Rheumatoid Arthritis.
Conditions
Interventions
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Dept. of Rhematology UMAS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does anti-inflammatory treatment with adalimumab (Humira) reduce endothelial activation in active rheumatoid arthritis (RA)? Immunohistochemical markers of endothelial activation in skeletal muscles and common carotid artery intima-media thickness will be evaluated. ;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. | — |
Countries
Sweden
Outcome results
None listed