This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.
Name: Indomethacin
Description: Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeksType: DrugIndomethacin
Name: Diclofenac
Description: Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeksType: DrugDiclofenac
Name: Meloxicam
Description: meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeksType: DrugMeloxicam
Name: Celecoxib
Description: Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeksType: DrugCelecoxib
Description: change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Measure: change of pain score Time: at week 4 vs. at week 6Description: change of Bath Ankylosing Spondylitis Disease Activity Index from baseline [scale range: 0 (better) -10 (worse)]
Measure: change of BASDAI Time: at week 4 vs. at week 6Description: change of Bath Ankylosing Spondylitis Functional Index from baseline [scale range: 0 (better) -10 (worse)]
Measure: change of BASFI Time: at week 4 vs. at week 6Description: change of Ankylosing Spondylitis Disease Activity Score from baseline [composite score: 0 (no disease activity) - 6.5 (very high disease activity)]
Measure: change of ASDAS Time: at week 4 vs. at week 6Description: patient's global assessment of effectiveness of a treatment
Measure: Patient Global Assessment of Response to Therapy (PGART) Time: at week 6Allocation: Randomized
Parallel Assignment
There is one SNP
Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H ---
Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H --- --- Q12H ---
Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H --- --- Q12H --- --- Q12H ---
Ankylosing Spondylitis Axial Spondyloarthritis Spondylitis Spondylitis, Ankylosing Spondylarthritis Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg Q12H; 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. --- Q12H --- --- Q12H --- --- Q12H --- --- Q12H ---