In this study, I will compare the role of Rituximab 2000 mg vs Rituximab 200 mg in assessing the effectiveness in the management of Pemphigus

Comparison of efficacy of Rituximab, standard rheumatoid arthritis protocol (2 grams) vs ultra-low dose (200 mg) in the management of Pemphigus: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074507

Enrollment

Registered

2024-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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: 200 mg Injection Rituximab: 100 mg Injection Rituximab 100 mg, 2 doses 14 days apart Intervention2: Efficacy of Rituximab, 100 mg at 2 weeks apart in the management of Pemphigus: Random

Eligibility

Inclusion criteria

Inclusion criteria: Cases of Pemphigus (confirmed as Pemphigus on clinical features + Tzanck smear + Histopathological features± Direct immunofluorescence findings)

Exclusion criteria

Exclusion criteria: 1.Rituximab Infusion within past nine months 2.Dexamethasone- Cyclophosphamide Pulse therapy within past three months 3.Steroid sparing adjuvant immunosuppressants use within past four weeks 4.Paraneoplastic Pemphigus 5.Pregnancy or breastfeeding 6.Any known active systemic/ local infusion site local infections (Tuberculosis, HIV, viral hepatitis, Sepsis) 7.Any known hypersensitivity to the study molecules 8.Any contraindications to the study molecules

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Rituximab 2 gm vs Rituximab 200 mg in the management of Pemphigus in terms of:- 1.Based on PDAI and ABSIS scores 2. Based on VAS scale 3. Flow cytometric analysis of peripheral B cell marker CD19Timepoint: Baseline, 1 month, 3 month, 6 month and 9 months post Rituximab infusion	—

Secondary

Measure	Time frame
To compare the efficacy of Rituximab 2 gm vs Rituximab 200 mg in the management of Pemphigus in terms of:- 1. Relapse rate shall be calculated for each group (immunological and clinical) 2. Side effect profile 3. Cost analysis Timepoint: Baseline, 1 month, 3 month, 6 month and 9 months post Rituximab infusion	—

Countries

India

Contacts

Public ContactDr Raushan Kumar

All India Institute of Medical Sciences, Jodhpur

saurabhdoc@yahoo.co.in9968024250

Outcome results

None listed

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