A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS
Overview
- Phase
- Phase 3
- Intervention
- Rituximab and Cyclophosphamide IV
- Conditions
- Pemphigus
- Sponsor
- Uprety Shraddha
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- 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
- Last Updated
- 11 years ago
Overview
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.
Investigators
Uprety Shraddha
Junior Resident
Post Graduate Institute of Medical Education and Research, Chandigarh
Eligibility 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.
Arms & Interventions
Rituximab
Inj Rituximab 1 gram IV given on day 0 and day 15
Intervention: Rituximab and Cyclophosphamide IV
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
Intervention: Rituximab and Cyclophosphamide IV
Outcomes
Primary Outcomes
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
Primary outcome measures being 1. Time taken for control of disease activity 2. Time taken for achievement of partial remission 3. Time taken for achievement of complete remission
Secondary Outcomes
- Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.(upto 9 months)