Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094380
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2004-10-16
Brief Title:
Treating Systemic Lupus Erythematosus SLE Patients With CTLA4-IgG4m RG2077
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide A Phase IIIA Study
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this study is to examine the safety of a single dose of RG2077 in patients with systemic lupus erythematosus SLE who are currently receiving cyclophosphamide This study will also determine if RG2077 is effective in decreasing disease activity in these patients
Study hypothesis CTLA4-Ig mediates a T cell costimulatory blockade that effectively induces an antigen-specific nonresponsiveness in T cells
Study hypothesis CTLA4-Ig mediates a T cell costimulatory blockade that effectively induces an antigen-specific nonresponsiveness in T cells
Detailed Description:
SLE is a chronic inflammatory autoimmune disorder that may affect many organ systems including the skin joints and internal organs RG2077 has been studied for use in multiple sclerosis another autoimmune disorder This study will evaluate the safety and efficacy of RG2077 in SLE patients who are currently receiving cyclophosphamide
This trial is composed of two parts The first part is a dose-escalation study in which participants will receive one of two doses of RG2077 02 mgkg or 2 mgkg this part of the study will last 60 days At screening patients will have an IV catheter inserted into their arms for administration of cyclophosphamide and RG2077 Patients will also have medical and medication history assessments a comprehensive physical exam and blood and urine tests There are 5 study visits for the first part of the trial these will occur at screening at study entry and Days 1 14 and 28 Selected visits will include physical exam vital signs measurement blood and urine tests and disease activity assessment At Days 7 and 60 patients will be contacted by phone to report their medication history and any adverse effects they have experienced
The second part of the study will evaluate a single 10 mgkg dose of RG2077 this part of the study will last 90 days In the study participants will be randomly assigned to one of two groups At the start of the study Group 1 participants will receive RG2077 and cyclophosphamide and Group 2 participants will receive cyclophosphamide only There will be 9 study visits these will occur at study screening study entry and Days 1 4 7 14 28 and 60 At selected visits patients will undergo physical exam vital signs measurement blood tests and urine tests and disease activity assessment
This trial is composed of two parts The first part is a dose-escalation study in which participants will receive one of two doses of RG2077 02 mgkg or 2 mgkg this part of the study will last 60 days At screening patients will have an IV catheter inserted into their arms for administration of cyclophosphamide and RG2077 Patients will also have medical and medication history assessments a comprehensive physical exam and blood and urine tests There are 5 study visits for the first part of the trial these will occur at screening at study entry and Days 1 14 and 28 Selected visits will include physical exam vital signs measurement blood and urine tests and disease activity assessment At Days 7 and 60 patients will be contacted by phone to report their medication history and any adverse effects they have experienced
The second part of the study will evaluate a single 10 mgkg dose of RG2077 this part of the study will last 90 days In the study participants will be randomly assigned to one of two groups At the start of the study Group 1 participants will receive RG2077 and cyclophosphamide and Group 2 participants will receive cyclophosphamide only There will be 9 study visits these will occur at study screening study entry and Days 1 4 7 14 28 and 60 At selected visits patients will undergo physical exam vital signs measurement blood tests and urine tests and disease activity assessment
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