Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis (PRESERVE)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Etanercept; Drug: Methotrexate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565409

0881A1-4423

B1801003

Details and patient eligibility

About

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

Enrollment: 834 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of rheumatoid arthritis.
• Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
• Active rheumatoid arthritis at the time of screening.

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), other than MTX within 28 days before baseline.
• Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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834 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Etanercept

Drug: Methotrexate

Drug: Methotrexate

Drug: Etanercept

Drug: Methotrexate

2

Active Comparator group

Treatment:

Drug: Etanercept

Drug: Methotrexate

Drug: Methotrexate

Drug: Etanercept

Drug: Methotrexate

3

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Methotrexate

Drug: Methotrexate

Drug: Methotrexate