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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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24 January 2022 |
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Main ID: |
EUCTR2008-002623-85-SE |
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Date of registration:
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04/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE
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Scientific title:
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A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE |
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Date of first enrolment:
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28/04/2010 |
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Target sample size:
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300 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002623-85 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Open-label for 52weeks phase 1, Double blind phase 2 and Double blind & Observational phase 3
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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France
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Germany
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Ireland
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Italy
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Netherlands
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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Product Name: 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
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
Product Code: L01BA01
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
CAS Number: 59052
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Methotrexate Sodium Tablets 2.5mg
Product Name: Methotrexate 2.5mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
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Primary Outcome(s)
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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
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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.
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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.
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Secondary ID(s)
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0881X1-4524-WW
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2008-002623-85-NL
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 03/03/2010
Contact:
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