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: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: Enbrel 25mg PFS
Product Name: Enbrel (Etanercept)
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
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=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. • To evaluate other clinical efficacy endpoints. • 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. | — |
Countries
France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed