Overview

This trial is active, not recruiting.

Condition pemphigus
Treatment rituximab and cyclophosphamide iv
Phase phase 3
Sponsor Uprety Shraddha
Collaborator Postgraduate Institute of Medical Education and Research
Start date November 2013
End date June 2015
Trial size 20 participants
Trial identifier NCT01974518, 9187-PG-2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Active Comparator)
Inj Rituximab 1 gram IV given on day 0 and day 15
rituximab and cyclophosphamide iv
(Active Comparator)
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
rituximab and cyclophosphamide iv

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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. Exclusion Criteria: - Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis. - Abnormal liver function tests and renal function tests - Known cardiac arrhythmia or conduction abnormality - Systolic ejection fraction <40% - Pregnancy and breast feeding - Severely decreased bone marrow functions. - Known history of bladder cancer or hemorrhagic cystitis - Known allergy to cyclophosphamide - Patients of reproductive age group who haven't completed their family - Known hypersensitivity to murine proteins. - Patients who do not consent for the study.

Additional Information

Official title A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS
Principal investigator Shraddha Uprety, MBBS
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Postgraduate Institute of Medical Education and Research.