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.

Pfizer33 sites in 5 countries429 target enrollmentJune 2009

ConditionsRheumatoid Arthritis

DrugsPhase 1: Methotrexate Phase 2: Optional ETN, SSZ, HCQ, MTX Phase 1: Conventiaonal DMARD

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Pfizer
Enrollment: 429
Locations: 33
Primary Endpoint: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

April 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24

Time Frame: 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).

Secondary Outcomes

Change From Baseline in HAQ Score at Week 24(Baseline and Week 24)
Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20(Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20)
Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24(Baseline and Week 24)
Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24(Baseline and Week 24)
Summary of Changes in Therapy at the Beginning of Phase 2(Week 24)
Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24(Week 24)
Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24(Week 24)
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24(Week 24)
Change From Baseline in Erosion Score Using vdH mTSS at Week 24(Week 24)
Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128(Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128)
Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128(Week 50, Week 76, Week 102, and Week 128)
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128(Week 50, Week 76, Week 102, and Week 128)
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128(Week 50, Week 76, Week 102, and Week 128)
Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)
Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24(Week 8, Week 16, and Week 24)