Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431119
Status:
COMPLETED
Last Update Posted:
2007-02-05
First Post:
2007-02-02
Brief Title:
Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid
Status:
COMPLETED
Status Verified Date:
2007-02
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:
To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid
Detailed Description:
This multicenter randomized non-blinded clinical trial compared two parallel groups of patients with bullous pemphigoid treated with oral methylprednisolone in combination with either azathioprine or mycophenolate mofetil Patients were randomly assigned irrespective of severity of disease to receive either 05 mg per kg body weight BW methylprednisolone Urbason Aventis Pharma Bad Soden Germany with 2 mg per kg BW azathioprine sodium Imurek GlaxoSmithKline Munich Germany once daily or 05 mg per kg BW methylprednisolone once daily and 1000 mg mycophenolate mofetil CellCept provided by Hoffmann-La Roche AG Grenzach-Wyhlen Germany given twice daily 2 gd The initial dose was maintained until blister formation ceased crusts as well as erosions disappeared and re-epithelialization of previous lesions started The corticosteroid dose was then sequentially reduced by 10 mg every two weeks until a dose of 20 mg per day was reached followed by a reduction in 5 mg-steps every two weeks until 10 mg per day Afterwards corticosteroid reduction was performed in 25 mg-steps every two weeks until zero After discontinuation of corticosteroids azathioprine or mycophenolate mofetil doses were maintained at the initial dosage as monotherapy for an additional 4 weeks Subsequently azathioprine was reduced by 05 mg per kg BW every four weeks to a dose of 100 mg per day Thereafter azathioprine was tapered in 25 mg-steps every four weeks until discontinuation of treatment Mycophenolate mofetil was reduced in 500 mgd-steps every four weeks to 1000 mg per day From then on the mycophenolate mofetil dosage was decreased in 250 mg-steps every four weeks until discontinuation of treatment
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