Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396812
Status:
TERMINATED
Last Update Posted:
2013-02-12
First Post:
2006-11-06
Brief Title:
Rituximab for the Treatment of Early Rheumatoid Arthritis RA
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 Single Arm Single Center Phase III Trial of Rituximab a Monoclonal Antibody to CD20 for the Treatment of Early Rheumatoid Arthritis
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The perceived risk-benefit ratio for individuals with early active RA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rheumatoid arthritis RA is a chronic inflammatory disease characterized by joint swelling pain stiffness damage and ultimately loss of joint function Scientists estimate that about 13 million people 06 percent of the US adult population have RA Current therapies target the immune system early in the disease process before joint damage occurs and include drugs such as methotrexate MTX and tumor necrosis factor TNF-blocking agents Rituximab is a disease-modifying antirheumatic drug DMARD recently approved by the FDA for use in combination with MTX for treatment of moderately to severely active RA in patients who have had an inadequate response to TNF-blocking agents in an effort to try to slow the course of the disease This study will examine the effects of rituximab on the immune response and disease activity in participants with early RA who have not been treated with any disease-modifying agent In addition the safety and tolerability of rituximab in this population will be examined
Detailed Description:
RA is an inflammatory disease that causes pain swelling stiffness and loss of function in the joints It occurs when the immune system which normally defends the body from invading organisms turns its attack against the membrane lining the joints RA is commonly managed by DMARDs initiated early in the disease process before irreversible joint damage occurs The most common DMARD prescribed in the United States is MTX this drug is well tolerated and has better efficacy compared to other DMARDs but is inadequate in providing lasting improvement in individuals with RA In patients with an inadequate response to MTX alone the use of biologic agents including TNF-blocking agents in combination with MTX has become a standard therapeutic approach
Rituximab anti-CD20 is a man-made antibody used to treat certain types of cancer The drug blocks the CD20 antigen found on the surface of B cells and is known to deplete B cells when administered intravenously Previous research suggests B-cell activity is important in pathogenesis of RA so B-cell depletion may decrease inflammation and other symptoms of RA Rituximab has recently been approved by the FDA for use in combination with MTX for treatment of patients with moderately to severely active RA who have had an inadequate response to TNF-blocking agents This study will examine the effects of rituximab on the immune response and disease activity in patients with early active RA who have not been treated with any disease-modifying agent Levels of B and T cells and other markers of disease activity will be monitored during the study The safety and tolerability of rituximab in this DMARD-naive population will be examined
The expected duration of this study is 25 years All participants will receive two intravenous infusions of rituximab in an outpatient setting at study entry and Week 2 Throughout the study participants will receive MTX systemic corticosteroids and folic or folinic acid MTX dosing will be re-evaluated by disease activity scores every month until Month 6 and again at Months 8 10 and 12 Systemic corticosteroid doses will be modified based on the participants health while in the study Use of nonsteroidal anti-inflammatory drugs NSAIDs is permitted but NSAID doses should not be changed during the study if at all possible NSAIDs will not be provided by this study
There will be a maximum of 2 screening visits before study treatment a baseline visit Day 0 and 11 study visits A physical exam assessment for adverse events and blood collection will occur at all study visits Kidney and liver function tests and rheumatologic evaluations will occur at most study visits participants will also be asked to complete a questionnaire on their health at most study visits Arthroscopy knee biopsy on the more inflamed knee will occur at baseline and Month 3 Participants will be contacted by telephone the day after each arthroscopy and rituximab infusion
Rituximab anti-CD20 is a man-made antibody used to treat certain types of cancer The drug blocks the CD20 antigen found on the surface of B cells and is known to deplete B cells when administered intravenously Previous research suggests B-cell activity is important in pathogenesis of RA so B-cell depletion may decrease inflammation and other symptoms of RA Rituximab has recently been approved by the FDA for use in combination with MTX for treatment of patients with moderately to severely active RA who have had an inadequate response to TNF-blocking agents This study will examine the effects of rituximab on the immune response and disease activity in patients with early active RA who have not been treated with any disease-modifying agent Levels of B and T cells and other markers of disease activity will be monitored during the study The safety and tolerability of rituximab in this DMARD-naive population will be examined
The expected duration of this study is 25 years All participants will receive two intravenous infusions of rituximab in an outpatient setting at study entry and Week 2 Throughout the study participants will receive MTX systemic corticosteroids and folic or folinic acid MTX dosing will be re-evaluated by disease activity scores every month until Month 6 and again at Months 8 10 and 12 Systemic corticosteroid doses will be modified based on the participants health while in the study Use of nonsteroidal anti-inflammatory drugs NSAIDs is permitted but NSAID doses should not be changed during the study if at all possible NSAIDs will not be provided by this study
There will be a maximum of 2 screening visits before study treatment a baseline visit Day 0 and 11 study visits A physical exam assessment for adverse events and blood collection will occur at all study visits Kidney and liver function tests and rheumatologic evaluations will occur at most study visits participants will also be asked to complete a questionnaire on their health at most study visits Arthroscopy knee biopsy on the more inflamed knee will occur at baseline and Month 3 Participants will be contacted by telephone the day after each arthroscopy and rituximab infusion
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