To assess by a randomised,pilot study which of the two treatment regimens i.e. Rituximab infusion or Dexamethasone pulse therapy is more efficacious in the treatment of pemphigus vulgaris and relationship of various immunological parameters in skin and blood

A randomized controlled pilot trial to compare the efficacy of Rituximab infusion versus intravenous Dexamethasone Pulse therapy in Pemphigus vulgaris and its correlation with phenotypic and functional determinants of B and T cells

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016531

Enrollment

Registered

2018-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: INTRAVENOUS INFUSION OF 2 DOSES, 1 g EACH AT DAY 1 AND 15. Control Intervention1: DEXAMETHASONE: Each pulse will consist of 3 days cycle of intravenous dexamethasone 100mg gi

Eligibility

Inclusion criteria

Inclusion criteria: Subject with active PV fulfilling any of the two criteria mentioned below: -Clinical signs typical of pemphigus vulgaris and -Histological features of suprabasal acantholysis on hematoxylin and eosin staining -Positive ELISA test for anti dsg1 and dsg3 antibodies 2. Patients giving consent for obtaining blood and skin biopsy samples for various investigations 3. Patients who can obtain i.v. Rituximab (1g 2 doses)

Exclusion criteria

Exclusion criteria: 1.Pure mucosal pemphigus vulgaris 2.Age 70 years 3.Has received prior biological therapy in past 2 months 4.Pregnant or lactating women. 5.Patients with severe renal or hepatic disease 6.Evidence of paraneoplastic pemphigus 7.Autoimmune blistering disease other than PV 8.Active, unhealed peptic ulcer within 3 months prior to randomization 9.Inherited or acquired immune deficiency 10.Malignancy, lymphoproliferative diseases or previous total lymphoid irradiation 11.Chronic or frequent drug resistant, bacterial infections or presence of severe active infection 12.Bone marrow insufficiency 13.Frequent and / or serious viral infections. 14.Systemic or invasive fungal disease within 2 years prior to randomization

Design outcomes

Primary

Measure	Time frame
Median time to achieve complete disease remission in Rituximab infusion versus intravenous Dexamethasone pulse therapy groupTimepoint: 24months	—

Secondary

Measure	Time frame
Clinical adverse events in both groups assessed in terms of causality, severity and seriousness Timepoint: 32months;Comparison of levels of circulating and lesional T-regulatory and B-regulatory cells between the 2 groups Timepoint: 32months;Cost effectiveness analysis between the two groups Timepoint: 32months;Cumulative dose of prednisolone in both groups Timepoint: 32months;Determination of biomarkers that would predict disease relapse in two groups: a) levels of BAFF and APRIL ligands and BAFF R, TACI and BCMA receptors to predict relapse of disease b) levels of CD4 T cells, CD19 B cell and anti desmoglein1 and desmoglein3 auto-antibodies in circulation Timepoint: 32months;Median time to achieve disease control in the 2 groups Timepoint: 24months;Median time to develop relapse in both groupsTimepoint: 32months;Number of patients in complete remission at 6 months and one yearTimepoint: 24months;Number of patients with relapse in both groups Timepoint: 32months;Percentage change in PDAI score and functional disability score Timepoint: 24months	—

Measure

Time frame

Clinical adverse events in both groups assessed in terms of causality, severity and seriousness Timepoint: 32months;Comparison of levels of circulating and lesional T-regulatory and B-regulatory cells between the 2 groups Timepoint: 32months;Cost effectiveness analysis between the two groups Timepoint: 32months;Cumulative dose of prednisolone in both groups Timepoint: 32months;Determination of biomarkers that would predict disease relapse in two groups: a) levels of BAFF and APRIL ligands and BAFF R, TACI and BCMA receptors to predict relapse of disease b) levels of CD4 T cells, CD19 B cell and anti desmoglein1 and desmoglein3 auto-antibodies in circulation Timepoint: 32months;Median time to achieve disease control in the 2 groups Timepoint: 24months;Median time to develop relapse in both groupsTimepoint: 32months;Number of patients in complete remission at 6 months and one yearTimepoint: 24months;Number of patients with relapse in both groups Timepoint: 32months;Percentage change in PDAI score and functional disability score Timepoint: 24months

—

Countries

India

Contacts

Public ContactDr SUJAY KHANDPUR

AIIMS, NEW DELHI

preeti.s1008@gmail.com8467997961

Outcome results

None listed

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