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

A randomized controlled trial to assess the effect of addition of azathioprine to prednisolone on duration of remission in patients of pemphigus vulgaris treated with rituximab.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022596
Enrollment
46
Registered
2020-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L100- Pemphigus vulgaris

Interventions

Intervention1: Azathioprine and predisolone: Azathioprine will be started at 50mg/day if there is no significant clinical, biochemicaland hematological side effects are seen , dose as per TPMT will be

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
time to relapseTimepoint: 15 months

Secondary

MeasureTime frame
proportion of patients achieving remission, time to clinical remission, duration of remission, side effects of treatment.Timepoint: 15 months

Countries

India

Contacts

Public ContactNeha Thakur

PGIMER

dr_dipankar_de@yahoo.in01722756562

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026