A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

• Register: EUCTR
• Last refreshed on: 11 February 2013
• Main ID: EUCTR2008-002623-85-NL
• Date of registration: 01/05/2009
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
• Public title: A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE
• Scientific title: A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE
• Date of first enrolment: 27/07/2009
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002623-85
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Open during phase 1, Double blind during phase 2 and Double blind and Observational during phase 3 If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom

Key inclusion & exclusion 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<=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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use

Trade Name: Enbrel 50mg PFS
Product Name: Enbrel (Etanercept)
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use

Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate 2.5mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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 ID(s)

0881X1-4524