Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

Official title:

A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431119
• Other study ID #: Beissert-BP#1
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2007
• Last updated: February 2, 2007
• Start date: October 1997
• Est. completion date: October 2000

Study information

• Verified date: February 2007
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.

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 0.5 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 0.5 mg per kg BW methylprednisolone once daily and 1,000 mg mycophenolate mofetil (CellCept® provided by Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany), given twice daily (2 g/d). 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 2.5 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 0.5 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 mg/d-steps every four weeks to 1,000 mg per day. From then on the mycophenolate mofetil dosage was decreased in 250 mg-steps every four weeks until discontinuation of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• clinical lesions suggestive of bullous pemphigoid

• subepidermal blistering upon histological analysis of skin biopsies

• linear deposition of IgG and C3 along the dermo-epidermal junction

• deposition of autoantibodies at the blister roof upon split-skin analysis

Exclusion Criteria:

• treatment with oral or topical corticosteroids, and other immunosuppressive drugs during the previous four weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

Drug:
• Azathioprine or Mycophenolate mofetil

Locations

Country	Name	City	State
Germany	Dermatology, Univ. of Cologne	Cologne
Germany	Dermatology, Univ. of Dresden	Dresden
Germany	Dermatology, Univ. of Duesseldorf	Duesseldorf
Germany	Dermatology, Univ. of Goettingen	Goettingen
Germany	Dermatology, Univ. Hospital Hannover	Hannover
Germany	Dermatology, Univ. of Kiel	Kiel
Germany	Dermatology, Univ. of Magdeburg	Magdeburg
Germany	Dermatology, Medical Faculty Mannheim, Univ. of Heidelberg	Mannheim
Germany	Dermatology, Municipal Hospital Minden	Minden
Germany	Dermatology, Univ. of Ulm	Ulm
Germany	Dermatology, Univ. of Wuerzburg	Wuerzburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Beissert S, Werfel T, Frieling U, Böhm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus. Arch Dermatol. 2006 Nov;142(11):1447-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative total methylprednisolone doses and rate of remission.
Secondary	Secondary outcome measures were safety profiles and duration of remission.