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A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.
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 with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 429 |
| Start date | 2009-06 |
| Completion | 2013-04 |
Conditions
- Rheumatoid Arthritis
Interventions
- Phase 1: Etanercept
- Phase 1: Methotrexate
- Phase 2: Optional ETN, SSZ, HCQ, MTX
- Phase 1: Methotrexate
- Phase 1: Conventiaonal DMARD
Primary outcomes
- Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 — Week 24
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).
Countries
Argentina, Chile, Colombia, Mexico, Panama