Status:
TERMINATED
Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
Lead Sponsor:
Columbia University
Conditions:
Ankylosing Spondylitis
Axial Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 wee...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03473665
Start Date
March 1 2018
End Date
August 2 2019
Last Update
September 22 2020
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032