Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036387
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2002-05-09
Brief Title:
A Study of the Safety and Effectiveness of Infliximab Remicade in Patients With Rheumatoid Arthritis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Randomized Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody Infliximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of Infliximab Remicade in patients with Rheumatoid Arthritis Infliximab Remicade targets specific proteins in the bodys immune system to help control the development of inflammation to help reduce the pain of rheumatoid arthritis
Detailed Description:
This is a randomized patients are assigned different treatments based on chance double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage trial of the safety of anti-tumor necrosis factor TNF chimeric monoclonal antibody Infliximab in combination with methotrexate MTX compared to methotrexate alone in patients with rheumatoid arthritis on standard disease-modifying anti-rheumatic drug background therapy The purpose of the study is to better understand the safety and occurrence of infections in patients treated with either placebo or 3 mgkg and 10 mgkg of infliximab in combination with methotrexate MTX
Patients will receive infusions of either placebo or 3 to 10mgkg Infliximab at weeks 0 2 6 and 14 then every 8 weeks through week 46
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures Patients will receive 3 to10mgkg Infliximab Remicade or placebo via infusion at weeks 0 2 6 and 14 then every 8 weeks through week 46
Patients will receive infusions of either placebo or 3 to 10mgkg Infliximab at weeks 0 2 6 and 14 then every 8 weeks through week 46
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures Patients will receive 3 to10mgkg Infliximab Remicade or placebo via infusion at weeks 0 2 6 and 14 then every 8 weeks through week 46
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