord.
  • The study’s review team must verify that the PACNS diagnosis is correct.
  • Be in remission (the disease is not actively causing symptoms) after the initial “induction” treatment that was used to bring the disease under control.
  • If you are a female who could become pregnant, you must use a reliable method of contraception (birth control) during the study.
  • Be able to read, understand, and sign a written informed consent form, indicating you agree to take part in the trial.
  • Have an active form of social security or health insurance that covers your medical care.

Who Cannot Join the Study?

  • Having any other type of vasculitis (inflammation of blood vessels) besides the study disease.
  • Having severe cardiac failure (the heart cannot pump blood well enough).
  • Having an acute or chronic active infection (a current infection or a long‑standing infection that is still active).
  • Having active or recent cancer (cancer that is currently present or was treated within the past five years).
  • Being pregnant or lactating (breast‑feeding).
  • Having hypersensitivity (allergy) to a monoclonal antibody or other biologic agent (lab‑made protein medicines).
  • Being thought not likely to follow the treatment plan as asked.
  • Being unable to sign a written informed consent form (the document that shows you agree to join the study).
  • Being under guardianship, conservatorship, or a court‑ordered restraint (someone else makes legal decisions for you).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Groupe Hospitalier Du Sud Ile De France Melun France

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Regional Universitaire De Nancy Nancy France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
GHU St Anne Psychiatrie et Neurosciences Paris France
Hospices Civils De Lyon Bron France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.09.2026

Trial locations

Investigated Drugs:

Azathioprine is an oral medication that weakens the immune system. In this study it is used as the standard treatment to help keep the disease under control after patients have been treated for the initial episode. By lowering the activity of the immune system, azathioprine aims to prevent new flare‑ups of the blood vessel inflammation in the brain.

Rituximab is a medication given by an intravenous infusion. It works by targeting a specific type of white blood cell (B‑cells) that are involved in the immune response. In the trial, rituximab is tested as a new option for maintenance therapy, with the goal of keeping the disease in remission and possibly working better than the standard azathioprine treatment.

Primary angiitis of the central nervous system – Primary angiitis of the central nervous system is a rare inflammatory disease that affects the blood vessels of the brain and spinal cord. It causes swelling and narrowing of these vessels, which can reduce blood flow. Over time, the inflammation may create new lesions that appear on brain scans. Patients may experience new or worsening neurological symptoms such as headaches, weakness, or coordination problems as the disease becomes active. The condition can also cause small strokes or bleedings when vessels are damaged. Without treatment, the inflammation can continue to spread and involve more vessels.

Trial ID:
2026-525394-39-00
Protocol code:
D25 – P043
Trial Phase:
Therapeutic exploratory (Phase II)

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