Patients with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA, Wegener’s) or microscopic polyangiitis (MPA) , 12 months after initiation of treatment for vasculitis onset or flare, while being treated with rituximab (500 mg fixed low-dose) maintenance therapy every 6 months. Eligible patients are those in remission and receiving a prednisone dose of 5-10 mg/day, 12 months after vasculitis onset or flare, at the second rituximab maintenance infusion MedDRA version: 20.1 Level
Conditions
Interventions
Product Name: prednisone
Product Code: prednisone
Pharmaceutical Form: Capsule
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have been informed about the study and have given his/her written consent prior to participation in the study, - Patients with newly-diagnosed or relapsing MPA or GPA according to the ACR 1990 criteria and/or revised Chapel Hill Consensus Conference definition, independently of ANCA status, - Patients aged of 18 years or older, - Patients in remission (BVAS =0) for MPA or GPA achieved with rituximab or cyclophosphamide or methotrexate, - Patients who will all have already received glucocorticoids for 12 months ± 2 weeks after diagnosis or last flare before Day 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: - Patients with EGPA (Eosinophilic Granulomatosis with Polyangiitis) , 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 or recent cancer (<5 years) or myelodysplasia, except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment, - Pregnant women and lactation: women of childbearing potential will have to follow an effective method of contraception for the total duration of the study,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Relapse-free survival of patients continuing low-dose prednisone treatment until 13 months of treatment (Visit M13) versus those who will have prednisone treatment cessation after one month (visit M1), on remission maintenance with rituximab therapy, after achievement of remission of GPA or MPA, defined as survival of patients maintaining a BVAS (Birmingham Vasculitis Activity Score)=0 at Month 30 ;Secondary Objective: - To compare the rate of AE and SAE between Day 1 and Month 30, - To compare the rate of predefined severe events related to glucocorticoids between Day 1 and Month 30 including osteoporotic fracture and weight gain, - To compare the duration of complete remission, defined as the total accrued duration in weeks with BVAS=0 between Day 1 and Month 30, - To compare the rate of minor and major vasculitis relapse at Month 30, - To compare the side effect related to low dose prednisone by GTI toxicity scale between Day 1 and Month 30, - To compare the prednisone use between Day 1 and Month 30, - To compare the number of deaths between Day 1 and Month 30, ;Primary end point(s): relapse-free survival at Month 30 (18 months after last rituximab maintenance infusion), relapse being defined as BVAS >0.;Timepoint(s) of evaluation of this end point: Month 30 (18 months after last rituximab maintenance infusion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients with at least one AE between Day 1 and Month 30, - Percentage of patients with at least one minor or major vasculitis flare (BVAS>0) or one predefined severe event corresponding to AE of grade 3 to 5 of the Common Terminology Criteria, including severe side effect related to glucocorticoids (infection requiring hospitalization or intravenous antibiotics, osteoporotic fracture, diabetes requiring medication, cardiovascular event, osteonecrosis, psychiatric or mood disorder requiring drug administration, weight gain >10 kg), between inclusion Day 1 and Month 30, - Percentage of patients with at least one SAE between Day 1 and Month 30;Timepoint(s) of evaluation of this end point: Month 30 (18 months after last rituximab maintenance infusion) | — |
Countries
France
Contacts
Public ContactSylvie GALVAIN
Hospices Civils de Lyon
Outcome results
None listed