A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato.

Phase 1

• 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).Artritis reumatoide; MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-19
• Study Completion: 2012-12-17
• Last Update Posted: 8 October 2021

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
F.1.3 Elderly (>=65 years) yes
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;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.