Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and
 microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood
 of disease control and temporary remission. However, most patients have recurrent relapses
 that lead to damage and require repeated treatment associated with long-term morbidity and
 death.

 Rituximab has been shown to be as effective as cyclophosphamide to induce remission and
 maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile .
 Although rituximab is becoming the standard of care for maintenance therapy in these
 patients, relapse still occurs and the optimal duration of prednisone therapy remains
 debated.

 On the one hand, most US studies use early withdrawal (6-12 months) because of feared side
 effects. On the other hand, most European trials propose late withdrawal (>18 months) given a
 lower observed relapse rate on long-term low dose glucocorticoids treatment.

 In a systematic review and meta-analysis, glucocorticoids regimen was the most significant
 variable explaining the variability between the proportions of ANCA-associated vasculitis
 patients with relapses. Nevertheless, it was an indirect estimation of treatment effect
 because of the absence of dedicated randomized trial. This meta-analysis concluded that
 combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids
 target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12
 months).

 The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was
 provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in
 patients with late prednisone withdrawal (18-24 months) and receiving rituximab as
 maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to
 withdraw glucocorticoids after 18 months was left to physician's discretion in this study and
 two thirds of the nonsevere relapses occurred when patients were off prednisone.

 The trial detailed here is the first prospective trial evaluating the length of
 glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.
Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and
 microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood
 of disease control and temporary remission. However, most patients have recurrent relapses
 that lead to damage and require repeated treatment associated with long-term morbidity and
 death.

 Rituximab has been shown to be as effective as cyclophosphamide to induce remission and
 maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile.
 Although rituximab is becoming the standard of care for maintenance therapy in these
 patients, relapse still occurs and the optimal duration of prednisone therapy remains
 debated.

 On the one hand, most US studies use early withdrawal (6-12 months) because of feared side
 effects. On the other hand, most European trials propose late withdrawal (>18 months) given a
 lower observed relapse rate on long-term low dose glucocorticoids treatment.

 In a systematic review and meta-analysis, glucocorticoids regimen was the most significant
 variable explaining the variability between the proportions of ANCA-associated vasculitis
 patients with relapses. Nevertheless, it was an indirect estimation of treatment effect
 because of the absence of dedicated randomized trial. This meta-analysis concluded that
 combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids
 target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12
 months).

 The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was
 provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in
 patients with late prednisone withdrawal (18-24 months) and receiving rituximab as
 maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to
 withdraw glucocorticoids after 18 months was left to physician's discretion in this study and
 two thirds of the nonsevere relapses occurred when patients were off prednisone.

 The trial detailed here is the first prospective trial evaluating the length of
 glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.
Inclusion Criteria:

 -  Patients with a diagnosis of MPA or GPA independently of ANCA status,

 -  Patient aged of 18 years or older,

 -  Patients with newly-diagnosed disease or relapsing disease at the time of screening,
 with an inactive disease defined as a BVAS = 0,

 -  Patients receiving maintenance infusion of rituximab 500 mg at 6 and 12 months after
 the start of vasculitis induction

 -  Patients receiving 5-10 mg/day of prednisone at screening,

 -  Patient able to give written informed consent prior to participation in the study.

 -  At Inclusion visit day, patient must be between 5 and 10 mg/day prednisone and at
 randomization visit day (D1), patient must be at 5 mg/day prednisone

 Exclusion Criteria:

 -  Patients with EGPA, or other vasculitides, defined by the ACR criteria and/or the
 Chapel Hill Consensus Conference,

 -  Patients with vasculitis with active disease defined as a BVAS >0,

 -  Patients with acute infections or chronic active infections (including HIV, HBV or
 HCV),

 -  Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma
 and prostatic cancer of low activity controlled by hormonal treatment,

 -  Pregnant women and lactation. Patients with childbearing potential should have
 reliable contraception for the all duration of the study,

 -  Patients with other uncontrolled diseases, including drug or alcohol abuse, severe
 psychiatric diseases, that could interfere with participation in the trial according
 to the protocol,

 -  Patients included in other investigational therapeutic study within the previous 3
 months,

 -  Patients suspected not to be observant to the proposed treatments,

 -  Patients who have white blood cell count ≤4,000/mm3,

 -  Patients who have platelet count ≤100,000/mm3,

 -  Patients who have ALT or AST level greater than 3 times the upper limit of normal that
 cannot be attributed to underlying MPA-GPA disease,

 -  Patients unable to give written informed consent prior to participation in the study.

 -  Patients with contraindication to use rituximab,