The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)
- Conditions
- Rheumatoid arthritisMedDRA version: 12.0Level: PTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2008-005450-20-BE
- Lead Sponsor
- Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 261
Inclusion Criteria
- Having been treated adequately with a primary ant TNF alpha agent and having failed due to ineffectiveness or the occurence of adverse events
- Having moderate to high level of disease activity (DAS28>3.2)
- No former treatment with abatacept or rituximab
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
- Contraindication for one of the study drugs
- Having a strong preferance for one of the study druges
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1 year non-inferiority trial of abatacept vs rituximab vs a second anti-tnf alpha agent withe regards to mean DAS28 value measured at 6, 9 an 12 months;Secondary Objective: Cost-effectiveness analysis, drugsurvival, registration of daily practise use.;Primary end point(s): The primary endpoints will be the, for baseline DAS28 corrected, mean DAS28 score (clinical) measured at 6, 9 and 12 months, the EQ-5D score (overall 'quality of life' value) at 12 months and the direct and indirect costs from a societal perspective over a period of 12 months.
- Secondary Outcome Measures
Name Time Method