Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036491
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2002-05-10
Brief Title:
Anti-CD20 in Systemic Lupus Erythematosus
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody Rituximab Rituxan for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2017-11
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 determine the safety and effectiveness of rituximab anti-CD20 in treating systemic lupus erythematosus SLE
White blood cells in the body called B cells give off substances that are active in promoting SLE disease Researchers have found that anti-CD20 can block production of these substances in another disease This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE
White blood cells in the body called B cells give off substances that are active in promoting SLE disease Researchers have found that anti-CD20 can block production of these substances in another disease This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE
Detailed Description:
B cells clearly play an essential role in the pathogenesis of SLE since they produce autoantibodies Clinical observations support the contention that intervening in the production of autoantibodies by the B lymphocyte will be effective therapy Current approved therapy for B-cell non-Hodgkins lymphoma includes anti-CD20 The results of anti-CD20 administration in SLE are anticipated to be similar to those in lymphoma patients The current proposal explores the mechanisms and applicability of B-cell depletion as a potential treatment for SLE
Participants receive 4 weekly infusions of study medication Each participant is enrolled in the study for a total of 1 year with protocol visits weekly for the first 3 months then every other week for the next 2 months every month for the next 4 months and every other month for the remaining 5 months of the study Weeks 0 1 2 3 4 5 6 7 9 11 13 15 19 23 27 31 39 47 and 55 Responses to exogenous antigens are measured assessments for clinical response with SLE-disease activity score SLEDEI and systemic lupus activity measure SLAM score are performed Participants complete a health questionnaire and a health survey and laboratory parameters are evaluated
Participants receive 4 weekly infusions of study medication Each participant is enrolled in the study for a total of 1 year with protocol visits weekly for the first 3 months then every other week for the next 2 months every month for the next 4 months and every other month for the remaining 5 months of the study Weeks 0 1 2 3 4 5 6 7 9 11 13 15 19 23 27 31 39 47 and 55 Responses to exogenous antigens are measured assessments for clinical response with SLE-disease activity score SLEDEI and systemic lupus activity measure SLAM score are performed Participants complete a health questionnaire and a health survey and laboratory parameters are evaluated
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACE Study AC002 | OTHER | Autoimmunity Centers of Excellence | None |
| SACCC ASL02 | OTHER | None | None |
| UPenn U1131s | OTHER | None | None |