Effect of intralesional injection of rituximab in recalcitrant pemphigus lesions.
- Conditions
- pemphigus vulgaris.Pemphigus vulgaris
- Registration Number
- IRCT20141209020250N3
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
suffering from pemphigus vulrais, confirmed by clinical, histoligical and immunological criteria.
Skin or mucosal lesions with maximum diameter of 6 cm or 20 cm2 which are recalcitrant (means continued development of new lesions, continued extension of old lesions, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/d of prednisone equivalent with or without any of the following agents: cyclophosphamide 2 mg/kg/d for 12 weeks; azathioprine 2.5 mg/kg/d for12 weeks (if thiopurine s-methyltransferase level is normal); methotrexate 20 mg/wk for 12 weeks; or mycophenolate mofetil 3 g/d for 12 weeks.).
Insufficient response to three times intralesional injection of triamcinolone acetonide or topical super potent corticosteroid for at least 1 month.
no new lesion in recent 12 weeks.
no cardiac or infectious contraindication to rituximab.
oral steroid usage of <= 20 mg/d.
Patients with active lesions (expansion of previous old lesions or new lesions in recent 12 weeks).
Contraindications to rituximab (including hepatitis B, hepatitis C, progressive neurologic disease, angina, arrhythmia, herpes virus infection, CMV infection, acute pneumonia, renal diseases, lactation, hyperphosphatemia, hypocalcemia, hyperkalemia, anemia, low platelet or leukocyte count.
Injection of intravenous rituximab in recent 6 months.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti desmogline 1. Timepoint: baseline , 3 months , 6 months later. Method of measurement: blood sampling.;Anti desmogline 3. Timepoint: baseline , 3 months , 6 months. Method of measurement: blood sampling.;CD4 cell count. Timepoint: baseline , 15 day and 1 month later. Method of measurement: blood sampling.;CD19 cell count. Timepoint: baseline , 15 day and 1 month later. Method of measurement: blood sampling.
- Secondary Outcome Measures
Name Time Method Disease severity. Timepoint: before intervention and 1, 3, 6 months after intervention. Method of measurement: Pemphigus Disease Area Index (PDAI ).;Patient satisfaction. Timepoint: baseline, 1 month , 3 month , 6 month later. Method of measurement: Visual analyze scale.;Quality of life. Timepoint: baseline, 1 month , 3 month , 6 month later. Method of measurement: pemphigus quality of life questioner.;Size of lesion. Timepoint: baseline, 15 days , 1 month , 3 month , 6 month later. Method of measurement: ruler.