NCT00127764

Brief Summary

By this study, the investigators want to test if the value of adjuvant pulse glucocorticoid therapy for pemphigus can be determined by comparing an experimental arm (dexamethasone pulse therapy, prednisolone, and azathioprine) with a control arm (placebo pulse therapy, prednisolone, and azathioprine). The investigators will determine the rate of complete remission with dexamethasone pulse therapy; the time needed for complete remission; and the duration of remission, and compare these data with those of the placebo arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

January 1, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
Last Updated

August 30, 2007

Status Verified

August 1, 2004

First QC Date

August 4, 2005

Last Update Submit

August 29, 2007

Conditions

Pemphigus

Keywords

pemphigusdexamethasoneglucocorticoidspulsetherapyrandomisedplacebo-controlled

Outcome Measures

Primary Outcomes (2)

  • The rate of complete remission with pulse therapy

  • Number of weeks in complete remission after 12 months

Secondary Outcomes (4)

  • Time from start of pulse therapy until initial control

  • Number of weeks in remission until 12 months

  • Cumulative prednisolone use until 12 months

  • Number of adverse events reported

Interventions

dexamethasone (50mg 1dd6, 3 consecutive days/month)DRUG

Eligibility Criteria

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

You may qualify if:

  • New patients with diagnosis of pemphigus vulgaris

You may not qualify if:

  • Diagnosis of pemphigus different from vulgaris type
  • Presence of contra-indications for the use of high dose steroids
  • No availability for follow-up.
  • Concomitant diseases treated with oral steroids.
  • Glucocorticoids administered for pemphigus vulgaris longer than two months.
  • Presence of contra-indications for the use of azathioprine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (5)

  • Toth GG, van de Meer JB, Jonkman MF. Dexamethasone pulse therapy in pemphigus. J Eur Acad Dermatol Venereol. 2002 Nov;16(6):607-11. doi: 10.1046/j.1468-3083.2002.00413.x.

    PMID: 12482045BACKGROUND

  • Toth GG, Westerlaken BO, Eilders M, Laseur M, Jonkman MF, Uges DR. Dexamethasone pharmacokinetics after high-dose oral therapy for pemphigus. Ann Pharmacother. 2002 Jun;36(6):1108-9. doi: 10.1345/aph.1A047. No abstract available.

    PMID: 12058710BACKGROUND

  • Toth GG, Kloosterman C, Uges DR, Jonkman MF. Pharmacokinetics of high-dose oral and intravenous dexamethasone. Ther Drug Monit. 1999 Oct;21(5):532-5. doi: 10.1097/00007691-199910000-00007.

    PMID: 10519450BACKGROUND

  • Toth GG, Jonkman MF. Therapy of pemphigus. Clin Dermatol. 2001 Nov-Dec;19(6):761-7. doi: 10.1016/s0738-081x(00)00190-5. No abstract available.

    PMID: 11705686BACKGROUND

  • Mentink LF, Mackenzie MW, Toth GG, Laseur M, Lambert FP, Veeger NJ, Cianchini G, Pavlovic MD, Jonkman MF. Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris: PEMPULS trial. Arch Dermatol. 2006 May;142(5):570-6. doi: 10.1001/archderm.142.5.570.

    PMID: 16702494RESULT

MeSH Terms

Conditions

Pemphigus

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Marcel F Jonkman, MD, PhD

    Department of Dermatology, University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 8, 2005

Study Start

January 1, 2001

Study Completion

April 1, 2005

Last Updated

August 30, 2007

Record last verified: 2004-08

Locations

NL(1)