Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare ultrasound examination with wholebody MRI etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Sc. inj. adalimumab 40 mg every other week for 42 to 48 weeks. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.
sc. inj. placebo every other week, week 0, 2, and 4. Sc. inj. adalimumab 40 mg every other week from week 6. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.
Dep. of medicine, Herlev Hospital
Copenhagen, Denmark
Dep. of Radiology, Herlev Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
Copenhagen, Denmark
Dep. of Rheumatology, Gentofte Hospital
Copenhagen, Denmark
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
Time frame: 24 weeks
Number of peripheral and axial joints and entheses with inflammation, circulating biomarkers of inflammation, cartilage and bone metabolism, conventional clinical parameters and changes in these during treatment with adalimumab.
Time frame: 24 week
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Dep. of Rheumatology, Hvidovre Hospital
Copenhagen, Denmark
Dep. of Rheumatologym Glostrup Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Helsinør Hospital
Hørsholm, Denmark
Dep. of Rheumatology, Køge Hospital
Køge, Denmark