Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394589
Status:
TERMINATED
Last Update Posted:
2017-04-11
First Post:
2006-10-31
Brief Title:
Re³ Re-Cube Retain Remicade ResponseStudy P04249AM3
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study enrollment was stopped due to insufficient subject accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Re³
Brief Summary:
This Phase IIIb randomized multi-national multi-center blinded study of Infliximab IFX in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity
Subjects responding to an initial infliximab treatment regimen who flare during continuation of treatment at 3 mgkg administered every 8 weeks will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded The increased frequency group is not blinded Clinical assessments of disease activity will be based the European League Against Rheumatism EULAR criteria for response Safety parameters will be assessed at every infusion
A disease flare is defined by an increase in DAS28 with 06 or more at screening when compared to the DAS28 score measured immediately prior to the last Remicade infusion and depends upon the actual score as well Since prior to enrollment the subject received Remicade as per routine clinical practice the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2 6 and 14
Drug Infliximab Control double-blinded
Drug Infliximab Increased Dose double-blinded
Drug Infliximab Increased Frequency open-label
Subjects responding to an initial infliximab treatment regimen who flare during continuation of treatment at 3 mgkg administered every 8 weeks will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded The increased frequency group is not blinded Clinical assessments of disease activity will be based the European League Against Rheumatism EULAR criteria for response Safety parameters will be assessed at every infusion
A disease flare is defined by an increase in DAS28 with 06 or more at screening when compared to the DAS28 score measured immediately prior to the last Remicade infusion and depends upon the actual score as well Since prior to enrollment the subject received Remicade as per routine clinical practice the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2 6 and 14
Drug Infliximab Control double-blinded
Drug Infliximab Increased Dose double-blinded
Drug Infliximab Increased Frequency open-label
Detailed Description:
None
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