Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study

Conditions
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Ankylosing Spondylitis, Axial Spondyloarthritis

Intervention / Treatment
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* Drug: Indomethacin
* Drug: Diclofenac
* Drug: Meloxicam
* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Indomethacin<br>Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks | Drug: Indomethacin<br>* Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks<br>* Other names: Indomethacin ER;|
| Active Comparator: Diclofenac<br>Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks | Drug: Diclofenac<br>* Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks<br>* Other names: Voltarin;|
| Active Comparator: Meloxicam<br>Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks | Drug: Meloxicam<br>* meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks<br>* Other names: MLX;|
| Active Comparator: Celecoxib<br>Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks | Drug: Celecoxib<br>* Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks<br>* Other names: CEL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain Score | Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | Baseline, Week 4, and Week 6 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spondyloarthritis, ankylosing spondylitis