MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18) was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data). Right now, no randomized controlled study has been carried in order to evaluate the best duration of the maintenance treatment with rituximab. The investigators objective is to evaluate the efficacy of a long term rituximab treatment to prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase of rituximab maintenance treatment. The investigators will conduct a randomized placebo-controlled trial of a long term rituximab maintenance treatment (46 months) against a conventional maintenance treatment (18 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
500 mg rituximab infusion at the randomization visit and every 6 months for 18 months. Each infusion will be preceded by an infusion of 1000 mg paracetamol, 100 mg methylprednisolone and 5 mg dexchlorpheniramine.
Hopital cochin
Paris, France
Vasculitis score 2003 (BVAS 2003 )
Relapse free survival rates (BVAS \> 0)
Time frame: 28 months
Number of adverse events,
adverse events including infectious effects and their severity in each arm
Time frame: 28 months
number of patients experiencing at least one adverse event in both arms
Time frame: 28 months
correlation of ANCA level with the clinical events
Time frame: 28 months
ANCA level during follow-up
Time frame: 28 months
correlation B-Lymphocytes CD-19 level with the clinical events
Time frame: 28 months
B-Lymphocytes CD-19 level during follow-up
Time frame: 28 months
number of B memory cells during follow-up in both arms
Time frame: 28 months
correlation number of B memory cells with the clinical events
Time frame: 28 months
Number of patients with ANCA in each arm
Time frame: 28 months
Time frame to death in both arms
Time frame: 28 months
time frame of first minor relapse
Time frame: 28 months
time frame of first major relapse
"the reappearance of disease activity or worsening, with a Birmingham Vasculitis Activity Score \>0, and involvement of one or more major organs, disease-related life-threatening events, or both"
Time frame: 28 months
Cumulated dose of corticosteroid treatment
Time frame: 28 months
Number and severity of damages
Time frame: 28 months
number of of gammaglobulins
Time frame: 28 months
Quality of life : SF36 (The Short Form (36) Health Survey)
Time frame: 28 months
functional capacities : HAQ (Health Assessment Questionnaire )
Time frame: 28 months
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