NCT00431119

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 1997

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
Last Updated

February 5, 2007

Status Verified

February 1, 2007

First QC Date

February 2, 2007

Last Update Submit

February 2, 2007

Conditions

Bullous Pemphigoid

Keywords

bullous autoimmune diseasebullous pemphigoidimmunosuppressantscorticosteroidsmycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

  • The cumulative total methylprednisolone doses and rate of remission.

Secondary Outcomes (1)

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

Interventions

Azathioprine or Mycophenolate mofetilDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Dermatology, Univ. of Cologne

Cologne, 50931, Germany

Location

Dermatology, Univ. of Dresden

Dresden, 01307, Germany

Location

Dermatology, Univ. of Duesseldorf

Düsseldorf, 40225, Germany

Location

Dermatology, Univ. of Goettingen

Göttingen, 37075, Germany

Location

Dermatology, Univ. Hospital Hannover

Hanover, 30449, Germany

Location

Dermatology, Univ. of Kiel

Kiel, 24105, Germany

Location

Dermatology, Univ. of Magdeburg

Magdeburg, 39120, Germany

Location

Dermatology, Medical Faculty Mannheim, Univ. of Heidelberg

Mannheim, 68167, Germany

Location

Dermatology, Municipal Hospital Minden

Minden, 32423, Germany

Location

Dermatology, Univ. of Ulm

Ulm, 89081, Germany

Location

Dermatology, Univ. of Wuerzburg

Würzburg, 97080, Germany

Location

Related Publications (2)

  • 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.

    PMID: 17116835BACKGROUND

  • 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.

    PMID: 18087004DERIVED

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

AzathioprineMycophenolic Acid

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Stefan Beissert, MD

    Dermatology, Univ. of Muenster, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 5, 2007

Study Start

October 1, 1997

Study Completion

October 1, 2000

Last Updated

February 5, 2007

Record last verified: 2007-02

Locations

DE(11)