Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Last updated: September 2, 2020
Sponsor: Columbia University
Overall Status: Terminated

Phase

4

Condition

Ankylosing Spondylitis

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT03473665
AAAR3505
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A clinical diagnosis of ankylosing spondylitis (AS) by treating rheumatologists, or adiagnosis of axial spondyloarthritis (axSpA) with a pelvis MRI with significant bonemarrow 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 inthe past month) and willing to withhold medication for one week; or having activesymptoms that require initiation of NSAIDs;

  • Concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the pastthree months;

  • Have active disease after initial washout period, defined by BASDAI >=4/10, or backpain numerical rating scale (NRS)>=4/10

Exclusion

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 acuteperipheral arthritis;

  • Patients with a fibromyalgia score >= 13;

  • Patient with extensive cardiac history, history of gastrointestinal bleeding thatrequired blood transfusion, chronic kidney diseases, abnormal liver function tests; orfemale patients who are pregnant. Use of low-dose of aspirin (<100mg daily) is allowed in the study.

Study Design

Total Participants: 9
Study Start date:
March 01, 2018
Estimated Completion Date:
August 02, 2019

Study 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.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

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