European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Glucocorticoids

Criteria

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.