Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, cardiovascular disease, adalimumab
Brief summary
The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.
Interventions
DRUGAdalimumab
40 mg IV every 14 days
Sponsors
Abbott
The Swedish Research Council
The Swedish Rheumatism Ass
Crafoord Foundation
Skane University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of rheumatoid arthritis * Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis * Active disease despite treatment with at least one disease modifying anti-rheumatic drug * Treatment with adalimumab indicated according to the the patient's rheumatologist * At least six swollen joints in 28-joint index * CRP \> 8 mg / L within the last three months
Exclusion criteria
* Treatment with anti-TNF drugs in the last three months * Treatment with intravenous corticosteroids within fourteen days * Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion * Severe bleeding disorder * Extensive or refractory leg ulcers * Severe peripheral vascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial expression of HLA-DQ in muscle biopsies | 3 months | Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis |
| Endothelial expression of interleukin-1 alpha in muscle biopsies | 3 months | Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis |
| Carotid artery intima-media thickness | 3 months | Thickness of the intima and media of the common carotid artery, measured by ultrasound. Mean of two measures of the right and left common carotid artery. |
Countries
Sweden
Outcome results
None listed