(English) Cost-effectiveness of new medicines (Mabthera and Orencia) compared to a second TNF blocking medicine, for patients with inadequate effect of a first TNF blocking medicine. (Dutch)Onderzoek naar de kosteneffectiviteit van nieuwe medicijnen (Mabthera en Orencia) vergeleken met een tweede TNF blokerend middel, voor patienten met onvoldoende effect van een eerste behandeling met TNF blokkerende middelen.
Recruiting
- Conditions
- Rheumatoid Arthritis, Reumatoïde Artritis, cost-effectiveness, kosteneffectiviteit, doelmatigheid, daily clinical practice, dagelijkse klinische praktijk, biologicals, biologics, Targeted Immune Modulators, Rituximab, Abatacept, Adalimumab, Etanercept, Infliximab.
- Registration Number
- NL-OMON26753
- Lead Sponsor
- Department of Rheumatology, University Medical Centre Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 132
Inclusion Criteria
1. RA diagnosis according to ACR criteria;
2. Having been treated adequately with one of the anti-TNF alpha agents with insufficient effects;
Exclusion Criteria
1. Former treatment with abatacept or rituximab;
2. Patient's or physician's preference for one of the agents;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary clinical outcome is the mean of the DAS28 score measured at 6, 9 and 12 months follow-up. Furthermore costs (measured from a societal perspective), and quality adjusted life years (measured using utilities generated by the Euroqol 5D), over the first 12 months are additional primary outcomes.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are the health assessment questionnaire, the short-form 36, time to failure and the percentage of patients crossing over to another treatment.