The study has the aim to investigate the efficacy and safety of etanercept in patients with active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Etanercept 25 mg subcutaneously twice a week
Rheumazentrum Ruhrgebiet
Herne, Nordrhrein-Westfalen, Germany
Charite Campus Benjamin Franklin, Rheumatology
Berlin, State of Berlin, Germany
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response
Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline
Time frame: at week 12
Sustained response
Percentage of patients achieving the BASDAI50 response over time
Time frame: every 3 months througout the study
Safety outcome
Percentage of patients experienced adverse event during the study
Time frame: at 12 weeks, every 12 weeks thereafter
Magnetic resonance imaging (MRI) response
Reduction of inflammation seen on MRI in comparison to baseline
Time frame: at week 24, 54, 102, 210, 308, 416, 514
X-ray progression
Progression of the spinal structural changes as assessed by x-ray in comparison to baseline
Time frame: at week 54, 102, 210, 308, 514
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