Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076726
Status:
TERMINATED
Last Update Posted:
2011-05-17
First Post:
2004-02-02
Brief Title:
A Study of the Safety and Effectiveness of Infliximab Remicade in Patients With Giant Cell Arteritis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Randomized Double-Masked Placebo-Controlled Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis infliximab did not reduce number of first relapses in GCA or cumulative glucocorticosteroid dosage
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 efficacy effectiveness of Infliximab Remicade in patients with Giant Cell Arteritis 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 see if infliximab is safe and effective in treating GCA Currently the only treatment for GCA is prednisone GCA is a long lasting inflammatory disease The cause is unknown It may affect all the arteries but it focuses on the big vessels such as those around the heart the vessels in the neck and head and their major branches It can lead to vision loss blindness stroke stenosis narrowing of blood vessels and aneurysms a weakening in the lining of the blood vessel wall which may eventually lead to rupture of the blood vessel The damage to the arteries is caused by an immune response A naturally occurring substance in the immune system called tumor necrosis factor alpha TNFa plays a significant role in this immune response against the blood vessels This response is thought to cause the long-lasting inflammation irritation and swelling of the vessels By blocking the effect of TNFa we think that we may reduce the signs and symptoms associated with GCA This trial will study patients who are stable on prednisone treatment by evaluating whether infliximab can control their symptoms as the dose of prednisone is reduced Patients will receive infusions of either 5mgkg of infliximab or placebo at weeks 0 2 6 14 22 30 38 and 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 receive infusions of either 5mgkg infliximab or placebo infusions at weeks 0 2 6 14 22 30 38 and 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