Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073437
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2003-11-20
Brief Title:
A Study of Infliximab in Patients With Sarcoidosis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab Remicade in Subjects With Chronic Sarcoidosis With Pulmonary Involvement
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 safety and effectiveness of infliximab Remicade in patients with Chronic Sarcoidosis Infliximab Remicade targets specific proteins in the bodys immune system to help control the development of inflammation to help reduce painful disease
Detailed Description:
The purpose of this study is to evaluate the safety and effectiveness of infliximab in the treatment of subjects with sarcoidosis with pulmonary involvement who show symptoms of the disease even though they are currently being treated with medication Patients will receive either placebo 3 mgkg infliximab or 5 mgkg infliximab infusions at weeks 0 2 6 12 18 and 24 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 infusions of Infliximab Remicade 3 or 5 mgkg or placebo at weeks 0 2 6 12 18 and 24
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