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

Sponsor
Uprety Shraddha
Study ID
NCT01974518
Phase
PHASE3
Status
Unknown

Conditions

  • Pemphigus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2013
Status verified
Oct 2014
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab
    Inj Rituximab 1 gram IV given on day 0 and day 15
  • Active Comparator: Combination of Rituximab and Cyclophosphamide IV
    IV Rituximab 1gram on day 0 and 15 750 mg IV cyclophosphamide in 250 ml of NS over 2-3 hr on day 1 and day 16

Primary Outcome Measure

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 ]