Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

Wyeth

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195494

0881A-101548

Details and patient eligibility

About

To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.

Enrollment: 542 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
• Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion criteria

• Received any previous treatment with MTX
• Received any previous treatment with ETN or other tumour necrosis factor antagonist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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542 participants in 4 patient groups

1a

Active Comparator group

Description:

Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)

Treatment:

Drug: Etanercept

Drug: Methotrexate

1b

Active Comparator group

Description:

Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)

Treatment:

Drug: Placebo

Drug: Etanercept

Drug: Methotrexate

2a

Active Comparator group

Description:

Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)

Treatment:

Drug: Placebo

Drug: Etanercept

Drug: Methotrexate

2b

Active Comparator group

Description:

Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)

Treatment:

Drug: Methotrexate