Clinical Trial: Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS

Brief Summary: The purpose of this study is to compare the effectiveness of rituximab alone vs combination of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to routine medications.

Detailed Summary:
Sponsor: Uprety Shraddha

Current Primary Outcome: Study the clinical efficacy of IV rituximab vs IV rituximab and IV cyclophosphamide combination for treatment of refractory pemphigus in terms of early and late end points as defined by the international pemphigus committee [ Time Frame: upto 9 months ]

Primary outcome measures being

  1. Time taken for control of disease activity
  2. Time taken for achievement of partial remission
  3. Time taken for achievement of complete remission


Original Primary Outcome: Same as current

Current Secondary Outcome: Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab. [ Time Frame: upto 9 months ]

Flowcytometric analysis of CD19+ve27-ve naïve B cells count, CD19+ve27+ve memory B cells count and CD24highCD38high transitional cell count will be performed at baseline, 3rd month, 6th month and 9th month.


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: October 4, 2013
Date Started: November 2013
Date Completion: June 2015
Last Updated: October 29, 2014
Last Verified: October 2014