Health Condition 1: L100- Pemphigus vulgaris
Conditions
Interventions
Intervention1: Rituximab and prednisolone: Intravenous low dose rituximab (500mg, Single infusion) along with oral low dose prednisolone (0.3 mg per kilogram body weight, once daily)
Control Intervent
Sponsors
PGIMER, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of PV diagnosed with the following criteria: Compatible clinical picture and positive DIF with IgG±C3 in intercellular pattern in epidermis/ epithelium 2. Patients of PV who had been treated with rituximab (2 doses of 1g each, 2 weeks apart) for induction of immediate preceding remission who have disease relapse defined as â??Appearance of 3 or more new lesions in a month that do not heal spontaneously within 1-week in a patient who has achieved clinical remissionâ??. 3. Relapse duration less than 3 months 4. Patients with PDAI less than or equal to 45 (mild to moderate relapse) 5.Patient of age between 18-70 years. 6.Patients willing to come to PGIMER as per requirement of treatment protocol for follow up.
Exclusion criteria
Exclusion criteria: 1. Refusal to give consent. 2. Pregnant and lactating women. 3. Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis 4. Abnormal liver function tests and renal function tests 5. Known cardiac arrhythmias or conduction abnormalities 6. Women of reproductive age who have not completed their families and are not willing for contraception until 12 months after completion of rituximab infusion. 7. Severely decreased bone marrow function 8. Known hypersensitivity to murine proteins 9. Patients who have known contraindications for oral prednisolone (uncontrolled diabetes, uncontrolled hypertension, peptic ulcer disease, glaucoma, central serous retinopathy, steroid induced psychosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find out which of the treatment option between the combination of low dose rituximab & low dose prednisolone versus low dose prednisolone alone helps to achieve repeat remission in shorter time in relapsed pemphigus vulgaris patients who had been treated with standard rheumatoid arthritis protocol of rituximab for induction of preceding remissionTimepoint: We expect a difference of 4 weeks in obtaining remission between the two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of adverse effects between the groupsTimepoint: 9 months;Comparison of frequency of repeat relapse within the 9-month study periodTimepoint: 9 months;Comparison of total cumulative dose of prednisolone required in both armsTimepoint: 5 months;Proportion of patients in each group who achieve complete remission off therapyTimepoint: 7 months;Proportion of patients in each group who achieve complete remission on minimal therapyTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Ishita
PGIMER,Chandigarh
Outcome results
None listed