A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZE

• Conditions: Moderate to severe early Rheumatoid Arthritis (RA).; MedDRA version: 12.0Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2008-002623-85-IT
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-30
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Phase 1:
Female or male 18 years of age or older.
Meets the 1987 American College of Rheumatology (ACR) Revised Criteria for Rheumatoid Arthritis.
Had symptom (swollen joints) onset 12 months or less from date of enrollment.
Is MTX- na?ve.
In paid employment, either full or part time OR in unpaid but measurable work, such as caring for a family and home. (NOTE: The study target is to enroll a majority of subjects who are in paid employment on entry into the study.)
Has a DAS28>3.2.

Phase 2:
Responder status at the end of phase 1 participation: subject with DAS28&#8804;3.2 at the week 39 visit and DAS28<2.6 at the week 52 visit.

Phase 3:
Responder status at the end of phase 2 participation: subject in remission (DAS28<2.6) or with low disease activity (2.6&#8804; DAS28&#8804;3.2) at the week 91 visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Phase 1:
Received prior treatment with MTX.
Received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist (eg, a TNF monoclonal antibody or a soluble TNF receptor) or other biologic treatment for RA.
Is a pregnant or breast feeding woman
Has any contraindications listed in the European Summary of Product Characteristics (SmPC) for ETN.
Used investigational drug or device within 3 months prior to the first dose of test article administration.

Phase 2:
Nonresponder status at the end of phase 1 participation.

Phase 3:
Nonresponder status at the end of phase 2 participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified