Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid

Phase 2

Completed

• Conditions: Bullous Pemphigoid

• Registration Number: NCT00431119
• Lead Sponsor: University Hospital Muenster

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 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.

Study Timeline

• Study Start: 1997-10
• Study Completion: 2000-10
• Status Verified: 2007-02
• Study First Submitted: 2007-02-02
• Study First Submitted QC: 2007-02-02
• Last Update Submitted: 2007-02-02
• Study First Posted: 2007-02-05
• Last Update Posted: 2007-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The cumulative total methylprednisolone doses and rate of remission.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures were safety profiles and duration of remission.

Trial Locations

Locations (11)

Dermatology, Univ. of Ulm; 🇩🇪 Ulm, Germany

Dermatology, Univ. of Wuerzburg; 🇩🇪 Wuerzburg, Germany

Dermatology, Univ. of Kiel; 🇩🇪 Kiel, Germany

Dermatology, Univ. of Dresden; 🇩🇪 Dresden, Germany

Dermatology, Medical Faculty Mannheim, Univ. of Heidelberg; 🇩🇪 Mannheim, Germany

Dermatology, Univ. Hospital Hannover; 🇩🇪 Hannover, Germany

Dermatology, Univ. of Cologne; 🇩🇪 Cologne, Germany

Dermatology, Univ. of Duesseldorf; 🇩🇪 Duesseldorf, Germany

Dermatology, Univ. of Goettingen; 🇩🇪 Goettingen, Germany

Dermatology, Univ. of Magdeburg; 🇩🇪 Magdeburg, Germany

Dermatology, Municipal Hospital Minden; 🇩🇪 Minden, Germany