Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid

February 2, 2007 updated by: University Hospital Muenster

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50931
        • Dermatology, Univ. of Cologne
      • Dresden, Germany, 01307
        • Dermatology, Univ. of Dresden
      • Duesseldorf, Germany, 40225
        • Dermatology, Univ. of Duesseldorf
      • Goettingen, Germany, 37075
        • Dermatology, Univ. of Goettingen
      • Hannover, Germany, 30449
        • Dermatology, Univ. Hospital Hannover
      • Kiel, Germany, 24105
        • Dermatology, Univ. of Kiel
      • Magdeburg, Germany, 39120
        • Dermatology, Univ. of Magdeburg
      • Mannheim, Germany, 68167
        • Dermatology, Medical Faculty Mannheim, Univ. of Heidelberg
      • Minden, Germany, 32423
        • Dermatology, Municipal Hospital Minden
      • Ulm, Germany, 89081
        • Dermatology, Univ. of Ulm
      • Wuerzburg, Germany, 97080
        • Dermatology, Univ. of Wuerzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The cumulative total methylprednisolone doses and rate of remission.

Secondary Outcome Measures

Outcome Measure
Secondary outcome measures were safety profiles and duration of remission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Stefan Beissert, MD, Dermatology, Univ. of Muenster, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Study Completion

October 1, 2000

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2007

Last Update Submitted That Met QC Criteria

February 2, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beissert-BP#1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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