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 - MAINRIPAC

Condition studied

Patients with primary angiitis of the central nervous system

Investigational medicinal product(s)

Eligibility

Primary endpoint

Time to relapse up to 24 months after initiation of maintenance therapy.

Endpoint detail

Proportion of participants without relapse at 12 and 24 months (see definition in section 4.1.1 of Protocol), Proportion of participants without clinical relapse (i.e. reoccurrence or worsening of any neurological symptoms attributable to active PACNS) at 12 and 24 months (see definition in section 4.1.1 of Protocol), Proportion of participants without “radiological relapse” (i.e. worsening of existing or evidence of new abnormal neuroimaging findings on MRI consistent with PACNS activity) at 12 and 24 months (see definition in section 4.1.1 of Protocol), Proportion of participants without evidence of new stroke lesion at 12 and 24 months, Proportion of participants without evidence of new contrast-enhanced lesions at 12 and 24 months, Proportion of participants without evidence of new or progressive intracranial stenosis at 12 and 24 months, Proportion of participants without evidence of progression ≥ 50% of preexisting intracranial stenosis at 12 and 24 months., Proportion of participants necessitating treatment change or escalation at 12 and 24 months, Proportion of participants with favorable outcome defined as mRS < 3 at 12 and 24 months, The SF-36 at 12 and 24 months, Prednisone dosage at 12 and 24 months, The number of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading system at 12 and 24 months, Proportion of death