Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483119
Status:
TERMINATED
Last Update Posted:
2016-02-18
First Post:
2007-06-05
Brief Title:
Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase 2 Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to the death of the PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare two standard treatments for pemphigus to determine which more effectively improves the clinical manifestations of the disease and decreases serum level of the autoantibodies which cause the disease
Detailed Description:
Pemphigus is a serious and life-threatening autoimmune disease characterized by blisters and erosions that occur on the skin and oral mucosa It is caused by autoantibodies that attack desmoglein 1 and 3 adhesion molecules that are present on the surface of the cells keratinocytes that make up the superficial layer of the skin As a result these cells stop sticking together and come apart resulting in the formation of blisters on the skin
Pemphigus is usually treated with systemic corticosteroids often given together with immunosuppressive drugs such as Cytoxan cyclophosphamide Imuran azathioprine methotrexate CellCept mycophenolate mofetil and others However the prolonged and high doses of systemic steroids and other immunosuppressive agents used to treat the disease are associated with significant toxicity
A new treatment which is now being used to treat pemphigus patients that are unresponsive or that have developed complications to conventional treatment is IVIg intravenous immunoglobulin IVIg consists of one of the protein fractions present in blood It is the fraction that contains antibodies and is called immunoglobulin Ig It is purified from blood that has been collected from thousands of donors and treated to remove potential infectious agents It is administered intravenously IV over several hours several days in succession The cycles are usually repeated every 2 to 4 weeks until the disease is controlled
IVIg treatment is currently given in either of two ways either by itself or with an immunosuppressive drug such as cyclophosphamide or azathioprine It is unknown which of these two procedures is better This trial is being conducted to determine which treatment is more effective
The trial is being conducted in patients with pemphigus that are not responding to or have developed complications from standard treatment All patients will be treated with IVIg administered using a standard protocol The IVIg will be given daily for 4 days and this cycle will be repeated every other week for a total of 4 cycles In addition half of the patients will be selected by chance to also be treated with cyclophosphamide an immunosuppressive drug often used to treat other autoimmune diseases including pemphigus The cyclophosphamide is a pill that is taken 3 times a day A total of 12 patients will be treated in each arm of the trial The trial is being conducted by Dr Jean-Claude Bystryn at the New York University Medical Center
The extent and activity of the disease as well as the blood levels of pemphigus antibodies will be measured at baseline prior to entry into the trial and periodically during the trial
The goal of the study is to determine whether there is a difference between the two treatments in the rate at which 1 the activity and extent of the disease improves 2 the dose of corticosteroids required to treat the disease can be reduced and 3 the blood level of pemphigus antibodies decrease
This trial will test this hypothesis by examining whether IVIg treatment given with cyclophosphamide results in a more rapid decline in circulating pemphigus antibodies than when given alone
Pemphigus is usually treated with systemic corticosteroids often given together with immunosuppressive drugs such as Cytoxan cyclophosphamide Imuran azathioprine methotrexate CellCept mycophenolate mofetil and others However the prolonged and high doses of systemic steroids and other immunosuppressive agents used to treat the disease are associated with significant toxicity
A new treatment which is now being used to treat pemphigus patients that are unresponsive or that have developed complications to conventional treatment is IVIg intravenous immunoglobulin IVIg consists of one of the protein fractions present in blood It is the fraction that contains antibodies and is called immunoglobulin Ig It is purified from blood that has been collected from thousands of donors and treated to remove potential infectious agents It is administered intravenously IV over several hours several days in succession The cycles are usually repeated every 2 to 4 weeks until the disease is controlled
IVIg treatment is currently given in either of two ways either by itself or with an immunosuppressive drug such as cyclophosphamide or azathioprine It is unknown which of these two procedures is better This trial is being conducted to determine which treatment is more effective
The trial is being conducted in patients with pemphigus that are not responding to or have developed complications from standard treatment All patients will be treated with IVIg administered using a standard protocol The IVIg will be given daily for 4 days and this cycle will be repeated every other week for a total of 4 cycles In addition half of the patients will be selected by chance to also be treated with cyclophosphamide an immunosuppressive drug often used to treat other autoimmune diseases including pemphigus The cyclophosphamide is a pill that is taken 3 times a day A total of 12 patients will be treated in each arm of the trial The trial is being conducted by Dr Jean-Claude Bystryn at the New York University Medical Center
The extent and activity of the disease as well as the blood levels of pemphigus antibodies will be measured at baseline prior to entry into the trial and periodically during the trial
The goal of the study is to determine whether there is a difference between the two treatments in the rate at which 1 the activity and extent of the disease improves 2 the dose of corticosteroids required to treat the disease can be reduced and 3 the blood level of pemphigus antibodies decrease
This trial will test this hypothesis by examining whether IVIg treatment given with cyclophosphamide results in a more rapid decline in circulating pemphigus antibodies than when given alone
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