Comparing the Effects of High-Dose vs. Low-Dose Rituximab in Treating Pemphigus: A Study on Patient Outcomes

EVALUATING CLINICAL AND SEROLOGICAL OUTCOMES OF SINGLE HIGH(1000MG) VERSUS LOW DOSE (500MG) RITUXIMAB IN PATIENTS WITH PEMPHIGUS : A RANDOMIZED , COMPARATIVE STUDY - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084711

Enrollment

Registered

2025-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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: Rituximab (Single High Dose - 1000mg): Patients in this group (Group A) will receive a single intravenous infusion of rituximab 1000mg as per protocol. Standard pre-medications (antihis

Eligibility

Inclusion criteria

Inclusion criteria: 1) Confirmed cases of Pemphigus vulgaris or P. foliaceus diagnosed by histopathology, or direct immunofluorescence (DIF) or indirect immunofluorescence (IIF) -BIOCHIP 2) Active disease

Exclusion criteria

Exclusion criteria: 1)Active infections 2)cardiac arrhythmias 3)Ejection Fraction less then 4O % 4)Pregnancy 5)Serology positive [ HIV, Hepatitis B & C positivity]

Design outcomes

Primary

Measure	Time frame
Clinical evaluation: Response assessment by consensus statement formed by international pemphigus committee by Murrell et al, Pemphigus Disease Area Index (PDAI) , and Autoimmune Bullous Disease Quality of Life (ABQOL) in all patients once at baseline and at 6th month. Serological evaluation : Desmoglein 1 and Desmoglein 3 will be assessed in all patients once at baseline and at 6th month. ELISA indices were defined as positive (more than 20), borderline (10 20) and negative (less than 10). Timepoint: The follow-up period of 6 months is taken as the end point. The proportion of patients achieving early and late clinical response criteria, changes in PDAI, ABQOL and anti desmoglein titre estimation is taken into consideration.	—

Measure

Time frame

Clinical evaluation: Response assessment by consensus statement formed by international pemphigus committee by Murrell et al, Pemphigus Disease Area Index (PDAI) , and Autoimmune Bullous Disease Quality of Life (ABQOL) in all patients once at baseline and at 6th month. Serological evaluation : Desmoglein 1 and Desmoglein 3 will be assessed in all patients once at baseline and at 6th month. ELISA indices were defined as positive (more than 20), borderline (10 20) and negative (less than 10). Timepoint: The follow-up period of 6 months is taken as the end point. The proportion of patients achieving early and late clinical response criteria, changes in PDAI, ABQOL and anti desmoglein titre estimation is taken into consideration.

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Secondary

Measure	Time frame
The total cumulative steroid dose (TCD) will be recorded and compared between the groups.Timepoint: The follow-up period of 6 months	—

Countries

India

Contacts

Public ContactABHAY KRISHRAM RAI

PSG Institute of Medical Sciences and Research

kayemm57@gmail.com9443359014

Outcome results

None listed

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