The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study.
- Conditions
- Rheumatoid Arthritis.
- Registration Number
- EUCTR2005-000129-47-SE
- Lead Sponsor
- Dept. of Rhematology UMAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Patients with rheumatoid arthritis wich are planned to be treated with adalimumab (Humira) because of severe disease activity.Previously nonresponder on one DMARD. At the time of inclusion at least 6 swollen joints in 28-joint index protocoll and CRP more than 8 mg/L.
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
Anti-TNF treatment for the last three months.
Highdose peroral cortison (>= 20 mg daily) or has been treated with intravenous cortison two weeks before inclusion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does anti-inflammatory treatment with adalimumab (Humira) reduce endothelial activation in active rheumatoid arthritis (RA)?<br>Immunohistochemical markers of endothelial activation in skeletal muscles and common carotid artery intima-media thickness will be evaluated.<br>;Secondary Objective: ;Primary end point(s): Decrease of endotelial expression of HLA-DQ and IL1-alpha in muscle biopsies and common carotid artery intima-media thickness after three months of treatment.
- Secondary Outcome Measures
Name Time Method