ong term prospective follow-up study of tocilizumab (RoActermraR) administered to patients with rheumatoid arthritis in daily clinical practice.
Phase 4
Completed
- Conditions
- inflammatory disease1000381610023213
- Registration Number
- NL-OMON34333
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
rheumatoid arthritis and treatment with tocilizumab
Exclusion Criteria
contraindications for treatment with tocilizumab
No signed informed consent
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy will be determined in comparison to baseline by comparing disease<br /><br>activity, radiological progression and functional capacity during follow-up.<br /><br>Safety will be determined by the occurrence of (serious) side effects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>There will be a particular focus of the effect of tocilizumab on lipid profile,<br /><br>bone density changes as well as risk factors for cardiovascular disease and<br /><br>osteoporosis.<br /><br>prognostic determinators will be assessed.</p><br>