Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127764
Status:
COMPLETED
Last Update Posted:
2007-08-30
First Post:
2005-08-04
Brief Title:
European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
European Randomised Placebo-Controlled Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus Pempuls Trial
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
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:
By this study the investigators want to test if the value of adjuvant pulse glucocorticoid therapy for pemphigus can be determined by comparing an experimental arm dexamethasone pulse therapy prednisolone and azathioprine with a control arm placebo pulse therapy prednisolone and azathioprine The investigators will determine the rate of complete remission with dexamethasone pulse therapy the time needed for complete remission and the duration of remission and compare these data with those of the placebo arm
Detailed Description:
Pemphigus is a severe chronic dermatological disease which appears to be incurable Oral glucocorticoid now forms the cornerstone of treatment From previous uncontrolled studies it has been suggested that the use of high dose intravenous glucocorticoid pulse therapy may lead to complete remission without further therapy Prospective placebo-controlled studies of adjuvant pulse therapy for pemphigus are lacking This prospective multi-centre randomised double-blind placebo-controlled trial assesses the efficacy and steroid-sparing effect of oral high-dose glucocorticoid pulse therapy as adjuvant added to the standard combination therapy of prednisone and azathioprine in the treatment of pemphigus vulgaris in terms of complete remission rate primary endpoint initial control disease control and adverse events In the experimental arm glucocorticoid pulse therapy is given comprising monthly pulses with 300mg oral dexamethasone on three consecutive days In addition the patients receive daily prednisone and azathioprine treatment the latter dose adjusted to the thiopurine-methyltransferase level In the control arm the glucocorticoid pulse therapy is replaced double blindly by monthly oral placebo capsules on three consecutive days in addition the patients receive the same daily combination schedule with prednisone and azathioprine as in the experimental arm This study design requires 30 patients in each arm with one year follow-up Only new patients with pemphigus vulgaris andor pemphigus oris are included
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