Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399399
Status:
UNKNOWN
Last Update Posted:
2006-11-14
First Post:
2006-11-13
Brief Title:
CHUSPAN SCS BP Treatment of Churg-Strauss Syndrome Without Poor-Prognosis Factors
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
CHUSPAN SCS BP Treatment of Churg-Strauss Syndrome Without Poor-Prognosis Factors a Prospective Randomized Study in 72 Patients
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the efficacy of systemic corticosteroids alone as first-line treatment of Churg-Strauss syndrome without poor-prognosis factors as defined by the five-factor score FFS0 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 mgkg at treatment start followed by oral prednisone 1 mgkgday 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 05 mgkg 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 2mgkgday or 6 cyclophosphamide pulses 06gm2 D1 D15 D30 then every 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 2mgkgday or 6 cyclophosphamide pulses 06gm2 D1 D15 D30 then every month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None