The study has the aim to investigate the efficacy and safety of etanercept in patients with active ankylosing spondylitis (AS) over 520 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Etanercept 25 mg subcutaneously twice a week
Charite Campus Benjamin Franklin, Rheumatology
Berlin, Germany
Rheumazentrum Ruhrgebiet
Herne, 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 6 and 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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