Microscopic Polyangiitis, Polyarteritis Nodosa
Conditions
Keywords
Polyarteritis, Vasculitis, Therapy, Cyclophosphamide, Azathioprine
Brief summary
To assess the efficacy of systemic corticosteroids alone as first-line treatment of polyarteritis nodosa and microscopic polyangiitis without poor-prognosis factors as defined by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse.
Detailed description
All patients initially treated with systemic corticosteroids alone: optional IV methylprednisolone pulse (15 mg/kg) at treatment start followed by oral prednisone (1 mg/kg/day) according to a tapering schedule. Treating physicians allowed to treat minor relapses with corticosteroids without referring the patient for randomization, as long as the prednisone dose did not exceed 0.5 mg/kg for 1 month. Patients in whom prednisone doses could not be tapered below 20 mg, those who failed to enter remission and those who relapsed were randomized to receive either 6 months of oral azathioprine (2mg/kg/day) or 6 cyclophosphamide pulses (0.6g/m2 D1, D15, D30 then every month)
Interventions
DRUGazathioprine
DRUGcyclophosphamide
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Men and women with newly diagnosed polyarteritis nodosa or microscopic polyangiitis; * absence of poor prognostic factors as defined by the five-factor score (serum creatinine \> 140 μmol/l or 1.58 mg/dl, proteinuria \> 1 g/day, severe gastrointestinal tract involvement, specific cardiomyopathy and/or central nervous system involvement; * written informed consent. * Both genders eligible; * age ≥ 15 years.
Exclusion criteria
* age \< 15 years, previously treated systemic vasculitis; * history of cancer; * pregnant or breast-feeding women; * psychiatric disorders that might compromise compliance with therapy; * contraindication to study drug; * other ongoing therapeutic trial; * concomitant viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years) | — |
Countries
Switzerland
Outcome results
None listed