Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Phase 4

Terminated

Interventions: Drug: Meloxicam
Drug: Indomethacin
Drug: Diclofenac
Drug: Celecoxib

Brief Summary: 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.

Detailed Description: 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 every 12 hours (Q12H); 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. The treatment length will be 6 weeks. Primary outcome is the change of pain score from baseline to week 4 and to week 6.

Recruitment & Eligibility

Inclusion Criteria

A clinical diagnosis of ankylosing spondylitis (AS) by treating rheumatologists, or a diagnosis of axial spondyloarthritis (axSpA) with a pelvis MRI with significant bone marrow edema on STIR sequences;
Minimum of 18 years old;
Are taking NSAIDs on a regular basis for AS or axSpA (defined as more than 20 days in the past month) and willing to withhold medication for one week; or having active symptoms that require initiation of NSAIDs;
Concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the past three months;
Have active disease after initial washout period, defined by BASDAI >=4/10, or back pain numerical rating scale (NRS)>=4/10

Exclusion Criteria

Patients who have concurrent rheumatic diseases other than AS or axSpA;
Patients who have oral corticosteroid in the past two weeks; patients who have acute peripheral arthritis;
Patients with a fibromyalgia score >= 13;
Patient with extensive cardiac history, history of gastrointestinal bleeding that required blood transfusion, chronic kidney diseases, abnormal liver function tests; or female patients who are pregnant.

Use of low-dose of aspirin (<100mg daily) is allowed in the study.

Arm && Interventions

Group	Intervention	Description
Meloxicam	Meloxicam	Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
Indomethacin	Indomethacin	Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Diclofenac	Diclofenac	Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Celecoxib	Celecoxib	Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change of Pain Score	Baseline, Week 4, and Week 6	Change of pain score by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]

Secondary Outcome Measures

Name	Time	Method
Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Baseline, Week 4, and Week 6	Change of BASDAI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Change of Bath Ankylosing Spondylitis Function Index (BASFI)	Baseline, Week 4, and Week 6	Change of BASFI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Change of ASAS Endorsed Disease Activity Score (ASDAS)	Baseline, Week 4, and Week 6	Change of ASDAS by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Patient Global Assessment of Response to Therapy (PGART)	Week 6	Likert Scale on whether effective or not.