Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216762
Status:
TERMINATED
Last Update Posted:
2015-09-02
First Post:
2005-09-16
Brief Title:
Safety Study of Rituximab Rituxan in Chronic Urticaria
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Phase III Open Label Evaluation of the Safety and Efficacy of Rituximab in Patients With Chronic Urticaria The Rituximab Urticaria Study - RUSTY
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Full Clinical Hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to find out if a drug called Rituxan Rituximab is safe and effective in treating people with chronic urticaria hives with persistent symptoms in spite of taking antihistamines
Detailed Description:
Rituximab Rituxan is a recombinant chimeric monoclonal antibody that binds to a molecule CD20 that is present on the surface of B lymphocytes The product is approved for the treatment of non-Hodgkins lymphoma and has been investigated for the treatment of a number of autoimmune diseases including rheumatoid arthritis Edwards 2004 and lupus Looney 2004 Leandro 2002 As in most rheumatoid arthritis studies the medication will be administered in this study as a series of two intravenous infusions given 2 weeks apart
Many cases of chronic urticaria hives are though to be driven by an autoimmune mechanism Kaplan 2002 Grattan 2002 It is our hypothesis that by interfering with the autoimmune process potentially by decreasing the levels of autoantibodies or by interfering with other mechanisms that cause basophil and mast cell activation improvments in signs and symptoms will be seen
Given the effectiveness demonstrated for Rituximab in other autoimmune conditions we will conduct a pilot open label investigation of 15 patients with chronic urticaria to determine the safety and effectiveness of Rituximab in this disease All patients will receive the medication there will be no placebo group in this study Rituximab is not currently indicated for the treatment of this condition however
We will evaluate the safety of the Rituximab in 15 patients with urticaria as well as studies of antibody levels and cellular function We will also evaluate clinical outcomes such as itch score sleep disturbance and quality of life After receivng the Rituximab treatment we will begin to taper antihistamines and other medications used to control urticaria symptoms
Many cases of chronic urticaria hives are though to be driven by an autoimmune mechanism Kaplan 2002 Grattan 2002 It is our hypothesis that by interfering with the autoimmune process potentially by decreasing the levels of autoantibodies or by interfering with other mechanisms that cause basophil and mast cell activation improvments in signs and symptoms will be seen
Given the effectiveness demonstrated for Rituximab in other autoimmune conditions we will conduct a pilot open label investigation of 15 patients with chronic urticaria to determine the safety and effectiveness of Rituximab in this disease All patients will receive the medication there will be no placebo group in this study Rituximab is not currently indicated for the treatment of this condition however
We will evaluate the safety of the Rituximab in 15 patients with urticaria as well as studies of antibody levels and cellular function We will also evaluate clinical outcomes such as itch score sleep disturbance and quality of life After receivng the Rituximab treatment we will begin to taper antihistamines and other medications used to control urticaria symptoms
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