Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

Wyeth

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept , Methotrexate; Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422227

0881A1-408

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.

Enrollment: 300 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA
• Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
• Active RA at time of screening and baseline

Exclusion criteria

• Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
• Concurrent treatment with a DMARD, other than MTX, at screening
• Receipt of any DMARD, other than MTX, within 3 months before screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Active Comparator group

Description:

Etanercept + Methotrexate

Treatment:

Drug: Etanercept , Methotrexate

2

Active Comparator group

Description:

DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide

Treatment:

Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide