CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors
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|ClinicalTrials.gov Identifier: NCT00400075|
Recruitment Status : Unknown
Verified November 2006 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting
First Posted : November 16, 2006
Last Update Posted : November 16, 2006
|Condition or disease||Intervention/treatment||Phase|
|Polyarteritis Nodosa Microscopic Polyangiitis||Drug: azathioprine Drug: cyclophosphamide||Phase 4|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients|
|Study Start Date :||July 1996|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400075
|Principal Investigator:||Jean-François Cordier, MD||Hospices Civils de Lyon|