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
- Conditions
- Health Condition 1: L100- Pemphigus vulgaris
- Registration Number
- CTRI/2018/12/016531
- Lead Sponsor
- DR SUJAY KHANDPUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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)
1.Pure mucosal pemphigus vulgaris
2.Age <18 or > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median time to achieve complete disease remission in Rituximab infusion versus intravenous Dexamethasone pulse therapy groupTimepoint: 24months
- Secondary Outcome Measures
Name Time Method