The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare selective COX-2 and nonselective COX inhibitors impact on Health related Quality of Life (HrQOL) and how this relates to changes in disease activity and to conduct proteomic assessment of predictive biomarkers of non steroidal anti-inflammatory drug(NSAID) response
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS total score ranges from 0-10, with a higher score meaning worse disease activity. The change in score is reported as \[(ASDAS score at baseline) - (ASDAS score at 4 weeks)\]--a positive value indicates that the score (and disease activity) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Time frame: Baseline, 4 weeks
Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment
The Standard Gamble Utility assessment is scored between 0-1, with 0 being the worst outcome and 1 being the best outcome. The change in score is reported as \[(Standard Gamble score at baseline) - (Standard Gamble score at 4 weeks)\]--a negative value indicates that the Health Related Quality of Life increased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval.
Time frame: Baseline, 4 weeks
Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score
The reported Patient-Reported Outcomes Measurement Information System-Preference (PROPr) Score ranges from 0 to 1, with 0 being the worst outcome and 1 being the best outcome. The change in score is reported as \[(PROPr score at baseline) - (PROPR score at 4 weeks)\] - a negative value indicates that the person's Health Related Quality of Life increased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Time frame: Baseline, 4 weeks
Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges from 0-10, with 0 being easy and 10 being impossible. The change in score is reported as \[(BASFI score at baseline) - (BASFI score at 4 weeks)\], and a positive value indicates that the score (and difficulty with tasks) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Time frame: Baseline, 4 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem). The change in score is reported as \[(BASDAI score at baseline) - (BASDAI score at 4 weeks)\] -- a positive value indicates that the score (and disease activity) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Time frame: Baseline, 4 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI total score ranges from 0 - 10.The higher the BASMI score, the more severe the patient's limitation of movement due to their ankylosing spondylitis. The change in score is reported as \[(BASMI score at baseline) - (BASMI score at 4 weeks)\]--a positive value indicates that the score (and limitation of movement) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Time frame: Baseline, 4 weeks
Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS-Pain total score is 0 - 100, with 0 being no pain and 100 being unbearable pain. The change in score is reported as \[(VAS- Pain score at baseline) - (VAS- Pain score at 4 weeks)\] --a positive value indicates that the score (and pain level) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Time frame: Baseline, 4 weeks
Change in Visual Analog Scale-Global (VAS-Global)
The VAS-Global is scored from 0-100, with 0 being not active and 100 being very active. The change in score is reported as \[(VAS- Global score at baseline) - (VAS- Global score at 4 weeks)\] --a negative value indicates that the score (and activity level) increased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Time frame: Baseline, 4 weeks
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