Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

Pfizer

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Biological: Phase 1: Etanercept; Drug: Phase 1: Methotrexate; Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX; Drug: Phase 1: Conventiaonal DMARD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848354

0881A1-4532

B1801004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 429 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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429 participants in 2 patient groups

Phase 1 Etanercept + methotrexate

Experimental group

Description:

Phase 1: Etanercept + methotrexate

Treatment:

Drug: Phase 1: Methotrexate

Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX

Drug: Phase 1: Methotrexate

Biological: Phase 1: Etanercept

Phase 1 Conventional DMARD (SSZ or HCQ) + MTX

Active Comparator group

Description:

Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate

Treatment:

Drug: Phase 1: Methotrexate

Drug: Phase 1: Methotrexate

Drug: Phase 1: Conventiaonal DMARD