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Comparision between immunomodulator drug (rituximab) and immunosuppressant drug (steroids) versus only steroids in blistering disorder of skin

Randomized controlled trial to compare the efficacy and safety of Rituximab infusion with systemic steroids versus only systemic steroids in Pemphigus group of disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017157
Enrollment
50
Registered
2019-01-18
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 and Systemic Steroids Versus only Systemic Steroids: Rituximab is a chimeric monoclonal antibody that targets the CD20 molecule on B-cells. IT IS FDA APPROVED IN MODERATE
however, there is limited data from the Indian subcontinent. Protocol for Rituximab : â?¢ Seperate IV line â?¢ Pre medications before 30 minutes of giving rituximab infusion: Inj. Dexona 2cc IV Inj.

Sponsors

GMERS Medical College and Hospital Sola
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of above 18 years and of any gender , who willing to sign written informed consent.

Exclusion criteria

Exclusion criteria: Any patient with active bacterial, viral, invasive fungal infections. HIV reactive patients. Any haematological dyscrasia/ Bleeding tendency. Patients with history of any severe drug reaction in past. Patients with metabolic disturbances, cardiac disorders. Pregnancy and lactation. Patients or relatives â?? not willing to sign written informed consent.

Design outcomes

Secondary

MeasureTime frame
study any side effects in both groups.Timepoint: From initiation of treatment to 4 months

Primary

MeasureTime frame
we will evaluate for cumulative dose of systemic steroids & time require to reach minimum dose (10 mg prednisolone daily) in each patients after 4 monthsTimepoint: Patients will be followed up: Weekly for 1 month Fortnightly for 4 months

Countries

India

Contacts

Public ContactDr Hinal Jasvantbhai Prajapati

GMERS Medical College and Hospital

drkbpatel66@gmail.com8141133101

Outcome results

None listed

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