Assessment of role of oral steroid sparing agent in prevention of relapse

Assessment of the utility of addition of oral immunosuppressant in pemphigus vulgaris PV patients receiving rituximab infusion RA protocol and oral prednisolone a pilot, randomized open-label trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/086074

Enrollment

Registered

2025-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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: Intravaenous rituximab(rheumatoid arthritis protocol, both groups) Patients will receive 2 doses of 1g RTX infusion, two weeks apart. Control Intervention1: rituximab with or

Eligibility

Inclusion criteria

Inclusion criteria: Consenting confirmed patients of active mucocutaneous PV of any severity, aged 18-70 years, of any gender, which are planned for rituximab therapy and admitted to the dermatology ward and daycare center, will be recruited.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women

Design outcomes

Secondary

Measure	Time frame
To compare the time to disease relapse between the two groupsTimepoint: 2 years	—

Primary

Measure	Time frame
proportion of relapsing patients in rituximab infusion (RA protocol) with oral prednisolone group versus rituximab, oral prednisolone, and oral immunosuppressant group during 2 years study periodTimepoint: baseline, 3months, remission, relapse	—

Countries

India

Contacts

Public ContactDr Shreya K

MD FAMS

sujay_khandpur@yahoo.com8296529521

Outcome results

None listed

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