Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3) (Re³)
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 mg/kg 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 0.6 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)
|Rheumatoid Arthritis||Drug: Infliximab Increased Frequency Drug: Infliximab Increased Dose Drug: Infliximab Control||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.|
- Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score. [ Time Frame: Between Screening (Week <=1) and Week 24 ]Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).
|Study Start Date:||March 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
Drug: Infliximab Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks
Other Name: Increased Frequency
Experimental: Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks
Drug: Infliximab Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks
Other Name: Increased Dose
Active Comparator: Control
Continuation of infliximab 3 mg/kg every 8 weeks
Drug: Infliximab Control
Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks
Other Name: Control