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NCT07902492

PHASE2

Efficacy of Rituximab for Remission Maintenance in Patients With Primary Angiitis of the Central Nervous System: an Open-label, Randomized, Controlled Trial Comparing Systematic Rituximab Infusions and Azathioprine

Sponsor: Centre Hospitalier St Anne

View on ClinicalTrials.gov

Summary

MAINRIPAC is a multicenter, randomized, open-label controlled clinical trial evaluating the efficacy of rituximab versus azathioprine for maintenance of remission in patients with primary angiitis of the central nervous system (PACNS). Patients are randomized 1:1 to receive either rituximab or azathioprine and are followed for 24 months, with regular clinical and brain MRI assessments to evaluate disease relapse and treatment safety.

Official title: Efficacy of Rituximab for Remission Maintenance in Patients With Primary Angiitis of the Central Nervous System: an Open-label, Randomized, Controlled Trial Comparing Systematic Rituximab Infusions and Azathioprine"

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01-01

Completion Date

2032-01-01

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Primary Angiitis of the Central Nervous System (PACNS) in Remission

Interventions

DRUG

RUXIENCE®.

Participants assigned to the rituximab arm receive rituximab 1,000 mg by intravenous infusion on Day 0 and Day 14, followed by maintenance administrations at Month 6, Month 12, and Month 18. Treatment is administered according to the protocol and local standard procedures, with appropriate premedication and clinical monitoring before, during, and after each infusion.

OTHER

Brain MRI

Brain magnetic resonance imaging (MRI) is performed at baseline and at Months 6, 12, 18, and 24. Additional brain MRI examinations may be performed according to the patient's clinical course, particularly in the event of suspected relapse. MRI examinations are centralized for blinded review according to the study procedures.

DRUG

Azathioprine 50 MG

Participants receive oral azathioprine: * 2 mg/kg/day for 12 months * 1.5 mg/kg/day for 6 months * 1 mg/kg/day for 4 months Total azathioprine treatment duration: 22 months.

Inclusion Criteria: * Patient aged 18 years or older * Patients who have documented PACNS diagnosis * Diagnosis is made if the following criteria are met: * History or clinical findings of an acquired neurological deficit of unknown origin after a thorough initial basic assessment; Cerebral angiogram with classic features of vasculitis (alternating areas of smooth-wall segmental narrowing and dilatation of cerebral arteries, arterial occlusions affecting many cerebral vessels, absence of proximal vessel atherosclerosis or other recognized abnormalities), and/or abnormal findings on MRI and CSF profile consistent with PACNS; * Or CNS biopsy sample showing vasculitis; * And no evidence of systemic vasculitis or any other disorder to which the angiographic or pathological features could be secondary (e.g. atherosclerosis, reversible cerebral vasoconstriction syndrome…) * Diagnosis of PACNS validated by the study committee * Patients in remission after induction therapy * Use of an effective method of contraception for female participants of childbearing age. Women of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes. * Patient able to give written informed consent prior to participation in the study * Affiliation with a mode of social security Exclusion Criteria: * Patients with other vasculitis * Patients with severe cardiac failure * Patients with acute or chronic active infections * Patients with active or recent cancer (\< 5 years) * Pregnant women and lactation * Patients with hypersensitivity to a monoclonal antibody or biologic agent * Patients suspected not to be observant to the proposed treatments * Patients unable to give written informed consent prior to participation in the study * Patients under guardianship, conservatorship, or subject to a court-ordered restraint Administration récente d'un vaccin vivant atténué incompatible avec l'instauration du traitement de l'étude,

Clinical Research Directory

Efficacy of Rituximab for Remission Maintenance in Patients With Primary Angiitis of the Central Nervous System: an Open-label, Randomized, Controlled Trial Comparing Systematic Rituximab Infusions and Azathioprine

Summary

Key Details

Conditions

Interventions

Eligibility Criteria