The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
This multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of Ankylosing Spondylitis in subjects previously enrolled in Protocol 16.0037.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
257
Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites
Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains
Time frame: Up to 4 years
Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain
Time frame: Up to 4 years
DXA and MRI scans (at selected sites)
Time frame: Up to 144 weeks
X-rays of cervical spine and lumbosacral spine
Time frame: Up to 4 years
Type and grade of toxicities
Time frame: Up to 4 years
ASAS Response Criteria at weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, and the ASAS Response Criteria at 50% and 70% levels at weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 144.
Time frame: Up to 4 years
Frequency and time to partial remission as defined in Anderson, 2001: Value of <20 (on a scale of 0-100) in each of the following 4 domains: VAS Patient Global Assessment, VAS Pain Score, BASFI, and BASDAI morning stiffness-related scores
Time frame: Up to 4 years
Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance
Time frame: Up to 120 weeks
Complete joint assessment
Time frame: Up to 120 weeks
Laboratory assessment of inflammation using CRP
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Time frame: Up to 120 weeks
Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate
Time frame: Up to 4 years