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

Phase 4CompletedNCT00195494

Wyeth is now a wholly owned subsidiary of Pfizer542 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

542

Conditions

Rheumatoid Arthritis

Interventions

EtanerceptDRUG

Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 \& 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2

MethotrexateDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Denver, Colorado, United States

Outcomes

Primary Outcomes

The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.

Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.

Time frame: 12 months

Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.

The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.

Time frame: 12 months

Secondary Outcomes

Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death

Safety report for entire trial where participants reported a serious adverse event that led to death.

Time frame: 12 and 24 months

Data from ClinicalTrials.gov

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