Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 4

Conditions: Active Rheumatoid Arthritis; Arthritis, Rheumatoid; Rheumatoid Arthritis

Treatments: Drug: etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913458

B1801020

0881X1-4524

Details and patient eligibility

About

Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of early rheumatoid arthritis.
• Methotrexate (MTX) naive.
• Active early rheumatoid arthritis at the time of enrollment.

Exclusion criteria

• Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
• Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.
• Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 1 patient group

1

Experimental group

Description:

etanercept + methotrexate; etanercept + methotrexate

Treatment:

Drug: etanercept