Assessment of efficacy of combination of low dose rituximab & low dose prednisolone vs low dose prednisolone in inducing repeat remission in rituximab treated pemphigus vulgaris patients who develop disease relapse : A randomised controlled trial

PGIMER, Chandigarh0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

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•1. Patients of PV diagnosed with the following criteria:
•Compatible clinical picture and positive DIF with IgGÂ±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.

•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)

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