Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
Stopped early · Phase 4
Conditions studied: Ankylosing Spondylitis, Axial Spondyloarthritis
In brief
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.
Key facts
- Study ID
- NCT03473665
- Run by
- Columbia University
- People needed
- 9
- Starts
- 2018-03-01
- Expected to finish
- 2019-08-02
- Last updated by the study team
- 2020-09-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Columbia University Irving Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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