Status:
COMPLETED
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Amgen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
Brief Summary
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects wit...
Eligibility Criteria
Inclusion
- Diagnosis of Rheumatoid Arthritis (RA)
- Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
- Active Rheumatoid Arthritis (RA) at time of screening and baseline
Exclusion
- Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
- Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
- Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT00848354
Start Date
June 1 2009
End Date
April 1 2013
Last Update
January 18 2016
Active Locations (33)
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1
Investigaciones Reumatológicas y Osteológicas
Buenos Aires, Argentina, Argentina, C1114AAH
2
OMI
Buenos Aires, Buenos Aires, Argentina, 1015
3
Centro de Investigaciones en Enfermedades Reumaticas
Buenos Aires, Buenos Aires, Argentina, 1055
4
Hospital Britanico
Buenos Aires, Buenos Aires, Argentina, 1280