Study Complete
Sponsor ID
20021640
16.0040 Ankylosing Spondylitis study
Study Details
The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
Protocol Summary
Primary Outcome Measures
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
Timeframe: 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
Timeframe: Up to 4 years
Secondary Outcome Measures
DXA and MRI scans (at selected sites)
Timeframe: Up to 144 weeks
X-rays of cervical spine and lumbosacral spine
Timeframe: Up to 4 years
Type and grade of toxicities
Timeframe: 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.
Timeframe: 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
Timeframe: Up to 4 years
Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance
Timeframe: Up to 120 weeks
Complete joint assessment
Timeframe: Up to 120 weeks
Laboratory assessment of inflammation using CRP
Timeframe: Up to 120 weeks
Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate
Timeframe: Up to 4 years
Locations
No locations found.