A CLINICAL TRIAL TO COMPARE THE EFFECT OF LOW DOSE WITH CONVENTIONAL DOSE OF RITUXIMAB USED IN PATIENTS OF SEVERE PEMPHIGUS
Not Applicable
Completed
- Conditions
- Health Condition 1: L100- Pemphigus vulgarisHealth Condition 2: L100- Pemphigus vulgaris
- Registration Number
- CTRI/2018/10/015943
- Lead Sponsor
- DEPARTMENT OF DERMATOLOGY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
Inclusion Criteria
PATIENTS OF PEMPHIGUS VULGARIS OR PEMPHIGUS FOLIACEOUS IN THE ABOVE MENTIONED AGE GROUP WITH SIGNIFICANT CLINICAL DISEASE WITH PDAI( PEMPHIGUS DISEASE ACTIVITY INDEX) SCORE >15 AND WHO ARE WILLING FOR MONTHLY FOLLOW UP VISITS FOR 12 MONTHS.
Exclusion Criteria
PATIENTS WITH ACTIVE OR LATENT INFECTIONS LIKE HEPATITIS, TB OR SEPSIS.PREGNANT AND LACTATING FEMALES, PATIENTS WITH KNOWN CARDIAC ABNORMALITIES OR ARRHYTHMIA, SEVERELY DECREASED BONE MARROW FUNCTIONS, KNOWN HYPERSENSITIVITY TO MURINE PROTEINS OR ORAL CORTICOSTEROIDS. PATIENTS WHO HAVE RECEIVED RITUXIMAB IN PRECEDING 12 MONTHS OR DEXAMETHASONE PULSE THERAPY IN PRECEDING 3 MONTHS WILL ALSO BE EXCLUDED.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method COMPLETE REMISSION ON MINIMAL THERAPY AND COMPLETE REMISSION OFF THERAPY.Timepoint: COMPLETE REMISSION ON MINIMAL THERAPY AND COMPLETE REMISSION OFF THERAPY.
- Secondary Outcome Measures
Name Time Method IMMUNOLOGICAL RE POPULATION OF B LYMPHOCYTES OR CLINICAL RELAPSE OF THE DISEASETimepoint: MONTHLY VISITS FOR 12 MONTHS