CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 429 enrolled
Drug / intervention
Phase 1: Etanercept +4 morebiological
Likely dose
Phase 1: Etanercept 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00848354
NCT00848354Phase 4Completed
CompareCT.gov

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.

Pfizer·interventional·Posted Feb 20, 2009·Updated Jan 18, 2016

In Brief

A Phase 4 clinical trial evaluating Phase 1: Etanercept, Phase 1: Methotrexate, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 429 participants across 33 sites in 5 countries.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Chile, Colombia, Mexico, Panama
CollaboratorsAmgen

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.4 years ago

Interventions

Phase 1: Etanerceptbiological

Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24

Phase 1: Methotrexatedrug

Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.

Phase 2: Optional ETN, SSZ, HCQ, MTXdrug

Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128. Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.

Phase 1: Methotrexatedrug

Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.

Phase 1: Conventiaonal DMARDdrug

Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.