Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286325
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2006-02-01
Brief Title:
Rituximab in the Treatment of Patients With Bullous Pemphigoid
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Rituximab in the Treatment of Patients With Bullous Pemphigoid
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Bullous pemphigoid BP is an autoimmune blistering disease characterized clinically by the presence of severely itchy tense blisters located over the trunk and extremities BP is the most common of the autoimmune blistering diseases with an incidence of approximately 10 per 1000000 population12 In addition BP occurs more frequently in the elderly Routine histopathology reveals a sub-epidermal blister most often with large numbers of eosinophils Direct immunofluorescence of the skin of patients with BP reveals a linear band of C3 and IgG at the basement membrane zone Examination of the sera of patients shows the presence of a circulating anti-basement membrane zone autoantibody This antibody has been found to be directed against a 180 kd protein of the basement membrane zone type XVII collagen BPAg2 and against a 230 kd protein BPAg1 found in the epidermal hemi-desmosome34
BP is a severe disease most often requiring therapy with high dose systemic corticosteroids 075 - 10 mgkgday often for months5 In addition relapses are common and the additional use of immunosuppressive drugs such as azathioprine methotrexate cyclosporine A and others are needed to minimize the dose of systemic corticosteroids The 1-year mortality of BP has been estimated to range from 10 - 3016 Currently treatment of patients with BP consists of initial use of systemic corticosteroids 075 - 10 mgkgday Control of symptoms and new blister formation is most often achieved within 1 month and systemic corticosteroids are then tapered As many as 33 - 50 of patients may not be able to be tapered to clinically acceptable levels of systemic corticosteroids requiring the addition of systemic immunosuppression often with azathioprine Approximately 66 of patients require long term treatment with immunosuppressive medication to maintain control of their blistering578 The need for long term systemic corticosteroid therapy often with systemic immunosuppression in an elderly population results in a significant morbidity and mortality in patients with BP New therapeutic interventions that would potentially allow for the more rapid discontinuation of prednisone avoidance of systemic immuno- suppression and perhaps earlier clinical relapse would be of substantial benefit to patients with BP The clinical and laboratory data has demonstrated that BP is an autoantibody mediated blistering disease Taken together these observations suggest that the use of anti-CD20 antibody Rituxan may be useful in the treatment of patients with BP We have previously treated a patient with BP and graft versus host disease with anti-CD20 and anti-CD25 and were able to achieve clinical and serological remission within 4 weeks of initiation of therapy9 In addition others and we have successfully utilized Rituxan for the treatment of pemphigus vulgaris another autoantibody mediated autoimmune blistering disease10-15
BP is a severe disease most often requiring therapy with high dose systemic corticosteroids 075 - 10 mgkgday often for months5 In addition relapses are common and the additional use of immunosuppressive drugs such as azathioprine methotrexate cyclosporine A and others are needed to minimize the dose of systemic corticosteroids The 1-year mortality of BP has been estimated to range from 10 - 3016 Currently treatment of patients with BP consists of initial use of systemic corticosteroids 075 - 10 mgkgday Control of symptoms and new blister formation is most often achieved within 1 month and systemic corticosteroids are then tapered As many as 33 - 50 of patients may not be able to be tapered to clinically acceptable levels of systemic corticosteroids requiring the addition of systemic immunosuppression often with azathioprine Approximately 66 of patients require long term treatment with immunosuppressive medication to maintain control of their blistering578 The need for long term systemic corticosteroid therapy often with systemic immunosuppression in an elderly population results in a significant morbidity and mortality in patients with BP New therapeutic interventions that would potentially allow for the more rapid discontinuation of prednisone avoidance of systemic immuno- suppression and perhaps earlier clinical relapse would be of substantial benefit to patients with BP The clinical and laboratory data has demonstrated that BP is an autoantibody mediated blistering disease Taken together these observations suggest that the use of anti-CD20 antibody Rituxan may be useful in the treatment of patients with BP We have previously treated a patient with BP and graft versus host disease with anti-CD20 and anti-CD25 and were able to achieve clinical and serological remission within 4 weeks of initiation of therapy9 In addition others and we have successfully utilized Rituxan for the treatment of pemphigus vulgaris another autoantibody mediated autoimmune blistering disease10-15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None