Study to assess additional effect of azathioprine in pemphigus vulgaris patient who are treated with rituximab.

Not Applicable

• Conditions: Health Condition 1: L100- Pemphigus vulgaris

• Registration Number: CTRI/2020/01/022596
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

Patient who has recently received 2 dose of rituximab 1gm, 2 weeks apart for moderate to severe pemphigus vulgaris or recalcitrant pemphigus vulgaris, Age more than 18 years,

Willing for regular follow up for 60 weeks at proposed intervals.

Exclusion Criteria

Individual upto 18 years of age, Inability to follow up till 60 weeks,Pregnant or lactating female,Elderly patient aged 80 years or older for practical difficulty in following up or unreliable patient,Significant anemia, leukopenia and thrombocytopenia,Reduced thiopurine methyl transferase activity,

Pre-existing liver disease/ chronic viral hepatitis/ transaminitis,Chronic infection or immunosuppressed state,History sugesstive of allergy to rituximab /azathioprine,Females planning to start family in next 60 weeks or not willing for contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time to relapseTimepoint: 15 months

Secondary Outcome Measures

Name	Time	Method
proportion of patients achieving remission, time to clinical remission, duration of remission, side effects of treatment.Timepoint: 15 months