Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

• Conditions: Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2008-002623-85-DE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-12
• Last Update Posted: 28 January 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.
• MTX-naïve
• In paid employment (either full-time or part-time), or in unpaid but measurable work such as caring for a family and home. (NOTE: enrolment is expected for a majority of subjects who are in paid employment on entry into the study).
• DAS28 >3.2

Phase 2:
• Responder status at the end of phase 1 participation: subject with DAS28<=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 low disease activity (2.6<= DAS28<=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 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Phase 1:
• Prior treatment with MTX
• Received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist (e.g., a TNF monoclonal antibody or a soluble TNF receptor) or other biologic treatment for RA.
• Pregnant or breast feeding women
• Has any contra-indications listed in the European SmPC for ETN.
• Use of investigational drug or device within 3 months prior to the first dose of test article administration.

Phase 2:
• Non-Responder status at the end of phase 1 participation

Phase 3:
• Non-Responder status at the end of phase 2 participation

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: For the Phase 1 responders, to assess the efficacy of ETN 25 mg once weekly (in combination with MTX) for the maintenance of sustained remission for a further 39-week period, in comparison with continued placebo. ;Secondary Objective: • Assess productivity as measured using the Work Productivity and Activity Impairment Questionnaire: RA (WPAI:RA). WPAI:RA will be measured approximately every 13 weeks and the total productivity impact for each subject across all visits will be evaluated.<br>• To evaluate other clinical efficacy endpoints.<br>• To assess the safety of the treatment regimens over the 3 study phases<br>;Primary end point(s): The proportion of subjects with sustained remission defined as DAS28 <2.6 at the week 76 and 91 visits of Phase 2 and no corticosteroid boost between weeks 52 and 64 Visits.;Timepoint(s) of evaluation of this end point: Weeks 52, 56, 64, 76 & 91

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Over the last 3 months of phase 1 and phase 2, a composite measure of complete<br>response, defined as:<br>- DAS28 <2.6 at the week 39 and week 52 visits (phase 1) or the week 76 and 91 visits<br>(phase 2), AND<br>- No radiographic progression over the end of the phase time point (defined as mean<br>change in modified total Sharp score (mTSS) =0.5; blinded assessor), AND<br>- Health Assessment Questionnaire (HAQ) = 0.5 at the week 39 and week 52 visits<br>(phase 1) or week 76 and week 91 visits (phase 2).<br>• Evaluation of clinical scores or changes from baseline of clinical scores (eg, mTSS,<br>Disease Activity Score based on a 44-joint count [DAS44]).<br>;Timepoint(s) of evaluation of this end point: The timepoints are contained within the endpoints