Tocilizumab met biopten cohort.Tocilizumab with biopsy cohort.
Recruiting
- Conditions
- RA, reuma, rheumatiod arthritis
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Males/females suffering from RA, classified according to the 2010 ACR/EULAR classification criteria for RA, who have active disease (DAS28 „d3.2) despite adequate methorexate treatment, will be eligible for the study. Patients in ARA functional classes I, II, and III may be included.
In addition, patients must fulfill the following criteria at baseline:
Exclusion Criteria
1. Pregnancy;
2. Breastfeeding;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of tocilizumab in patients with active RA.
- Secondary Outcome Measures
Name Time Method The secondary objectives of this study are to:<br /><br>1. Assess clinical response at week 16;<br /><br>2. Identify synovial biomarkers predictive of the clinical response to tocilizumab treatment.