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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 16 December 2017
Main ID:  NCT00394589
Date of registration: 31/10/2006
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3) Re³
Scientific title: Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.
Date of first enrolment: March 2006
Target sample size: 43
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Austria Belgium Denmark France Germany Netherlands Sweden Turkey
Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Infliximab Control
Drug: Infliximab Increased Dose
Drug: Infliximab Increased Frequency
Primary Outcome(s)
Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score. [Time Frame: Between Screening (Week <=1) and Week 24]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Integrated Therapeutics Group
Ethics review
Results available: Yes
Date Posted: 21/01/2010
Date Completed:
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