Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00431119
First received: February 2, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Bullous Pemphigoid
Drug: Azathioprine or Mycophenolate mofetil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • The cumulative total methylprednisolone doses and rate of remission.

Secondary Outcome Measures:
  • Secondary outcome measures were safety profiles and duration of remission.

Estimated Enrollment: 70
Study Start Date: October 1997
Estimated Study Completion Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431119

Locations
Germany
Dermatology, Univ. of Cologne
Cologne, Germany, 50931
Dermatology, Univ. of Dresden
Dresden, Germany, 01307
Dermatology, Univ. of Duesseldorf
Duesseldorf, Germany, 40225
Dermatology, Univ. of Goettingen
Goettingen, Germany, 37075
Dermatology, Univ. Hospital Hannover
Hannover, Germany, 30449
Dermatology, Univ. of Kiel
Kiel, Germany, 24105
Dermatology, Univ. of Magdeburg
Magdeburg, Germany, 39120
Dermatology, Medical Faculty Mannheim, Univ. of Heidelberg
Mannheim, Germany, 68167
Dermatology, Municipal Hospital Minden
Minden, Germany, 32423
Dermatology, Univ. of Ulm
Ulm, Germany, 89081
Dermatology, Univ. of Wuerzburg
Wuerzburg, Germany, 97080
Sponsors and Collaborators
University Hospital Muenster
Hoffmann-La Roche
Investigators
Principal Investigator: Stefan Beissert, MD Dermatology, Univ. of Muenster, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00431119     History of Changes
Other Study ID Numbers: Beissert-BP#1
Study First Received: February 2, 2007
Last Updated: February 2, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
bullous autoimmune disease
bullous pemphigoid
immunosuppressants
corticosteroids
mycophenolate mofetil

Additional relevant MeSH terms:
Pemphigoid, Bullous
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Skin Diseases, Vesiculobullous
Azathioprine
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014