Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051623
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2003-01-14
Brief Title:
A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Trial of Anti-TNFa Chimeric Monoclonal Antibody Infliximab for the Treatment of Patients With Psoriatic Arthritis
Status:
COMPLETED
Status Verified Date:
2010-03
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 determine if Infliximab is safe and effective in the treatment of psoriatic arthritis Infliximab Remicade targets specific proteins in the bodys immune system to help control the development of inflammation to help reduce painful disease
Detailed Description:
This is a phase III multicenter 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 placebo-controlled study designed to determine the safety and effectiveness of Infliximab in the treatment of patients with psoriatic arthritis This is an experimental medical research study A total of 200 people in North America and Europe participated in this study during the 17 month study period Patients will receive infusions of either placebo or 5 or 10 mgkg infliximab Remicade at weeks 02 6 14 16 18 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 either placebo or 5 mgkg induction infusions weeks 0 2 and 6 followed by maintenance infusions every 8 weeks until week 46 In the placebo group patients may early escape at week 16 and crossover at week 24 to infliximab In the 5mgkg group dose escalation if needed at week 38
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