A randomised trial to find out the better treatment option between a combination of low dose rituximab and low dose prednisolone versus low dose prednisolone alone in inducing repeat remission in pemphigus vulgaris patients who develop disease relapse

Not Applicable

Conditions: Health Condition 1: L100- Pemphigus vulgaris

Registration Number: CTRI/2023/06/053496

Lead Sponsor: PGIMER, Chandigarh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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