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

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uprety Shraddha
• Collaborator: Postgraduate Institute of Medical Education and Research
• Treatments: Cyclophosphamide; Rituximab

Criteria

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.