CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors
This trial is active, not recruiting.
|Conditions||polyarteritis nodosa, microscopic polyangiitis|
|Sponsor||Hospices Civils de Lyon|
|Start date||July 1996|
|Trial size||124 participants|
|Trial identifier||NCT00400075, 95.067/2|
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.
|Intervention model||parallel assignment|
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)
Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)
Male or female participants from 15 years up to 90 years old.
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
|Official title||CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients|
|Principal investigator||Jean-François Cordier, MD|
|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)|
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