Phase 2
N=8
Rituximab in the Treatment of Patients With Bullous Pemphigoid
Bullous Pemphigoid
Bottom Line
View on ClinicalTrials.gov: NCT00286325 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Primary Safety Endpoint — 0; 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint |
0; 0; 1 | — |
| SECONDARY Number of Days to Cessation of New Blister |
57 | — |
| SECONDARY Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24 |
7 | — |
| SECONDARY IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24. |
40.5 | =0.0156 sig |
| SECONDARY B Cell Number at Week 24 |
3.99 | =0.0078 sig |
Summary
This study will determine the safety of treatment of bullous pemphigoid in patients resistant to therapy with systemic corticosteroids, with rituximab plus systemic corticosteroids.
Eligibility Criteria
Inclusion Criteria
- Patients with autoimmune blistering skin diseases with clinical, histologic and immunological criteria confirming the diagnosis of bullous pemphigoid
- Ongoing disease activity on 17.5 mg/day of prednisone or more
Exclusion Criteria
- Current use of other immunosuppressive therapy such as azathioprine, cytoxan or mycophenolate mofetil within the last 4 weeks.
Data sourced from ClinicalTrials.gov (NCT00286325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.