Health Condition 1: L100- Pemphigus vulgaris
Conditions
Interventions
Intervention1: Prednisolone tapering starting at the end of the consolidation phase: Participants in this group will receive oral prednisolone at a starting dose of:
0.5 mg/kg/day for mild pemphigus
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients with pemphigus vulgaris 2. Treatment na ve or within 4 weeks of starting oral corticosteroid therapy 3. Mild to moderate disease
Exclusion criteria
Exclusion criteria: Patient not giving consent; Contraindication to oral steroids, rituximab or azathioprine; diagnosed case of osteoporosis (T score less than 2.5 on dexa scan); comorbidity or other treatment that affect bone health such as renal failure, hyperparathyroidism, chronic use of medications that affect bone health; pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the incidence of steroid-induced osteoporosis between the two groups using BMD assessed by DEXA scan andto compare the rate of remission of pemphigus vulgarisTimepoint: To compare the incidence of steroid-induced osteoporosis between the two groups using BMD assessed by DEXA scan at 0, 6 and 12 months andto compare the rate of remission of pemphigus vulgaris at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the biochemical markers of bone turnover (serum calcium, phosphorus, albumin, ALP, vitamin D3, PTH,CTX1 and P1NP) between the two groups.Timepoint: 0, 3, 6 and 12 months;To compare the time to achieve clinical remission on minimal therapy, and off therapy between the two groupsTimepoint: at 12 months;To compare the rate of relapse of disease in those who achieved remission between the two groups.Timepoint: at 12 months;To compare the total cumulative steroid dose administered for the current disease episode before and after initiation of tapering between the two groups.Timepoint: at 12 months;To assess the quality of life of patients using the Autoimmune Bullous Disease Quality of Life (ABQOL) and Pemphigus Oral Lesions Intensity Score (POLIS).Timepoint: At baseline and 12 months;6. To compare the rate of disease flare in those who achieved disease control, between the two groups.Timepoint: At 12 months | — |
Countries
India
Contacts
Public ContactDipankar De
Postgraduate Institute of Medical Education and Research
Outcome results
None listed