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

Sponsor

Uprety Shraddha (Other)

Overall Status

Unknown status

CT.gov ID

NCT01974518

Collaborator

Postgraduate Institute of Medical Education and Research (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pemphigus	Drug: Rituximab and Cyclophosphamide IV	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rituximab Inj Rituximab 1 gram IV given on day 0 and day 15	Drug: Rituximab and Cyclophosphamide IV
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	Drug: Rituximab and Cyclophosphamide IV

Arm

Intervention/Treatment

Active Comparator: Rituximab

Inj Rituximab 1 gram IV given on day 0 and day 15

Drug: Rituximab and Cyclophosphamide IV

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

Drug: Rituximab and Cyclophosphamide IV

Outcome Measures

Primary Outcome Measures

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 [upto 9 months]
Primary outcome measures being Time taken for control of disease activity Time taken for achievement of partial remission Time taken for achievement of complete remission

Secondary Outcome Measures

Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab. [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.

Other Outcome Measures

To study the difference in relapse rate [upto 9 months]
to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups [upto 9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with the diagnosis of pemphigus based on clinical, histopathological and immunological features the following:
Refractory disease defined as continuing extension of old lesions, development of new lesion, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/day of prednisolone or its equivalent with or without the concurrent use of cyclophosphamide 2mg/kg/day for 12 weeks or azathioprine 2.5 mg/kg/day for 12 weeks. Patients who fail to respond to 6 DCP/DP are also considered as refractory disease.