Clinical Trial: Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone

Brief Summary:

Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality.

The treatment back-bone is based on prednisolone administration. There are controversies on the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid sparing drugs. For others, they are disease modifying drugs.

The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.


Detailed Summary:

The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

Official Title: Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Azathioprine in New Cases of Pemphigus Vulgaris Receiving Prednisolone

Randomized Double Blind Controlled Trial of Azathioprine versus Placebo in new cases of Pemphigus Vulgaris treated with Prednisolone

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Controlled, Parallel Assignment, Safety/Efficacy Study

Condition Intervention Phase Pemphigus Vulgaris Drug: Azathioprine Drug: Prednisolone Other: Placebo Phase II


Sponsor: Tehran University of Medical Sciences

Current Primary Outcome: • Disease activity index [ Time Frame: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months ]

Original Primary Outcome:

  • Disease activity scoring system based on a new system offered by Chams et al. [ Time Frame: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months ]
  • Had no new blisters within the previous month [ Time Frame: Throughout study; monthly for eleven months from month 2 ]


Current Secondary Outcome:

  • Total dose of corticosteroid [ Time Frame: At the end of study ]
  • Occurence of any adverse event [ Time Frame: Throughout study ]
  • Occurence of Grade 3 or higher treatment-related adverse event [ Time Frame: Throughout study ]
  • Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment [ Time Frame: Throughout study ]


Original Secondary Outcome:

  • Total dose of corticosteroid [ Time Frame: At the end of study ]
  • Occurence of any adverse event [ Time Frame: Throughout study ]
  • Occurence of Grade 3 or higher treatment-related adverse event [ Time Frame: Throughout study ]
  • serum levels of Dsg 1, Dsg 3 antibodies [ Time Frame: months 2 to 3 ]
  • Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment [ Time Frame: Throughout study ]


Information By: Tehran University of Medical Sciences

Dates:
Date Received: February 21, 2008
Date Started: January 2008
Date Completion:
Last Updated: November 26, 2010
Last Verified: November 2010