Status:
TERMINATED
Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Integrated Therapeutics Group
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 inf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00394589
Start Date
March 1 2006
End Date
October 1 2008
Last Update
April 11 2017
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