Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Infliximab Increased Frequency; Infliximab Increased Dose; Infliximab Control
Intervention description: Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks; 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks; Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 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)
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 18 years or more

          -  with RA according to ACR criteria

          -  presented with a disease flare after initial response to infliximab, with both
             response and flare being defined using the DAS28 score (EULAR criteria)

          -  received the standard Remicade® dosing schedule per the EU label (3 mg/kg at Weeks 0,
             2, 6, [and 14])

          -  an initial response documented by moderate or good DAS28 improvement (EULAR criteria)
             from Week 0 to Week 6 or 14.

        Exclusion Criteria:

          -  a female who is, or intends to become, pregnant during or within 6 months of the end
             of the study, is nursing or not using adequate contraceptive measures

          -  has not observed the designated periods for concomitant medications

          -  used any investigational medical product within 30 days prior to Baseline

          -  any clinically significant deviation from normal in the physical examination or chest
             X-ray that in the investigator's judgment, may interfere with the study evaluation or
             affect subject safety

          -  rheumatic disease other than RA or has any systemic inflammatory condition with signs
             and symptoms that might confound the evaluations of safety and toxicity

          -  allergic reaction/sensitivity to the study drug or its excipients that requires
             corticosteroid pre-infusion medication.