Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

• Status: Terminated
• Trial end date: 2019-08-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Diclofenac; Indomethacin; Meloxicam

Criteria

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.