Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036374
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2002-05-09
Brief Title:
A Study of the Safety and Effectiveness of Infliximab Remicade in Patients With Juvenile Rheumatoid Arthritis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Randomized Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody Infliximab in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2010-04
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 effectiveness and safety of infliximab Remicade in patients with Juvenile Rheumatoid Arthritis JRA
Detailed Description:
The purpose of this study is to determine if infliximab in combination with methotrexate is safe and effective in the treatment of patients with juvenile rheumatoid arthritis The second purpose of this study is to see how childrens bodies react to the combination of study drug and methotrexate Patients will receive either infliximab at 3 mgkg for 44 weeks or placebo for 14 weeks followed by infliximab at 6 mgkg for 30 weeks Patients who complete the original study are eligible for additional treatment with 3 to 6 mgkg of infliximab every 8 weeks for up to three years 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 either infliximab at 3 mgkg for 44 weeks or placebo for 14 weeks followed by infliximab at 6 mgkg for 30 weeks Patients who complete the original study are eligible for additional treatment with 3 to 6 mgkg of infliximab every 8 weeks for up to three years
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