Pemphigus
Conditions
Keywords
Pemphigus, Rituximab, Rituximab and IV cyclophosphamide combination, B cell re-population characteristics following Rituximab
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.
Interventions
DRUGRituximab and Cyclophosphamide IV
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Uprety Shraddha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
India
Outcome results
None listed