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Completed

NCT Number: NCT00127764

European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus

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.

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Key information

Conditions

Pemphigus Autoimmune Diseases Immune System Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Dermatology, University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

About this study

Pemphigus is a severe chronic dermatological disease which appears to be incurable. Oral glucocorticoid now forms the cornerstone of treatment. From previous uncontrolled studies it has been suggested, that the use of high dose intravenous glucocorticoid pulse therapy may lead to complete remission without further therapy. Prospective placebo-controlled studies of adjuvant pulse therapy for pemphigus are lacking. This prospective, multi-centre, randomised, double-blind, placebo-controlled trial assesses the efficacy and steroid-sparing effect of oral high-dose glucocorticoid pulse therapy as adjuvant added to the standard combination therapy of prednisone and azathioprine in the treatment of pemphigus vulgaris, in terms of complete remission rate (primary endpoint), initial control, disease control, and adverse events. In the experimental arm glucocorticoid pulse therapy is given, comprising monthly pulses with 300mg oral dexamethasone on three consecutive days. In addition the patients receive daily prednisone and azathioprine treatment, the latter dose adjusted to the thiopurine-methyltransferase level. In the control arm the glucocorticoid pulse therapy is replaced double blindly by monthly oral placebo capsules on three consecutive days. in addition the patients receive the same daily combination schedule with prednisone and azathioprine as in the experimental arm. This study design requires 30 patients in each arm, with one year follow-up. Only new patients with pemphigus vulgaris and/or pemphigus oris are included.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New patients with diagnosis of pemphigus vulgaris

Exclusion criteria

  • Diagnosis of pemphigus different from vulgaris type
  • Current use of adjuvant treatment other than azathioprine. A wash out period of at least 2 weeks is required before inclusion is acceptable.
  • 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.

Treatment and study plan

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

Drug

Primary outcomes

  1. The rate of complete remission with pulse therapy

  2. Number of weeks in complete remission after 12 months

Secondary outcomes

  1. Time from start of pulse therapy until initial control

  2. Number of weeks in remission until 12 months

  3. Cumulative prednisolone use until 12 months

  4. Number of adverse events reported

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

European Randomised Placebo-Controlled Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus (Pempuls Trial)

Important dates

Study start
2001
Study completion
2005
First posted
Aug 8, 2005
Registry last updated
Aug 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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