Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid

NCT ID: NCT00431119

Last Updated: 2007-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-10-31
• Study Completion Date: 2000-10-31

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.

Conditions

Bullous Pemphigoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Azathioprine or Mycophenolate mofetil

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Principal Investigators

Stefan Beissert, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Univ. of Muenster, Germany

Locations

Dermatology, Univ. of Cologne

Cologne, , Germany

Dermatology, Univ. of Dresden

Dresden, , Germany

Dermatology, Univ. of Duesseldorf

Düsseldorf, , Germany

Dermatology, Univ. of Goettingen

Göttingen, , Germany

Dermatology, Univ. Hospital Hannover

Hanover, , 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

Würzburg, , Germany

Countries

Germany

References

Beissert S, Werfel T, Frieling U, Bohm 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. doi: 10.1001/archderm.142.11.1447.

Reference Type: BACKGROUND

PMID: 17116835 (View on PubMed)

Beissert S, Werfel T, Frieling U, Bohm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Bonsmann G, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid. Arch Dermatol. 2007 Dec;143(12):1536-42. doi: 10.1001/archderm.143.12.1536.

Reference Type: DERIVED

PMID: 18087004 (View on PubMed)

Other Identifiers

Beissert-BP#1

Identifier Type: -

Identifier Source: org_study_id