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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00394589
• Date of registration: 31/10/2006
• Prospective Registration: No
• 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
• URL: https://clinicaltrials.gov/show/NCT00394589
• 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

Intervention(s)

Drug: Infliximab Increased Dose

Drug: Infliximab Increased Frequency

Drug: Infliximab Control

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 ID(s)

P04249

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Integrated Therapeutics Group

Results

• Results available: Yes
• Date Posted: 21/01/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00394589