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Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3) (Re³)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394589
Recruitment Status : Terminated (Study enrollment was stopped due to insufficient subject accrual.)
First Posted : November 1, 2006
Results First Posted : January 21, 2010
Last Update Posted : April 11, 2017
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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)

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Infliximab Increased Frequency Drug: Infliximab Increased Dose Drug: Infliximab Control Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
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.
Study Start Date : March 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00394589    
Other Study ID Numbers: P04249
First Posted: November 1, 2006    Key Record Dates
Results First Posted: January 21, 2010
Last Update Posted: April 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents