Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus
This trial is active, not recruiting.
|Treatment||rituximab and cyclophosphamide iv|
|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|
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|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver)|
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
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
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.
|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|
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